BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: BI 10773 low dose; Drug: Placebo BI 10773 high dose; Drug: BI 10773 high dose; Drug: Placebo BI 10773 low dose

• Study Type: Interventional
• Enrollment (Actual): 7064
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • 1245.25.54012 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1245.25.54001 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1245.25.54006 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1245.25.54013 Boehringer Ingelheim Investigational Site
  • Cordoba, Argentina
    • 1245.25.54010 Boehringer Ingelheim Investigational Site
  • Cordoba, Argentina
    • 1245.25.54011 Boehringer Ingelheim Investigational Site
  • Córdoba, Argentina
    • 1245.25.54002 Boehringer Ingelheim Investigational Site
  • Córdoba, Argentina
    • 1245.25.54003 Boehringer Ingelheim Investigational Site
  • Parque Velez Sarfield, Argentina
    • 1245.25.54005 Boehringer Ingelheim Investigational Site
  • Rosario, Argentina
    • 1245.25.54008 Boehringer Ingelheim Investigational Site
  • Rosario, Argentina
    • 1245.25.54009 Boehringer Ingelheim Investigational Site
• Australia
  • Queensland
    • Herston, Queensland, Australia
      • 1245.25.61003 Boehringer Ingelheim Investigational Site
  • South Australia
    • Ashford, South Australia, Australia
      • 1245.25.61001 Boehringer Ingelheim Investigational Site
    • Fullarton, South Australia, Australia
      • 1245.25.61002 Boehringer Ingelheim Investigational Site
• Austria
  • Feldkirch, Austria
    • 1245.25.43008 Boehringer Ingelheim Investigational Site
  • Graz, Austria
    • 1245.25.43006 Boehringer Ingelheim Investigational Site
  • Innsbruck, Austria
    • 1245.25.43016 Boehringer Ingelheim Investigational Site
  • Salzburg, Austria
    • 1245.25.43005 Boehringer Ingelheim Investigational Site
  • St. Stefan, Austria
    • 1245.25.43015 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.25.43001 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.25.43007 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.25.43009 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.25.43010 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.25.43013 Boehringer Ingelheim Investigational Site
• Belgium
  • Bonheiden, Belgium
    • 1245.25.32010 Boehringer Ingelheim Investigational Site
  • Brussel, Belgium
    • 1245.25.32030 Boehringer Ingelheim Investigational Site
  • Bruxelles, Belgium
    • 1245.25.32008 Boehringer Ingelheim Investigational Site
  • Bruxelles, Belgium
    • 1245.25.32011 Boehringer Ingelheim Investigational Site
  • De Pinte, Belgium
    • 1245.25.32003 Boehringer Ingelheim Investigational Site
  • Edegem, Belgium
    • 1245.25.32002 Boehringer Ingelheim Investigational Site
  • Genk, Belgium
    • 1245.25.32004 Boehringer Ingelheim Investigational Site
  • Halen, Belgium
    • 1245.25.32029 Boehringer Ingelheim Investigational Site
  • Hasselt, Belgium
    • 1245.25.32009 Boehringer Ingelheim Investigational Site
  • Huy, Belgium
    • 1245.25.32007 Boehringer Ingelheim Investigational Site
  • La Louvière, Belgium
    • 1245.25.32013 Boehringer Ingelheim Investigational Site
  • Leuven, Belgium
    • 1245.25.32012 Boehringer Ingelheim Investigational Site
  • Liège, Belgium
    • 1245.25.32001 Boehringer Ingelheim Investigational Site
  • Liège, Belgium
    • 1245.25.32028 Boehringer Ingelheim Investigational Site
  • Massemen-Wetteren, Belgium
    • 1245.25.32005 Boehringer Ingelheim Investigational Site
  • Oostham, Belgium
    • 1245.25.32014 Boehringer Ingelheim Investigational Site
• Brazil
  • Belo Horizonte, Brazil
    • 1245.25.55019 Boehringer Ingelheim Investigational Site
  • Belém, Brazil
    • 1245.25.55014 Boehringer Ingelheim Investigational Site
  • Boqueirão, Brazil
    • 1245.25.55007 Boehringer Ingelheim Investigational Site
  • Brasília, Brazil
    • 1245.25.55015 Boehringer Ingelheim Investigational Site
  • Campinas, Brazil
    • 1245.25.55027 Boehringer Ingelheim Investigational Site
  • Campinas, Brazil
    • 1245.25.55028 Boehringer Ingelheim Investigational Site
  • Curitiba, Brazil
    • 1245.25.55025 Boehringer Ingelheim Investigational Site
  • Fortaleza, Brazil
    • 1245.25.55026 Boehringer Ingelheim Investigational Site
  • Goiânia, Brazil
    • 1245.25.55009 Boehringer Ingelheim Investigational Site
  • Higienópolis, Brazil
    • 1245.25.55002 Boehringer Ingelheim Investigational Site
  • Marilia, Brazil
    • 1245.25.55017 Boehringer Ingelheim Investigational Site
  • Maringá, Brazil
    • 1245.25.55022 Boehringer Ingelheim Investigational Site
  • Porto Alegre, Brazil
    • 1245.25.55008 Boehringer Ingelheim Investigational Site
  • Porto Alegre, Brazil
    • 1245.25.55016 Boehringer Ingelheim Investigational Site
  • Porto Alegre, Brazil
    • 1245.25.55020 Boehringer Ingelheim Investigational Site
  • Ribeirão Preto, Brazil
    • 1245.25.55012 Boehringer Ingelheim Investigational Site
  • São José do Rio Preto, Brazil
    • 1245.25.55013 Boehringer Ingelheim Investigational Site
  • São Paulo, Brazil
    • 1245.25.55004 Boehringer Ingelheim Investigational Site
  • São Paulo, Brazil
    • 1245.25.55010 Boehringer Ingelheim Investigational Site
  • São Paulo, Brazil
    • 1245.25.55018 Boehringer Ingelheim Investigational Site
  • São Paulo, Brazil
    • 1245.25.55023 Boehringer Ingelheim Investigational Site
  • Vila Albuquerque, Brazil
    • 1245.25.55006 Boehringer Ingelheim Investigational Site
  • Vila Clementino, Brazil
    • 1245.25.55003 Boehringer Ingelheim Investigational Site
  • Vila Leopoldina, Brazil
    • 1245.25.55005 Boehringer Ingelheim Investigational Site
  • Villa Clementino, Brazil
    • 1245.25.55001 Boehringer Ingelheim Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • 1245.25.20047 Boehringer Ingelheim Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • 1245.25.20048 Boehringer Ingelheim Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • 1245.25.20026 Boehringer Ingelheim Investigational Site
  • Ontario
    • Brampton, Ontario, Canada
      • 1245.25.20045 Boehringer Ingelheim Investigational Site
    • Burlington, Ontario, Canada
      • 1245.25.20042 Boehringer Ingelheim Investigational Site
    • Newmarket, Ontario, Canada
      • 1245.25.20009 Boehringer Ingelheim Investigational Site
    • Niagara Falls, Ontario, Canada
      • 1245.25.20044 Boehringer Ingelheim Investigational Site
    • Ottawa, Ontario, Canada
      • 1245.25.20013 Boehringer Ingelheim Investigational Site
    • Toronto, Ontario, Canada
      • 1245.25.20049 Boehringer Ingelheim Investigational Site
  • Quebec
    • Gatineau, Quebec, Canada
      • 1245.25.20050 Boehringer Ingelheim Investigational Site
    • Longueuil, Quebec, Canada
      • 1245.25.20043 Boehringer Ingelheim Investigational Site
    • Longueuil, Quebec, Canada
      • 1245.25.20046 Boehringer Ingelheim Investigational Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • 1245.25.20041 Boehringer Ingelheim Investigational Site
• Colombia
  • Armenia, Colombia
    • 1245.25.57010 Boehringer Ingelheim Investigational Site
  • Barranquilla, Colombia
    • 1245.25.57004 Boehringer Ingelheim Investigational Site
  • Bogotá, Colombia
    • 1245.25.57001 Boehringer Ingelheim Investigational Site
  • Bogotá, Colombia
    • 1245.25.57003 Boehringer Ingelheim Investigational Site
  • Bogotá, Colombia
    • 1245.25.57011 Boehringer Ingelheim Investigational Site
  • Floridablanca, Colombia
    • 1245.25.57006 Boehringer Ingelheim Investigational Site
  • Medellín, Colombia
    • 1245.25.57009 Boehringer Ingelheim Investigational Site
• Croatia
  • Karlovac, Croatia
    • 1245.25.71005 Boehringer Ingelheim Investigational Site
  • Krapinske Toplice, Croatia
    • 1245.25.71001 Boehringer Ingelheim Investigational Site
  • Osijek, Croatia
    • 1245.25.71006 Boehringer Ingelheim Investigational Site
  • Rijeka, Croatia
    • 1245.25.71003 Boehringer Ingelheim Investigational Site
  • Zagreb, Croatia
    • 1245.25.71002 Boehringer Ingelheim Investigational Site
  • Zagreb, Croatia
    • 1245.25.71004 Boehringer Ingelheim Investigational Site
• Czech Republic
  • Brno, Czech Republic
    • 1245.25.42020 Boehringer Ingelheim Investigational Site
  • Jindrichuv Hradec, Czech Republic
    • 1245.25.42018 Boehringer Ingelheim Investigational Site
  • Praha 3, Czech Republic
    • 1245.25.42015 Boehringer Ingelheim Investigational Site
  • Usti nad Labem, Czech Republic
    • 1245.25.42019 Boehringer Ingelheim Investigational Site
• Denmark
  • Frederiksberg, Denmark
    • 1245.25.45006 Boehringer Ingelheim Investigational Site
  • Gentofte, Denmark
    • 1245.25.45003 Boehringer Ingelheim Investigational Site
  • Helsingør, Denmark
    • 1245.25.45007 Boehringer Ingelheim Investigational Site
  • København NV, Denmark
    • 1245.25.45002 Boehringer Ingelheim Investigational Site
  • Randers NØ, Denmark
    • 1245.25.45004 Boehringer Ingelheim Investigational Site
  • Slagelse, Denmark
    • 1245.25.45005 Boehringer Ingelheim Investigational Site
• Estonia
  • Tallin, Estonia
    • 1245.25.37002 Boehringer Ingelheim Investigational Site
  • Tallin, Estonia
    • 1245.25.37005 Boehringer Ingelheim Investigational Site
  • Tallinn, Estonia
    • 1245.25.37003 Boehringer Ingelheim Investigational Site
  • Tartu, Estonia
    • 1245.25.37001 Boehringer Ingelheim Investigational Site
  • Tartu, Estonia
    • 1245.25.37004 Boehringer Ingelheim Investigational Site
• France
  • Amiens, France
    • 1245.25.33022 Boehringer Ingelheim Investigational Site
  • Angers, France
    • 1245.25.33033 Boehringer Ingelheim Investigational Site
  • Angers, France
    • 1245.25.33034 Boehringer Ingelheim Investigational Site
  • Bourg des cptes, France
    • 1245.25.33030 Boehringer Ingelheim Investigational Site
  • Corbeil Essonnes, France
    • 1245.25.33023 Boehringer Ingelheim Investigational Site
  • Derval, France
    • 1245.25.33024 Boehringer Ingelheim Investigational Site
  • Equeurdreville Haineville, France
    • 1245.25.33029 Boehringer Ingelheim Investigational Site
  • Fleury sur Orne, France
    • 1245.25.33027 Boehringer Ingelheim Investigational Site
  • Grenoble, France
    • 1245.25.33021 Boehringer Ingelheim Investigational Site
  • La Rochelle Cedex 1, France
    • 1245.25.33003 Boehringer Ingelheim Investigational Site
  • Le Creusot, France
    • 1245.25.33032 Boehringer Ingelheim Investigational Site
  • Narbonne Cedex, France
    • 1245.25.33004 Boehringer Ingelheim Investigational Site
  • Pessac, France
    • 1245.25.33047 Boehringer Ingelheim Investigational Site
  • Poitiers, France
    • 1245.25.33046 Boehringer Ingelheim Investigational Site
  • Saint Priez en Jarez, France
    • 1245.25.33025 Boehringer Ingelheim Investigational Site
  • Tours, France
    • 1245.25.33035 Boehringer Ingelheim Investigational Site
• Georgia
  • Batumi, Georgia
    • 1245.25.99001 Boehringer Ingelheim Investigational Site
  • Kutaisi, Georgia
    • 1245.25.99003 Boehringer Ingelheim Investigational Site
  • Tbilisi, Georgia
    • 1245.25.99002 Boehringer Ingelheim Investigational Site
  • Tbilisi, Georgia
    • 1245.25.99004 Boehringer Ingelheim Investigational Site
  • Tbilisi, Georgia
    • 1245.25.99005 Boehringer Ingelheim Investigational Site
  • Tbilisi, Georgia
    • 1245.25.99006 Boehringer Ingelheim Investigational Site
  • Tbilisi, Georgia
    • 1245.25.99007 Boehringer Ingelheim Investigational Site
  • Tbilisi, Georgia
    • 1245.25.99008 Boehringer Ingelheim Investigational Site
• Greece
  • Athens, Greece
    • 1245.25.30002 Boehringer Ingelheim Investigational Site
  • Athens, Greece
    • 1245.25.30003 Boehringer Ingelheim Investigational Site
  • Athens, Greece
    • 1245.25.30004 Boehringer Ingelheim Investigational Site
  • Athens, Greece
    • 1245.25.30007 Boehringer Ingelheim Investigational Site
  • Larissa, Greece
    • 1245.25.30005 Boehringer Ingelheim Investigational Site
  • Nikaia, Greece
    • 1245.25.30001 Boehringer Ingelheim Investigational Site
  • Thessaloniki, Greece
    • 1245.25.30006 Boehringer Ingelheim Investigational Site
  • Thessaloniki, Greece
    • 1245.25.30008 Boehringer Ingelheim Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • 1245.25.85201 Boehringer Ingelheim Investigational Site
  • Hong Kong, Hong Kong
    • 1245.25.85205 Boehringer Ingelheim Investigational Site
  • Hong Kong, Hong Kong
    • 1245.25.85207 Boehringer Ingelheim Investigational Site
  • Hong Kong, Hong Kong
    • 1245.25.85208 Boehringer Ingelheim Investigational Site
• Hungary
  • Budapest, Hungary
    • 1245.25.36002 Boehringer Ingelheim Investigational Site
  • Budapest, Hungary
    • 1245.25.36004 Boehringer Ingelheim Investigational Site
  • Budapest, Hungary
    • 1245.25.36008 Boehringer Ingelheim Investigational Site
  • Dunaujvaros, Hungary
    • 1245.25.36006 Boehringer Ingelheim Investigational Site
  • Gyula, Hungary
    • 1245.25.36001 Boehringer Ingelheim Investigational Site
  • Kisvarda, Hungary
    • 1245.25.36010 Boehringer Ingelheim Investigational Site
  • Szekszard, Hungary
    • 1245.25.36003 Boehringer Ingelheim Investigational Site
  • Szikszo, Hungary
    • 1245.25.36011 Boehringer Ingelheim Investigational Site
• India
  • Ahmedabad, India
    • 1245.25.91307 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.25.91302 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.25.91317 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.25.91319 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.25.91320 Boehringer Ingelheim Investigational Site
  • Chennai, India
    • 1245.25.91303 Boehringer Ingelheim Investigational Site
  • Cochin, India
    • 1245.25.91315 Boehringer Ingelheim Investigational Site
  • Hyderabad, India
    • 1245.25.91311 Boehringer Ingelheim Investigational Site
  • Indore, India
    • 1245.25.91318 Boehringer Ingelheim Investigational Site
  • Jaipur, India
    • 1245.25.91305 Boehringer Ingelheim Investigational Site
  • Jalandhar, India
    • 1245.25.91309 Boehringer Ingelheim Investigational Site
  • Nagpur, India
    • 1245.25.91313 Boehringer Ingelheim Investigational Site
  • Nagpur, India
    • 1245.25.91324 Boehringer Ingelheim Investigational Site
  • Nashik, Maharashtra, India
    • 1245.25.91301 Boehringer Ingelheim Investigational Site
  • Pune, India
    • 1245.25.91308 Boehringer Ingelheim Investigational Site
  • Secunderabad, India
    • 1245.25.91316 Boehringer Ingelheim Investigational Site
  • Varanasi, India
    • 1245.25.91321 Boehringer Ingelheim Investigational Site
  • Vijaywada, India
    • 1245.25.91314 Boehringer Ingelheim Investigational Site
• Indonesia
  • Denpasar, Bali, Indonesia
    • 1245.25.62006 Boehringer Ingelheim Investigational Site
  • Depok, Indonesia
    • 1245.25.62009 Boehringer Ingelheim Investigational Site
  • Jakarta, Indonesia
    • 1245.25.62002 Boehringer Ingelheim Investigational Site
  • Jakarta, Indonesia
    • 1245.25.62008 Boehringer Ingelheim Investigational Site
  • Jakarta, Indonesia
    • 1245.25.62010 Boehringer Ingelheim Investigational Site
  • Malang, Indonesia
    • 1245.25.62004 Boehringer Ingelheim Investigational Site
  • Surabaya, Indonesia
    • 1245.25.62003 Boehringer Ingelheim Investigational Site
  • Yogyakarta, Indonesia
    • 1245.25.62001 Boehringer Ingelheim Investigational Site
• Israel
  • Afula, Israel
    • 1245.25.97003 Boehringer Ingelheim Investigational Site
  • Hadera, Israel
    • 1245.25.97006 Boehringer Ingelheim Investigational Site
  • Haifa, Israel
    • 1245.25.97008 Boehringer Ingelheim Investigational Site
  • Holon, Israel
    • 1245.25.97009 Boehringer Ingelheim Investigational Site
  • Nahariya, Israel
    • 1245.25.97005 Boehringer Ingelheim Investigational Site
  • Safed, Israel
    • 1245.25.97001 Boehringer Ingelheim Investigational Site
  • Zerifin, Israel
    • 1245.25.97002 Boehringer Ingelheim Investigational Site
• Italy
  • Bologna, Italy
    • 1245.25.39007 Boehringer Ingelheim Investigational Site
  • Campobasso, Italy
    • 1245.25.39002 Boehringer Ingelheim Investigational Site
  • Catanzaro, Italy
    • 1245.25.39008 Boehringer Ingelheim Investigational Site
  • Chieti, Italy
    • 1245.25.39010 Boehringer Ingelheim Investigational Site
  • Ferrara, Italy
    • 1245.25.39024 Boehringer Ingelheim Investigational Site
  • Firenze, Italy
    • 1245.25.39009 Boehringer Ingelheim Investigational Site
  • Foggia, Italy
    • 1245.25.39005 Boehringer Ingelheim Investigational Site
  • Napoli, Italy
    • 1245.25.39004 Boehringer Ingelheim Investigational Site
  • Padova, Italy
    • 1245.25.39006 Boehringer Ingelheim Investigational Site
  • Pisa, Italy
    • 1245.25.39001 Boehringer Ingelheim Investigational Site
  • Roma, Italy
    • 1245.25.39003 Boehringer Ingelheim Investigational Site
  • Roma, Italy
    • 1245.25.39011 Boehringer Ingelheim Investigational Site
  • Roma, Italy
    • 1245.25.39012 Boehringer Ingelheim Investigational Site
  • Roma, Italy
    • 1245.25.39014 Boehringer Ingelheim Investigational Site
  • Venezia, Italy
    • 1245.25.39013 Boehringer Ingelheim Investigational Site
• Japan
  • Chuo-ku, tokyo, Japan
    • 1245.25.81008 Boehringer Ingelheim Investigational Site
  • Gifushi, Gifu, Japan
    • 1245.25.81010 Boehringer Ingelheim Investigational Site
  • Hanyushi, Saitama, Japan
    • 1245.25.81002 Boehringer Ingelheim Investigational Site
  • Kamigyo-ku, Kyotoshi, Kyoto, Japan
    • 1245.25.81013 Boehringer Ingelheim Investigational Site
  • Kishiwadashi. Osaka, Japan
    • 1245.25.81003 Boehringer Ingelheim Investigational Site
  • Kita-ku, Nagoyashi, Aichi, Japan
    • 1245.25.81012 Boehringer Ingelheim Investigational Site
  • Kumamoto-shi, Kumamoto, Japan
    • 1245.25.81014 Boehringer Ingelheim Investigational Site
  • Matsudoshi, Chiba, Japan
    • 1245.25.81001 Boehringer Ingelheim Investigational Site
  • Mitoshi, Ibaraki, Japan
    • 1245.25.81006 Boehringer Ingelheim Investigational Site
  • Nishi-ku, Sapporoshi, Hokkaido, Japan
    • 1245.25.81005 Boehringer Ingelheim Investigational Site
  • Nodashi, Chiba, Japan
    • 1245.25.81007 Boehringer Ingelheim Investigational Site
  • Shimajiri-gun,Okinawa, Japan
    • 1245.25.81004 Boehringer Ingelheim Investigational Site
  • Toyamashi, Toyama, Japan
    • 1245.25.81009 Boehringer Ingelheim Investigational Site
  • Toyoakeshi, Aichi, Japan
    • 1245.25.81015 Boehringer Ingelheim Investigational Site
• Korea, Republic of
  • Busan, Korea, Republic of
    • 1245.25.82030 Boehringer Ingelheim Investigational Site
  • Daegu, Korea, Republic of
    • 1245.25.82018 Boehringer Ingelheim Investigational Site
  • Daejeon, Korea, Republic of
    • 1245.25.82021 Boehringer Ingelheim Investigational Site
  • Daejoen, Korea, Republic of
    • 1245.25.82031 Boehringer Ingelheim Investigational Site
  • Goyang, Korea, Republic of
    • 1245.25.82027 Boehringer Ingelheim Investigational Site
  • Gwangju, Korea, Republic of
    • 1245.25.82022 Boehringer Ingelheim Investigational Site
  • Incheon, Korea, Republic of
    • 1245.25.82029 Boehringer Ingelheim Investigational Site
  • Pusan, Korea, Republic of
    • 1245.25.82017 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.25.82015 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.25.82016 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.25.82019 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.25.82020 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.25.82023 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.25.82024 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.25.82025 Boehringer Ingelheim Investigational Site
  • Suwon, Korea, Republic of
    • 1245.25.82026 Boehringer Ingelheim Investigational Site
  • Wonju, Korea, Republic of
    • 1245.25.82028 Boehringer Ingelheim Investigational Site
• Malaysia
  • Johor Bahru, Malaysia
    • 1245.25.60019 Boehringer Ingelheim Investigational Site
  • Kedah, Malaysia
    • 1245.25.60020 Boehringer Ingelheim Investigational Site
  • Kelantan, Malaysia
    • 1245.25.60013 Boehringer Ingelheim Investigational Site
  • Kota Kinabalu, Malaysia
    • 1245.25.60015 Boehringer Ingelheim Investigational Site
  • Kuala Lumpur, Malaysia
    • 1245.25.60012 Boehringer Ingelheim Investigational Site
  • Kuala Lumpur, Malaysia
    • 1245.25.60017 Boehringer Ingelheim Investigational Site
  • Pahang, Malaysia
    • 1245.25.60004 Boehringer Ingelheim Investigational Site
  • Selangor, Malaysia
    • 1245.25.60016 Boehringer Ingelheim Investigational Site
  • Selangor, Malaysia
    • 1245.25.60021 Boehringer Ingelheim Investigational Site
  • Selangor Darul Ehsan, Malaysia
    • 1245.25.60018 Boehringer Ingelheim Investigational Site
• Mexico
  • Colonia Americana, Mexico
    • 1245.25.52009 Boehringer Ingelheim Investigational Site
  • Distrito Federal, Mexico
    • 1245.25.52007 Boehringer Ingelheim Investigational Site
  • Ladron de Guevara, Mexico
    • 1245.25.52013 Boehringer Ingelheim Investigational Site
  • Los Robles, Mexico
    • 1245.25.52010 Boehringer Ingelheim Investigational Site
  • Monterrey, Mexico
    • 1245.25.52001 Boehringer Ingelheim Investigational Site
  • Reforma Social, Mexico
    • 1245.25.52011 Boehringer Ingelheim Investigational Site
  • San Lucas tepetlcalco, Mexico
    • 1245.25.52012 Boehringer Ingelheim Investigational Site
• Netherlands
  • Amersfoort, Netherlands
    • 1245.25.31015 Boehringer Ingelheim Investigational Site
  • Apeldoorn, Netherlands
    • 1245.25.31013 Boehringer Ingelheim Investigational Site
  • Baarle - Nassau, Netherlands
    • 1245.25.31036 Boehringer Ingelheim Investigational Site
  • Delft, Netherlands
    • 1245.25.31032 Boehringer Ingelheim Investigational Site
  • Den Helder, Netherlands
    • 1245.25.31026 Boehringer Ingelheim Investigational Site
  • Geleen, Netherlands
    • 1245.25.31012 Boehringer Ingelheim Investigational Site
  • Hardenberg, Netherlands
    • 1245.25.31017 Boehringer Ingelheim Investigational Site
  • Heerlen, Netherlands
    • 1245.25.31035 Boehringer Ingelheim Investigational Site
  • Hoogeveen, Netherlands
    • 1245.25.31011 Boehringer Ingelheim Investigational Site
  • Hoogezand, Netherlands
    • 1245.25.31029 Boehringer Ingelheim Investigational Site
  • Hoogwoud, Netherlands
    • 1245.25.31023 Boehringer Ingelheim Investigational Site
  • Maastricht, Netherlands
    • 1245.25.31009 Boehringer Ingelheim Investigational Site
  • Meppel, Netherlands
    • 1245.25.31031 Boehringer Ingelheim Investigational Site
  • Nijverdal, Netherlands
    • 1245.25.31024 Boehringer Ingelheim Investigational Site
  • Rotterdam, Netherlands
    • 1245.25.31014 Boehringer Ingelheim Investigational Site
  • Rotterdam, Netherlands
    • 1245.25.31033 Boehringer Ingelheim Investigational Site
  • Schiedam, Netherlands
    • 1245.25.31030 Boehringer Ingelheim Investigational Site
  • Utrecht, Netherlands
    • 1245.25.31002 Boehringer Ingelheim Investigational Site
  • Wildervank, Netherlands
    • 1245.25.31028 Boehringer Ingelheim Investigational Site
  • Zutphen, Netherlands
    • 1245.25.31034 Boehringer Ingelheim Investigational Site
• New Zealand
  • Christchurch, New Zealand
    • 1245.25.64004 Boehringer Ingelheim Investigational Site
  • Grafton / Auckland, New Zealand
    • 1245.25.64001 Boehringer Ingelheim Investigational Site
  • Wellington, New Zealand
    • 1245.25.64003 Boehringer Ingelheim Investigational Site
• Norway
  • Fornebu, Norway
    • 1245.25.47002 Boehringer Ingelheim Investigational Site
  • Gjøvik, Norway
    • 1245.25.47004 Boehringer Ingelheim Investigational Site
  • Kløfta, Norway
    • 1245.25.47009 Boehringer Ingelheim Investigational Site
  • Kongsvinger, Norway
    • 1245.25.47008 Boehringer Ingelheim Investigational Site
  • Oslo, Norway
    • 1245.25.47001 Boehringer Ingelheim Investigational Site
  • Oslo, Norway
    • 1245.25.47006 Boehringer Ingelheim Investigational Site
  • Trondheim, Norway
    • 1245.25.47007 Boehringer Ingelheim Investigational Site
  • Tynset, Norway
    • 1245.25.47005 Boehringer Ingelheim Investigational Site
• Peru
  • Arequipa, Peru
    • 1245.25.51001 Boehringer Ingelheim Investigational Site
  • Arequipa, Peru
    • 1245.25.51008 Boehringer Ingelheim Investigational Site
  • Bellavista, Peru
    • 1245.25.51002 Boehringer Ingelheim Investigational Site
  • El Agustino, Peru
    • 1245.25.51004 Boehringer Ingelheim Investigational Site
  • Ica, Peru
    • 1245.25.51006 Boehringer Ingelheim Investigational Site
  • Jesus Maria, Peru
    • 1245.25.51003 Boehringer Ingelheim Investigational Site
  • Lima, Peru
    • 1245.25.51007 Boehringer Ingelheim Investigational Site
  • Lima, Peru
    • 1245.25.51009 Boehringer Ingelheim Investigational Site
  • Lima, Peru
    • 1245.25.51010 Boehringer Ingelheim Investigational Site
  • Lima, Peru
    • 1245.25.51011 Boehringer Ingelheim Investigational Site
  • Miraflores, Peru
    • 1245.25.51005 Boehringer Ingelheim Investigational Site
• Philippines
  • Cavite City, Philippines
    • 1245.25.63016 Boehringer Ingelheim Investigational Site
  • Cebu, Philippines
    • 1245.25.63002 Boehringer Ingelheim Investigational Site
  • Davao, Philippines
    • 1245.25.63003 Boehringer Ingelheim Investigational Site
  • Jaro Iloilo City, Philippines
    • 1245.25.63020 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.25.63001 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.25.63004 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.25.63018 Boehringer Ingelheim Investigational Site
  • Marikina City, Philippines
    • 1245.25.63009 Boehringer Ingelheim Investigational Site
  • Marikina City, Philippines
    • 1245.25.63021 Boehringer Ingelheim Investigational Site
  • Tarlac, Philippines
    • 1245.25.63019 Boehringer Ingelheim Investigational Site
• Poland
  • Gdansk, Poland
    • 1245.25.48013 Boehringer Ingelheim Investigational Site
  • Lodz, Poland
    • 1245.25.48004 Boehringer Ingelheim Investigational Site
  • Lodz, Poland
    • 1245.25.48009 Boehringer Ingelheim Investigational Site
  • Lodz, Poland
    • 1245.25.48010 Boehringer Ingelheim Investigational Site
  • Lublin, Poland
    • 1245.25.48001 Boehringer Ingelheim Investigational Site
  • Oswiecim, Poland
    • 1245.25.48014 Boehringer Ingelheim Investigational Site
  • Poznan, Poland
    • 1245.25.48002 Boehringer Ingelheim Investigational Site
  • Pulawy, Poland
    • 1245.25.48008 Boehringer Ingelheim Investigational Site
  • Ruda Slaska, Poland
    • 1245.25.48007 Boehringer Ingelheim Investigational Site
  • Torun, Poland
    • 1245.25.48005 Boehringer Ingelheim Investigational Site
  • Torun, Poland
    • 1245.25.48011 Boehringer Ingelheim Investigational Site
• Portugal
  • Amadora, Portugal
    • 1245.25.35006 Boehringer Ingelheim Investigational Site
  • Coimbra, Portugal
    • 1245.25.35004 Boehringer Ingelheim Investigational Site
  • Faro, Portugal
    • 1245.25.35018 Boehringer Ingelheim Investigational Site
  • Funchal, Portugal
    • 1245.25.35021 Boehringer Ingelheim Investigational Site
  • Leiria, Portugal
    • 1245.25.35008 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1245.25.35001 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1245.25.35002 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1245.25.35015 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1245.25.35017 Boehringer Ingelheim Investigational Site
  • Porto, Portugal
    • 1245.25.35011 Boehringer Ingelheim Investigational Site
  • Santiago do Cacém, Portugal
    • 1245.25.35005 Boehringer Ingelheim Investigational Site
  • Torres Novas, Portugal
    • 1245.25.35020 Boehringer Ingelheim Investigational Site
  • Viana do Castelo, Portugal
    • 1245.25.35014 Boehringer Ingelheim Investigational Site
  • Vila Nova de Gaia, Portugal
    • 1245.25.35019 Boehringer Ingelheim Investigational Site
• Romania
  • Alba Iulia, Romania
    • 1245.25.40008 Boehringer Ingelheim Investigational Site
  • Baia Mare Maramures, Romania
    • 1245.25.40011 Boehringer Ingelheim Investigational Site
  • Bucharest, Romania
    • 1245.25.40003 Boehringer Ingelheim Investigational Site
  • Bucharest, Romania
    • 1245.25.40007 Boehringer Ingelheim Investigational Site
  • Constanta, Romania
    • 1245.25.40005 Boehringer Ingelheim Investigational Site
  • Craiova, Romania
    • 1245.25.40002 Boehringer Ingelheim Investigational Site
  • Craiova, Romania
    • 1245.25.40006 Boehringer Ingelheim Investigational Site
  • Oradea, Romania
    • 1245.25.40009 Boehringer Ingelheim Investigational Site
  • Targu-Mures, Romania
    • 1245.25.40010 Boehringer Ingelheim Investigational Site
• Russian Federation
  • Barnaul, Russian Federation
    • 1245.25.70019 Boehringer Ingelheim Investigational Site
  • Kemerovo, Russian Federation
    • 1245.25.70015 Boehringer Ingelheim Investigational Site
  • Kemerovo, Russian Federation
    • 1245.25.70020 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1245.25.70003 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1245.25.70009 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1245.25.70011 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1245.25.70016 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1245.25.70021 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1245.25.70022 Boehringer Ingelheim Investigational Site
  • Novosibirsk, Russian Federation
    • 1245.25.70014 Boehringer Ingelheim Investigational Site
  • Novosibirsk, Russian Federation
    • 1245.25.70018 Boehringer Ingelheim Investigational Site
  • Novosibirsk, Russian Federation
    • 1245.25.70024 Boehringer Ingelheim Investigational Site
  • Novosibirsk, Russian Federation
    • 1245.25.70028 Boehringer Ingelheim Investigational Site
  • Saint Petersburg, Russian Federation
    • 1245.25.70005 Boehringer Ingelheim Investigational Site
  • Saint Petersburg, Russian Federation
    • 1245.25.70025 Boehringer Ingelheim Investigational Site
  • Saint Petersburg, Russian Federation
    • 1245.25.70026 Boehringer Ingelheim Investigational Site
  • Saint Petersburg, Russian Federation
    • 1245.25.70027 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1245.25.70001 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1245.25.70004 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1245.25.70006 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1245.25.70013 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1245.25.70017 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1245.25.70023 Boehringer Ingelheim Investigational Site
  • Vsevolozhsk, Russian Federation
    • 1245.25.70002 Boehringer Ingelheim Investigational Site
  • Yaroslavl, Russian Federation
    • 1245.25.70029 Boehringer Ingelheim Investigational Site
• Singapore
  • Singapore, Singapore
    • 1245.25.65001 Boehringer Ingelheim Investigational Site
  • Singapore, Singapore
    • 1245.25.65003 Boehringer Ingelheim Investigational Site
  • Singapore, Singapore
    • 1245.25.65004 Boehringer Ingelheim Investigational Site
• South Africa
  • Alberton, South Africa
    • 1245.25.76007 Boehringer Ingelheim Investigational Site
  • Bellville, South Africa
    • 1245.25.76002 Boehringer Ingelheim Investigational Site
  • Bloemfontein, South Africa
    • 1245.25.76009 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 1245.25.76014 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 1245.25.76020 Boehringer Ingelheim Investigational Site
  • Chatsworth Unit 10, South Africa
    • 1245.25.76022 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 1245.25.76013 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 1245.25.76016 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 1245.25.76019 Boehringer Ingelheim Investigational Site
  • Goodwood, South Africa
    • 1245.25.76003 Boehringer Ingelheim Investigational Site
  • Houghton, South Africa
    • 1245.25.76001 Boehringer Ingelheim Investigational Site
  • Kempton Park, South Africa
    • 1245.25.76021 Boehringer Ingelheim Investigational Site
  • Krugersdorp, South Africa
    • 1245.25.76017 Boehringer Ingelheim Investigational Site
  • Newtown, South Africa
    • 1245.25.76004 Boehringer Ingelheim Investigational Site
  • Paarl, South Africa
    • 1245.25.76006 Boehringer Ingelheim Investigational Site
  • Parow, South Africa
    • 1245.25.76005 Boehringer Ingelheim Investigational Site
  • Port Elizabeth, South Africa
    • 1245.25.76018 Boehringer Ingelheim Investigational Site
  • Somerset West, South Africa
    • 1245.25.76015 Boehringer Ingelheim Investigational Site
  • Sydenham, South Africa
    • 1245.25.76012 Boehringer Ingelheim Investigational Site
  • Tongaat, South Africa
    • 1245.25.76008 Boehringer Ingelheim Investigational Site
  • Worcester, South Africa
    • 1245.25.76023 Boehringer Ingelheim Investigational Site
• Spain
  • Alcorcon (Madrid), Spain
    • 1245.25.34025 Boehringer Ingelheim Investigational Site
  • Alicante, Spain
    • 1245.25.34048 Boehringer Ingelheim Investigational Site
  • Alzira, Spain
    • 1245.25.34050 Boehringer Ingelheim Investigational Site
  • Avila, Spain
    • 1245.25.34039 Boehringer Ingelheim Investigational Site
  • Badía del Vallès - Barcelona, Spain
    • 1245.25.34040 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1245.25.34029 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1245.25.34030 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1245.25.34049 Boehringer Ingelheim Investigational Site
  • Granada, Spain
    • 1245.25.34031 Boehringer Ingelheim Investigational Site
  • Leganes (Madrid), Spain
    • 1245.25.34024 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.25.34013 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.25.34023 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.25.34026 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.25.34028 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.25.34033 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.25.34036 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.25.34038 Boehringer Ingelheim Investigational Site
  • Mahadahonda (Madrid), Spain
    • 1245.25.34022 Boehringer Ingelheim Investigational Site
  • Palma de Mallorca, Spain
    • 1245.25.34047 Boehringer Ingelheim Investigational Site
  • Sabadell (Barcelona), Spain
    • 1245.25.34034 Boehringer Ingelheim Investigational Site
  • Salamanca, Spain
    • 1245.25.34027 Boehringer Ingelheim Investigational Site
  • Santa Cruz de Tenerife, Spain
    • 1245.25.34037 Boehringer Ingelheim Investigational Site
  • Segovia, Spain
    • 1245.25.34046 Boehringer Ingelheim Investigational Site
• Sri Lanka
  • Colombo, Sri Lanka
    • 1245.25.94002 Boehringer Ingelheim Investigational Site
  • Kalubowila, Sri Lanka
    • 1245.25.94005 Boehringer Ingelheim Investigational Site
  • Kandy, Sri Lanka
    • 1245.25.94004 Boehringer Ingelheim Investigational Site
  • Kandy, Sri Lanka
    • 1245.25.94006 Boehringer Ingelheim Investigational Site
  • Nugegoda, Sri Lanka
    • 1245.25.94001 Boehringer Ingelheim Investigational Site
  • Ragama, Sri Lanka
    • 1245.25.94003 Boehringer Ingelheim Investigational Site
• Taiwan
  • Hualien, Taiwan
    • 1245.25.88022 Boehringer Ingelheim Investigational Site
  • Kaohsiung, Taiwan
    • 1245.25.88010 Boehringer Ingelheim Investigational Site
  • Kaohsiung, Taiwan
    • 1245.25.88019 Boehringer Ingelheim Investigational Site
  • Taichung, Taiwan
    • 1245.25.88009 Boehringer Ingelheim Investigational Site
  • Taichung, Taiwan
    • 1245.25.88020 Boehringer Ingelheim Investigational Site
  • Tainan, Taiwan
    • 1245.25.88018 Boehringer Ingelheim Investigational Site
  • Taipei, Taiwan
    • 1245.25.88015 Boehringer Ingelheim Investigational Site
  • Taipei, Taiwan
    • 1245.25.88016 Boehringer Ingelheim Investigational Site
  • Tamsui, Taipei county, Taiwan
    • 1245.25.88023 Boehringer Ingelheim Investigational Site
  • Taoyuan, Taiwan
    • 1245.25.88017 Boehringer Ingelheim Investigational Site
• Thailand
  • Bangkok, Thailand
    • 1245.25.66006 Boehringer Ingelheim Investigational Site
  • Bangkok, Thailand
    • 1245.25.66007 Boehringer Ingelheim Investigational Site
  • Chiang Mai, Thailand
    • 1245.25.66009 Boehringer Ingelheim Investigational Site
  • Muang District, Thailand
    • 1245.25.66004 Boehringer Ingelheim Investigational Site
  • Nakhonratchasima, Thailand
    • 1245.25.66010 Boehringer Ingelheim Investigational Site
  • Pathum Tani, Thailand
    • 1245.25.66011 Boehringer Ingelheim Investigational Site
• Ukraine
  • Kharkiv, Ukraine
    • 1245.25.75009 Boehringer Ingelheim Investigational Site
  • Kharkiv, Ukraine
    • 1245.25.75011 Boehringer Ingelheim Investigational Site
  • Kharkov, Ukraine
    • 1245.25.75001 Boehringer Ingelheim Investigational Site
  • Kharkov, Ukraine
    • 1245.25.75008 Boehringer Ingelheim Investigational Site
  • Kiev, Ukraine
    • 1245.25.75007 Boehringer Ingelheim Investigational Site
  • Kiev, Ukraine
    • 1245.25.75012 Boehringer Ingelheim Investigational Site
  • Odessa, Ukraine
    • 1245.25.75010 Boehringer Ingelheim Investigational Site
• United Kingdom
  • Airdrie, United Kingdom
    • 1245.25.44045 Boehringer Ingelheim Investigational Site
  • Ashford, United Kingdom
    • 1245.25.44020 Boehringer Ingelheim Investigational Site
  • Blackpool, United Kingdom
    • 1245.25.44013 Boehringer Ingelheim Investigational Site
  • Bolton, United Kingdom
    • 1245.25.44014 Boehringer Ingelheim Investigational Site
  • Bradford on Avon, United Kingdom
    • 1245.25.44021 Boehringer Ingelheim Investigational Site
  • Dumfries, United Kingdom
    • 1245.25.44002 Boehringer Ingelheim Investigational Site
  • Dundee, United Kingdom
    • 1245.25.44009 Boehringer Ingelheim Investigational Site
  • Edinburgh, United Kingdom
    • 1245.25.44005 Boehringer Ingelheim Investigational Site
  • Fowey, United Kingdom
    • 1245.25.44004 Boehringer Ingelheim Investigational Site
  • Frome, United Kingdom
    • 1245.25.44001 Boehringer Ingelheim Investigational Site
  • Inverness, United Kingdom
    • 1245.25.44003 Boehringer Ingelheim Investigational Site
  • Wishaw, United Kingdom
    • 1245.25.44044 Boehringer Ingelheim Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • 1245.25.10043 Boehringer Ingelheim Investigational Site
    • Birmingham, Alabama, United States
      • 1245.25.10121 Boehringer Ingelheim Investigational Site
    • Huntsville, Alabama, United States
      • 1245.25.10037 Boehringer Ingelheim Investigational Site
    • Mobile, Alabama, United States
      • 1245.25.10124 Boehringer Ingelheim Investigational Site
  • Alaska
    • Little Rock, Alaska, United States
      • 1245.25.10015 Boehringer Ingelheim Investigational Site
  • Arizona
    • Gilbert, Arizona, United States
      • 1245.25.10056 Boehringer Ingelheim Investigational Site
    • Peoria, Arizona, United States
      • 1245.25.10175 Boehringer Ingelheim Investigational Site
    • Phoenix, Arizona, United States
      • 1245.25.10072 Boehringer Ingelheim Investigational Site
  • Arkansas
    • Harrisburg, Arkansas, United States
      • 1245.25.10048 Boehringer Ingelheim Investigational Site
  • California
    • Anaheim, California, United States
      • 1245.25.10035 Boehringer Ingelheim Investigational Site
    • Encino, California, United States
      • 1245.25.10103 Boehringer Ingelheim Investigational Site
    • Fresno, California, United States
      • 1245.25.10158 Boehringer Ingelheim Investigational Site
    • Harbor City, California, United States
      • 1245.25.10126 Boehringer Ingelheim Investigational Site
    • Huntington Park, California, United States
      • 1245.25.10058 Boehringer Ingelheim Investigational Site
    • Lancaster, California, United States
      • 1245.25.10001 Boehringer Ingelheim Investigational Site
    • Los Angeles, California, United States
      • 1245.25.10102 Boehringer Ingelheim Investigational Site
    • Los Gatos, California, United States
      • 1245.25.10047 Boehringer Ingelheim Investigational Site
    • Palm Springs, California, United States
      • 1245.25.10118 Boehringer Ingelheim Investigational Site
    • Riverside, California, United States
      • 1245.25.10061 Boehringer Ingelheim Investigational Site
    • San Diego, California, United States
      • 1245.25.10040 Boehringer Ingelheim Investigational Site
    • San Diego, California, United States
      • 1245.25.10055 Boehringer Ingelheim Investigational Site
    • San Diego, California, United States
      • 1245.25.10193 Boehringer Ingelheim Investigational Site
    • Santa Rosa, California, United States
      • 1245.25.10027 Boehringer Ingelheim Investigational Site
    • Stockton, California, United States
      • 1245.25.10074 Boehringer Ingelheim Investigational Site
    • Valencia, California, United States
      • 1245.25.10083 Boehringer Ingelheim Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States
      • 1245.25.10144 Boehringer Ingelheim Investigational Site
    • Denver, Colorado, United States
      • 1245.25.10085 Boehringer Ingelheim Investigational Site
    • Denver, Colorado, United States
      • 1245.25.10153 Boehringer Ingelheim Investigational Site
  • Connecticut
    • Norwalk, Connecticut, United States
      • 1245.25.10066 Boehringer Ingelheim Investigational Site
    • Waterbury, Connecticut, United States
      • 1245.25.10038 Boehringer Ingelheim Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States
      • 1245.25.10068 Boehringer Ingelheim Investigational Site
  • Florida
    • Bradenton, Florida, United States
      • 1245.25.10094 Boehringer Ingelheim Investigational Site
    • Brooksville, Florida, United States
      • 1245.25.10190 Boehringer Ingelheim Investigational Site
    • Clearwater, Florida, United States
      • 1245.25.10209 Boehringer Ingelheim Investigational Site
    • Cooper City, Florida, United States
      • 1245.25.10212 Boehringer Ingelheim Investigational Site
    • Delray Beach, Florida, United States
      • 1245.25.10200 Boehringer Ingelheim Investigational Site
    • Ft. Lauderdale, Florida, United States
      • 1245.25.10033 Boehringer Ingelheim Investigational Site
    • Hallandale Beach, Florida, United States
      • 1245.25.10202 Boehringer Ingelheim Investigational Site
    • Hialeah, Florida, United States
      • 1245.25.10062 Boehringer Ingelheim Investigational Site
    • Hialeah, Florida, United States
      • 1245.25.10063 Boehringer Ingelheim Investigational Site
    • Hialeah, Florida, United States
      • 1245.25.10157 Boehringer Ingelheim Investigational Site
    • Jacksonville, Florida, United States
      • 1245.25.10089 Boehringer Ingelheim Investigational Site
    • Longwood, Florida, United States
      • 1245.25.10019 Boehringer Ingelheim Investigational Site
    • Maitland, Florida, United States
      • 1245.25.10168 Boehringer Ingelheim Investigational Site
    • Miami, Florida, United States
      • 1245.25.10018 Boehringer Ingelheim Investigational Site
    • Miami, Florida, United States
      • 1245.25.10039 Boehringer Ingelheim Investigational Site
    • Miami, Florida, United States
      • 1245.25.10184 Boehringer Ingelheim Investigational Site
    • Orlando, Florida, United States
      • 1245.25.10123 Boehringer Ingelheim Investigational Site
    • Orlando, Florida, United States
      • 1245.25.10201 Boehringer Ingelheim Investigational Site
    • Pembroke Pines, Florida, United States
      • 1245.25.10025 Boehringer Ingelheim Investigational Site
    • Pembroke Pines, Florida, United States
      • 1245.25.10042 Boehringer Ingelheim Investigational Site
    • Port Charlotte, Florida, United States
      • 1245.25.10147 Boehringer Ingelheim Investigational Site
    • Saint Petersburg, Florida, United States
      • 1245.25.10198 Boehringer Ingelheim Investigational Site
    • Saint Petersburg, Florida, United States
      • 1245.25.10203 Boehringer Ingelheim Investigational Site
    • Tampa, Florida, United States
      • 1245.25.10104 Boehringer Ingelheim Investigational Site
    • Tampa, Florida, United States
      • 1245.25.10178 Boehringer Ingelheim Investigational Site
    • Tampa, Florida, United States
      • 1245.25.10211 Boehringer Ingelheim Investigational Site
  • Georgia
    • Atlanta, Georgia, United States
      • 1245.25.10023 Boehringer Ingelheim Investigational Site
    • Columbus, Georgia, United States
      • 1245.25.10174 Boehringer Ingelheim Investigational Site
    • Riverdale, Georgia, United States
      • 1245.25.10141 Boehringer Ingelheim Investigational Site
    • Roswell, Georgia, United States
      • 1245.25.10067 Boehringer Ingelheim Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States
      • 1245.25.10022 Boehringer Ingelheim Investigational Site
  • Idaho
    • Boise, Idaho, United States
      • 1245.25.10092 Boehringer Ingelheim Investigational Site
  • Illinois
    • Chicago, Illinois, United States
      • 1245.25.10097 Boehringer Ingelheim Investigational Site
  • Indiana
    • Evansville, Indiana, United States
      • 1245.25.10116 Boehringer Ingelheim Investigational Site
    • Valparaiso, Indiana, United States
      • 1245.25.10206 Boehringer Ingelheim Investigational Site
  • Kansas
    • Wichita, Kansas, United States
      • 1245.25.10021 Boehringer Ingelheim Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States
      • 1245.25.10186 Boehringer Ingelheim Investigational Site
    • Louisville, Kentucky, United States
      • 1245.25.10109 Boehringer Ingelheim Investigational Site
    • Madisonville, Kentucky, United States
      • 1245.25.10006 Boehringer Ingelheim Investigational Site
    • Paducah, Kentucky, United States
      • 1245.25.10005 Boehringer Ingelheim Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States
      • 1245.25.10020 Boehringer Ingelheim Investigational Site
  • Maine
    • Auburn, Maine, United States
      • 1245.25.10012 Boehringer Ingelheim Investigational Site
  • Maryland
    • Baltimore, Maryland, United States
      • 1245.25.10041 Boehringer Ingelheim Investigational Site
    • Hyattsville, Maryland, United States
      • 1245.25.10134 Boehringer Ingelheim Investigational Site
    • Towson, Maryland, United States
      • 1245.25.10210 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • Springfield, Massachusetts, United States
      • 1245.25.10064 Boehringer Ingelheim Investigational Site
    • Watertown, Massachusetts, United States
      • 1245.25.10051 Boehringer Ingelheim Investigational Site
  • Michigan
    • Dearborn, Michigan, United States
      • 1245.25.10071 Boehringer Ingelheim Investigational Site
    • Flint, Michigan, United States
      • 1245.25.10013 Boehringer Ingelheim Investigational Site
    • Petoskey, Michigan, United States
      • 1245.25.10107 Boehringer Ingelheim Investigational Site
  • Minnesota
    • Eagan, Minnesota, United States
      • 1245.25.10030 Boehringer Ingelheim Investigational Site
    • Minneapolis, Minnesota, United States
      • 1245.25.10028 Boehringer Ingelheim Investigational Site
  • Mississippi
    • Picayune, Mississippi, United States
      • 1245.25.10176 Boehringer Ingelheim Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States
      • 1245.25.10011 Boehringer Ingelheim Investigational Site
    • Kansas City, Missouri, United States
      • 1245.25.10163 Boehringer Ingelheim Investigational Site
  • Montana
    • Great Falls, Montana, United States
      • 1245.25.10148 Boehringer Ingelheim Investigational Site
    • Great Falls, Montana, United States
      • 1245.25.10191 Boehringer Ingelheim Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States
      • 1245.25.10034 Boehringer Ingelheim Investigational Site
  • New Jersey
    • Flemington, New Jersey, United States
      • 1245.25.10014 Boehringer Ingelheim Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • 1245.25.10145 Boehringer Ingelheim Investigational Site
    • Albuquerque, New Mexico, United States
      • 1245.25.10180 Boehringer Ingelheim Investigational Site
  • New York
    • Binghamton, New York, United States
      • 1245.25.10131 Boehringer Ingelheim Investigational Site
    • Rochester, New York, United States
      • 1245.25.10029 Boehringer Ingelheim Investigational Site
    • Smithtown, New York, United States
      • 1245.25.10142 Boehringer Ingelheim Investigational Site
    • Staten Island, New York, United States
      • 1245.25.10096 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Burlington, North Carolina, United States
      • 1245.25.10196 Boehringer Ingelheim Investigational Site
    • Calabash, North Carolina, United States
      • 1245.25.10207 Boehringer Ingelheim Investigational Site
    • Durham, North Carolina, United States
      • 1245.25.10053 Boehringer Ingelheim Investigational Site
    • Greenville, North Carolina, United States
      • 1245.25.10010 Boehringer Ingelheim Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States
      • 1245.25.10060 Boehringer Ingelheim Investigational Site
    • Cincinnati, Ohio, United States
      • 1245.25.10086 Boehringer Ingelheim Investigational Site
    • Dayton, Ohio, United States
      • 1245.25.10137 Boehringer Ingelheim Investigational Site
    • Delaware, Ohio, United States
      • 1245.25.10138 Boehringer Ingelheim Investigational Site
    • Kettering, Ohio, United States
      • 1245.25.10156 Boehringer Ingelheim Investigational Site
    • Marion, Ohio, United States
      • 1245.25.10091 Boehringer Ingelheim Investigational Site
    • Zanesville, Ohio, United States
      • 1245.25.10192 Boehringer Ingelheim Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States
      • 1245.25.10114 Boehringer Ingelheim Investigational Site
  • Oregon
    • Eugene, Oregon, United States
      • 1245.25.10082 Boehringer Ingelheim Investigational Site
  • Pennsylvania
    • Clairton, Pennsylvania, United States
      • 1245.25.10154 Boehringer Ingelheim Investigational Site
    • Clairton, Pennsylvania, United States
      • 1245.25.10173 Boehringer Ingelheim Investigational Site
    • Feasterville Trevose, Pennsylvania, United States
      • 1245.25.10052 Boehringer Ingelheim Investigational Site
    • Fleetwood, Pennsylvania, United States
      • 1245.25.10069 Boehringer Ingelheim Investigational Site
    • Greensburg, Pennsylvania, United States
      • 1245.25.10172 Boehringer Ingelheim Investigational Site
    • Indiana, Pennsylvania, United States
      • 1245.25.10050 Boehringer Ingelheim Investigational Site
    • Lansdale, Pennsylvania, United States
      • 1245.25.10009 Boehringer Ingelheim Investigational Site
    • Philadelphia, Pennsylvania, United States
      • 1245.25.10214 Boehringer Ingelheim Investigational Site
    • Pittsburgh, Pennsylvania, United States
      • 1245.25.10149 Boehringer Ingelheim Investigational Site
    • Pittsburgh, Pennsylvania, United States
      • 1245.25.10197 Boehringer Ingelheim Investigational Site
    • Scottdale, Pennsylvania, United States
      • 1245.25.10159 Boehringer Ingelheim Investigational Site
    • Tipton, Pennsylvania, United States
      • 1245.25.10162 Boehringer Ingelheim Investigational Site
    • Uniontown, Pennsylvania, United States
      • 1245.25.10146 Boehringer Ingelheim Investigational Site
    • Yardley, Pennsylvania, United States
      • 1245.25.10077 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States
      • 1245.25.10070 Boehringer Ingelheim Investigational Site
    • Charleston, South Carolina, United States
      • 1245.25.10044 Boehringer Ingelheim Investigational Site
    • Greer, South Carolina, United States
      • 1245.25.10002 Boehringer Ingelheim Investigational Site
    • Hodges, South Carolina, United States
      • 1245.25.10132 Boehringer Ingelheim Investigational Site
    • Mt. Pleasant, South Carolina, United States
      • 1245.25.10140 Boehringer Ingelheim Investigational Site
    • Myrtle Beach, South Carolina, United States
      • 1245.25.10065 Boehringer Ingelheim Investigational Site
    • Myrtle Beach, South Carolina, United States
      • 1245.25.10127 Boehringer Ingelheim Investigational Site
    • North Myrtle Beach, South Carolina, United States
      • 1245.25.10170 Boehringer Ingelheim Investigational Site
    • Spartanburg, South Carolina, United States
      • 1245.25.10129 Boehringer Ingelheim Investigational Site
    • Union, South Carolina, United States
      • 1245.25.10171 Boehringer Ingelheim Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States
      • 1245.25.10054 Boehringer Ingelheim Investigational Site
    • Chattanooga, Tennessee, United States
      • 1245.25.10036 Boehringer Ingelheim Investigational Site
    • Chattanooga, Tennessee, United States
      • 1245.25.10057 Boehringer Ingelheim Investigational Site
    • Kingsport, Tennessee, United States
      • 1245.25.10046 Boehringer Ingelheim Investigational Site
    • Memphis, Tennessee, United States
      • 1245.25.10143 Boehringer Ingelheim Investigational Site
  • Texas
    • Corpus Christi, Texas, United States
      • 1245.25.10075 Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • 1245.25.10007 Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • 1245.25.10026 Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • 1245.25.10100 Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • 1245.25.10165 Boehringer Ingelheim Investigational Site
    • Fort Worth, Texas, United States
      • 1245.25.10169 Boehringer Ingelheim Investigational Site
    • Houston, Texas, United States
      • 1245.25.10003 Boehringer Ingelheim Investigational Site
    • Houston, Texas, United States
      • 1245.25.10125 Boehringer Ingelheim Investigational Site
    • Houston, Texas, United States
      • 1245.25.10189 Boehringer Ingelheim Investigational Site
    • Lubbock, Texas, United States
      • 1245.25.10119 Boehringer Ingelheim Investigational Site
    • New Braunfels, Texas, United States
      • 1245.25.10078 Boehringer Ingelheim Investigational Site
    • Odessa, Texas, United States
      • 1245.25.10076 Boehringer Ingelheim Investigational Site
    • Pearland, Texas, United States
      • 1245.25.10133 Boehringer Ingelheim Investigational Site
    • Plano, Texas, United States
      • 1245.25.10160 Boehringer Ingelheim Investigational Site
    • Richardson, Texas, United States
      • 1245.25.10177 Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • 1245.25.10049 Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • 1245.25.10161 Boehringer Ingelheim Investigational Site
  • Utah
    • Bountiful, Utah, United States
      • 1245.25.10185 Boehringer Ingelheim Investigational Site
    • Draper, Utah, United States
      • 1245.25.10155 Boehringer Ingelheim Investigational Site
    • Midvale, Utah, United States
      • 1245.25.10079 Boehringer Ingelheim Investigational Site
    • Salt Lake City, Utah, United States
      • 1245.25.10080 Boehringer Ingelheim Investigational Site
    • South Ogden, Utah, United States
      • 1245.25.10087 Boehringer Ingelheim Investigational Site
  • Virginia
    • Burke, Virginia, United States
      • 1245.25.10218 Boehringer Ingelheim Investigational Site
    • Norfolk, Virginia, United States
      • 1245.25.10004 Boehringer Ingelheim Investigational Site
    • South Chesterfield, Virginia, United States
      • 1245.25.10111 Boehringer Ingelheim Investigational Site
  • Washington
    • Spokane, Washington, United States
      • 1245.25.10115 Boehringer Ingelheim Investigational Site
    • Spokane, Washington, United States
      • 1245.25.10216 Boehringer Ingelheim Investigational Site
    • Tacoma, Washington, United States
      • 1245.25.10017 Boehringer Ingelheim Investigational Site
    • Walla Walla, Washington, United States
      • 1245.25.10016 Boehringer Ingelheim Investigational Site
  • West Virginia
    • Charleston, West Virginia, United States
      • 1245.25.10187 Boehringer Ingelheim Investigational Site
    • Morgantown, West Virginia, United States
      • 1245.25.10182 Boehringer Ingelheim Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States
      • 1245.25.10098 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
3. Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients
4. Age >= 18 years
5. Body Mass index <= 45 at Visit 1
6. Signed and dated informed consent
7. High cardiovascular risk

Exclusion criteria:

1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
2. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
3. Planned cardiac surgery or angioplasty within 3 months
4. Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Contraindications to background therapy according to the local label
9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus

11. Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
13. Participation in another trial with an investigational drug within 30 days prior to informed consent
14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo tablets matching BI 10773	Drug: Placebo BI 10773 high dose; Placebo tablets identical to BI 10773; Drug: Placebo BI 10773 low dose; Placebo tablets identical to BI 10773
Experimental: BI 10773 low dose; BI 10773 tablets once daily	Drug: BI 10773 low dose; BI 10773 tablets once daily; Drug: Placebo BI 10773 high dose; Placebo tablets identical to BI 10773
Experimental: BI 10773 high dose; BI 10773 tablets once daily	Drug: BI 10773 high dose; BI 10773 tablets once daily; Drug: Placebo BI 10773 low dose; Placebo tablets identical to BI 10773

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.	Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris	The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial. Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years
Percentage of Participants With Silent MI	Silent MI; defined as presence in the ECG of: Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3; Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF); R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect. It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement. Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years
Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)	Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years
Percentage of Participants With New Onset Albuminuria	New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g. Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years
Percentage of Participants With New Onset Macroalbuminuria	New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years
Percentage of Participants With the Composite Microvascular Outcome	Composite microvascular outcome defined as: Initiation of retinal photocoagulation; Vitreous haemorrhage; Diabetes-related blindness, or; New or worsening nephropathy defined as:New onset of macroalbuminuria; orDoubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; orInitiation of continuous renal replacement therapy, orDeath due to renal disease. Percentage of patients with the event are presented.	From randomisation to individual end of observation, up to 4.6 years

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company

Publications and helpful links

General Publications

• Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
• Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.
• Kahl S, Ofstad AP, Zinman B, Wanner C, Schuler E, Sattar N, Inzucchi SE, Roden M. Effects of empagliflozin on markers of liver steatosis and fibrosis and their relationship to cardiorenal outcomes. Diabetes Obes Metab. 2022 Jun;24(6):1061-1071. doi: 10.1111/dom.14670. Epub 2022 Mar 8.
• Ruggenenti P, Kraus BJ, Inzucchi SE, Zinman B, Hantel S, Mattheus M, von Eynatten M, Remuzzi G, Koitka-Weber A, Wanner C. Nephrotic-range proteinuria in type 2 diabetes: Effects of empagliflozin on kidney disease progression and clinical outcomes. EClinicalMedicine. 2021 Dec 24;43:101240. doi: 10.1016/j.eclinm.2021.101240. eCollection 2022 Jan.
• Reifsnider OS, Kansal AR, Wanner C, Pfarr E, Koitka-Weber A, Brand SB, Stargardter M, Wang C, Kuti E, Ustyugova A. Cost-Effectiveness of Empagliflozin in Patients With Diabetic Kidney Disease in the United States: Findings Based on the EMPA-REG OUTCOME Trial. Am J Kidney Dis. 2022 Jun;79(6):796-806. doi: 10.1053/j.ajkd.2021.09.014. Epub 2021 Nov 6.
• Ferreira JP, Inzucchi SE, Mattheus M, Meinicke T, Steubl D, Wanner C, Zinman B. Empagliflozin and uric acid metabolism in diabetes: A post hoc analysis of the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2022 Jan;24(1):135-141. doi: 10.1111/dom.14559. Epub 2021 Oct 4.
• Vaduganathan M, Inzucchi SE, Sattar N, Fitchett DH, Ofstad AP, Brueckmann M, George JT, Verma S, Mattheus M, Wanner C, Zinman B, Butler J. Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2021 Dec;23(12):2775-2784. doi: 10.1111/dom.14535. Epub 2021 Oct 7.
• Sharma A, Ofstad AP, Ahmad T, Zinman B, Zwiener I, Fitchett D, Wanner C, George JT, Hantel S, Desai N, Mentz RJ. Patient Phenotypes and SGLT-2 Inhibition in Type 2 Diabetes: Insights From the EMPA-REG OUTCOME Trial. JACC Heart Fail. 2021 Aug;9(8):568-577. doi: 10.1016/j.jchf.2021.03.003.
• Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.
• Ferreira JP, Kraus BJ, Zwiener I, Lauer S, Zinman B, Fitchett DH, Koitka-Weber A, George JT, Ofstad AP, Wanner C, Zannad F. Cardio/Kidney Composite End Points: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e020053. doi: 10.1161/JAHA.120.020053. Epub 2021 Mar 23.
• Ferreira JP, Verma S, Fitchett D, Ofstad AP, Lauer S, Zwiener I, George J, Wanner C, Zinman B, Inzucchi SE. Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Nov 26;19(1):200. doi: 10.1186/s12933-020-01174-6.
• McGuire DK, Zinman B, Inzucchi SE, Wanner C, Fitchett D, Anker SD, Pocock S, Kaspers S, George JT, von Eynatten M, Johansen OE, Jamal W, Mattheus M, Elsasser U, Hantel S, Lund SS. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial. Lancet Diabetes Endocrinol. 2020 Dec;8(12):949-959. doi: 10.1016/S2213-8587(20)30344-2.
• Ceriello A, Ofstad AP, Zwiener I, Kaspers S, George J, Nicolucci A. Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Oct 13;19(1):176. doi: 10.1186/s12933-020-01147-9.
• Neeland IJ, Eliasson B, Kasai T, Marx N, Zinman B, Inzucchi SE, Wanner C, Zwiener I, Wojeck BS, Yaggi HK, Johansen OE; EMPA-REG OUTCOME Investigators. The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2020 Dec;43(12):3007-3015. doi: 10.2337/dc20-1096. Epub 2020 Oct 1.
• Levin A, Perkovic V, Wheeler DC, Hantel S, George JT, von Eynatten M, Koitka-Weber A, Wanner C; EMPA-REG OUTCOME Investigators. Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. Clin J Am Soc Nephrol. 2020 Oct 7;15(10):1433-1444. doi: 10.2215/CJN.14901219. Epub 2020 Sep 29.
• Waijer SW, Xie D, Inzucchi SE, Zinman B, Koitka-Weber A, Mattheus M, von Eynatten M, Inker LA, Wanner C, Heerspink HJL. Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2020 Sep 15;9(18):e016976. doi: 10.1161/JAHA.120.016976. Epub 2020 Sep 6.
• Bohm M, Fitchett D, Ofstad AP, Brueckmann M, Kaspers S, George JT, Zwiener I, Zinman B, Wanner C, Marx N, Mancia G, Anker SD, Mahfoud F. Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME. J Hypertens. 2020 Sep;38(9):1829-1840. doi: 10.1097/HJH.0000000000002492.
• Inzucchi SE, Khunti K, Fitchett DH, Wanner C, Mattheus M, George JT, Ofstad AP, Zinman B. Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9):3025-35. doi: 10.1210/clinem/dgaa321.
• Ferreira JP, Fitchett D, Ofstad AP, Kraus BJ, Wanner C, Zwiener I, Zinman B, Lauer S, George JT, Rossignol P, Zannad F. Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. Am J Hypertens. 2020 Dec 31;33(12):1092-1101. doi: 10.1093/ajh/hpaa073.
• Perkovic V, Koitka-Weber A, Cooper ME, Schernthaner G, Pfarr E, Woerle HJ, von Eynatten M, Wanner C. Choice of endpoint in kidney outcome trials: considerations from the EMPA-REG OUTCOME(R) trial. Nephrol Dial Transplant. 2020 Dec 4;35(12):2103-2111. doi: 10.1093/ndt/gfz179.
• Kansal A, Reifsnider OS, Proskorovsky I, Zheng Y, Pfarr E, George JT, Kandaswamy P, Ruffolo A. Cost-effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial. Diabet Med. 2019 Nov;36(11):1494-1502. doi: 10.1111/dme.14076. Epub 2019 Jul 23.
• Butler J, Zannad F, Fitchett D, Zinman B, Koitka-Weber A, von Eynatten M, Zwiener I, George J, Brueckmann M, Cheung AK, Wanner C. Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure. Circ Heart Fail. 2019 Jun;12(6):e005875. doi: 10.1161/CIRCHEARTFAILURE.118.005875. Epub 2019 Jun 5.
• Verma S, Wanner C, Zwiener I, Ofstad AP, George JT, Fitchett D, Zinman B; EMPA-REG OUTCOME Investigators. Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes. J Am Coll Cardiol. 2019 Jun 4;73(21):2780-2782. doi: 10.1016/j.jacc.2019.03.002. Epub 2019 Mar 15. No abstract available.
• Januzzi J, Ferreira JP, Bohm M, Kaul S, Wanner C, Brueckmann M, Petrie MC, Ofstad AP, Zeller C, George J, Fitchett D, Zannad F. Empagliflozin reduces the risk of a broad spectrum of heart failure outcomes regardless of heart failure status at baseline. Eur J Heart Fail. 2019 Mar;21(3):386-388. doi: 10.1002/ejhf.1419. Epub 2019 Feb 14. No abstract available.
• Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778.
• Verma S, Mazer CD, Fitchett D, Inzucchi SE, Pfarr E, George JT, Zinman B. Empagliflozin reduces cardiovascular events, mortality and renal events in participants with type 2 diabetes after coronary artery bypass graft surgery: subanalysis of the EMPA-REG OUTCOME(R) randomised trial. Diabetologia. 2018 Aug;61(8):1712-1723. doi: 10.1007/s00125-018-4644-9. Epub 2018 May 19.
• Inzucchi SE, Zinman B, Fitchett D, Wanner C, Ferrannini E, Schumacher M, Schmoor C, Ohneberg K, Johansen OE, George JT, Hantel S, Bluhmki E, Lachin JM. How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2018 Feb;41(2):356-363. doi: 10.2337/dc17-1096. Epub 2017 Dec 4.
• Wanner C, Lachin JM, Inzucchi SE, Fitchett D, Mattheus M, George J, Woerle HJ, Broedl UC, von Eynatten M, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus, Established Cardiovascular Disease, and Chronic Kidney Disease. Circulation. 2018 Jan 9;137(2):119-129. doi: 10.1161/CIRCULATIONAHA.117.028268. Epub 2017 Sep 13.
• Cherney DZI, Zinman B, Inzucchi SE, Koitka-Weber A, Mattheus M, von Eynatten M, Wanner C. Effects of empagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: an exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Aug;5(8):610-621. doi: 10.1016/S2213-8587(17)30182-1. Epub 2017 Jun 27.
• Zinman B, Inzucchi SE, Lachin JM, Wanner C, Fitchett D, Kohler S, Mattheus M, Woerle HJ, Broedl UC, Johansen OE, Albers GW, Diener HC; EMPA-REG OUTCOME Investigators (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. Stroke. 2017 May;48(5):1218-1225. doi: 10.1161/STROKEAHA.116.015756. Epub 2017 Apr 6.
• Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.
• Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
• Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, Bluhmki E, Hantel S, Kempthorne-Rawson J, Newman J, Johansen OE, Woerle HJ, Broedl UC. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME). Cardiovasc Diabetol. 2014 Jun 19;13:102. doi: 10.1186/1475-2840-13-102.

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Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

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Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1245.25; 2009-016178-33 (EudraCT Number: EudraCT)