Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: BI 10773; Drug: Placebo; Drug: Sitagliptin 100mg

• Study Type: Interventional
• Enrollment (Actual): 2705
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • 1245.31.32008 Boehringer Ingelheim Investigational Site
  • Bruxelles, Belgium
    • 1245.31.32023 Boehringer Ingelheim Investigational Site
  • De Pinte, Belgium
    • 1245.31.32003 Boehringer Ingelheim Investigational Site
  • Deurne, Belgium
    • 1245.31.32015 Boehringer Ingelheim Investigational Site
  • Deurne, Belgium
    • 1245.31.32016 Boehringer Ingelheim Investigational Site
  • Gozée, Belgium
    • 1245.31.32025 Boehringer Ingelheim Investigational Site
  • Leopoldsburg, Belgium
    • 1245.31.32019 Boehringer Ingelheim Investigational Site
  • Linkebeek, Belgium
    • 1245.31.32024 Boehringer Ingelheim Investigational Site
  • Mouscron, Belgium
    • 1245.31.32021 Boehringer Ingelheim Investigational Site
  • Sint-Gillis-Waas, Belgium
    • 1245.31.32020 Boehringer Ingelheim Investigational Site
  • Tielt, Belgium
    • 1245.31.32018 Boehringer Ingelheim Investigational Site
  • Tremelo, Belgium
    • 1245.31.32026 Boehringer Ingelheim Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • 1245.31.20032 Boehringer Ingelheim Investigational Site
    • Edmonton, Alberta, Canada
      • 1245.31.20023 Boehringer Ingelheim Investigational Site
  • British Columbia
    • Chilliwack, British Columbia, Canada
      • 1245.31.20011 Boehringer Ingelheim Investigational Site
    • Vancouver, British Columbia, Canada
      • 1245.31.20028 Boehringer Ingelheim Investigational Site
    • Victoria, British Columbia, Canada
      • 1245.31.20018 Boehringer Ingelheim Investigational Site
    • Victoria, British Columbia, Canada
      • 1245.31.20033 Boehringer Ingelheim Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • 1245.31.20015 Boehringer Ingelheim Investigational Site
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • 1245.31.20012 Boehringer Ingelheim Investigational Site
  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada
      • 1245.31.20016 Boehringer Ingelheim Investigational Site
    • Paradise, Newfoundland and Labrador, Canada
      • 1245.31.20024 Boehringer Ingelheim Investigational Site
    • St. John's, Newfoundland and Labrador, Canada
      • 1245.31.20008 Boehringer Ingelheim Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • 1245.31.20026 Boehringer Ingelheim Investigational Site
  • Ontario
    • Brampton, Ontario, Canada
      • 1245.31.20022 Boehringer Ingelheim Investigational Site
    • Brampton, Ontario, Canada
      • 1245.31.20057 Boehringer Ingelheim Investigational Site
    • Corunna, Ontario, Canada
      • 1245.31.20035 Boehringer Ingelheim Investigational Site
    • Etobicoke, Ontario, Canada
      • 1245.31.20030 Boehringer Ingelheim Investigational Site
    • Hamilton, Ontario, Canada
      • 1245.31.20019 Boehringer Ingelheim Investigational Site
    • London, Ontario, Canada
      • 1245.31.20017 Boehringer Ingelheim Investigational Site
    • London, Ontario, Canada
      • 1245.31.20029 Boehringer Ingelheim Investigational Site
    • London, Ontario, Canada
      • 1245.31.20060 Boehringer Ingelheim Investigational Site
    • Markham, Ontario, Canada
      • 1245.31.20003 Boehringer Ingelheim Investigational Site
    • Newmarket, Ontario, Canada
      • 1245.31.20009 Boehringer Ingelheim Investigational Site
    • Oakville, Ontario, Canada
      • 1245.31.20040 Boehringer Ingelheim Investigational Site
    • Sarnia, Ontario, Canada
      • 1245.31.20034 Boehringer Ingelheim Investigational Site
    • Strathroy, Ontario, Canada
      • 1245.31.20005 Boehringer Ingelheim Investigational Site
    • Toronto, Ontario, Canada
      • 1245.31.20002 Boehringer Ingelheim Investigational Site
    • Toronto, Ontario, Canada
      • 1245.31.20006 Boehringer Ingelheim Investigational Site
  • Prince Edward Island
    • Montague, Prince Edward Island, Canada
      • 1245.31.20007 Boehringer Ingelheim Investigational Site
  • Quebec
    • Laval, Quebec, Canada
      • 1245.31.20027 Boehringer Ingelheim Investigational Site
    • Montreal, Quebec, Canada
      • 1245.31.20025 Boehringer Ingelheim Investigational Site
    • Sherbrooke, Quebec, Canada
      • 1245.31.20036 Boehringer Ingelheim Investigational Site
    • St-Romuald, Quebec, Canada
      • 1245.31.20058 Boehringer Ingelheim Investigational Site
    • Trois Rivieres, Quebec, Canada
      • 1245.31.20021 Boehringer Ingelheim Investigational Site
    • Ville Saint-Laurent, Quebec, Canada
      • 1245.31.20038 Boehringer Ingelheim Investigational Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • 1245.31.20041 Boehringer Ingelheim Investigational Site
• China
  • Beijing, China
    • 1245.31.86007 Boehringer Ingelheim Investigational Site
  • Beijing, China
    • 1245.31.86008 Boehringer Ingelheim Investigational Site
  • Beijing, China
    • 1245.31.86031 Boehringer Ingelheim Investigational Site
  • Beijing, China
    • 1245.31.86032 Boehringer Ingelheim Investigational Site
  • Beijing, China
    • 1245.31.86033 Boehringer Ingelheim Investigational Site
  • Beijing, China
    • 1245.31.86034 Boehringer Ingelheim Investigational Site
  • Beijing, China
    • 1245.31.86035 Boehringer Ingelheim Investigational Site
  • Chongqing, China
    • 1245.31.86058 Boehringer Ingelheim Investigational Site
  • Dalian, China
    • 1245.31.86038 Boehringer Ingelheim Investigational Site
  • Guangzhou, China
    • 1245.31.86001 Boehringer Ingelheim Investigational Site
  • Guangzhou, China
    • 1245.31.86003 Boehringer Ingelheim Investigational Site
  • Guangzhou, China
    • 1245.31.86052 Boehringer Ingelheim Investigational Site
  • Guiyang, China
    • 1245.31.86012 Boehringer Ingelheim Investigational Site
  • Haerbin, China
    • 1245.31.86037 Boehringer Ingelheim Investigational Site
  • Hangzhou, China
    • 1245.31.86020 Boehringer Ingelheim Investigational Site
  • Jinan, China
    • 1245.31.86049 Boehringer Ingelheim Investigational Site
  • Jinan, China
    • 1245.31.86053 Boehringer Ingelheim Investigational Site
  • Jingzhou, China
    • 1245.31.86018 Boehringer Ingelheim Investigational Site
  • Nan Ning, China
    • 1245.31.86055 Boehringer Ingelheim Investigational Site
  • Nan Ning, China
    • 1245.31.86056 Boehringer Ingelheim Investigational Site
  • Nanchang, China
    • 1245.31.86019 Boehringer Ingelheim Investigational Site
  • Nanjing, China
    • 1245.31.86042 Boehringer Ingelheim Investigational Site
  • Nanjing, China
    • 1245.31.86043 Boehringer Ingelheim Investigational Site
  • QingDao, China
    • 1245.31.86016 Boehringer Ingelheim Investigational Site
  • Shanghai, China
    • 1245.31.86039 Boehringer Ingelheim Investigational Site
  • Shantou, China
    • 1245.31.86054 Boehringer Ingelheim Investigational Site
  • Shenyang, China
    • 1245.31.86057 Boehringer Ingelheim Investigational Site
  • Shijiazhuang, China
    • 1245.31.86045 Boehringer Ingelheim Investigational Site
  • Shiyan, China
    • 1245.31.86017 Boehringer Ingelheim Investigational Site
  • Suzhou, China
    • 1245.31.86013 Boehringer Ingelheim Investigational Site
  • Taiyuan, China
    • 1245.31.86015 Boehringer Ingelheim Investigational Site
  • Tianjin, China
    • 1245.31.86036 Boehringer Ingelheim Investigational Site
  • Xi'An, China
    • 1245.31.86011 Boehringer Ingelheim Investigational Site
  • Xi'An, China
    • 1245.31.86041 Boehringer Ingelheim Investigational Site
  • Xiamen, China
    • 1245.31.86014 Boehringer Ingelheim Investigational Site
• France
  • Bersée, France
    • 1245.31.33008 Boehringer Ingelheim Investigational Site
  • Bischheim, France
    • 1245.31.33020 Boehringer Ingelheim Investigational Site
  • Bondy Cedex, France
    • 1245.31.33002 Boehringer Ingelheim Investigational Site
  • Bruay La Buissiere, France
    • 1245.31.33016 Boehringer Ingelheim Investigational Site
  • Corbeil Essonnes, France
    • 1245.31.33001 Boehringer Ingelheim Investigational Site
  • Croix, France
    • 1245.31.33010 Boehringer Ingelheim Investigational Site
  • Hautmont, France
    • 1245.31.33009 Boehringer Ingelheim Investigational Site
  • La Rochelle Cedex 1, France
    • 1245.31.33003 Boehringer Ingelheim Investigational Site
  • Marseille, France
    • 1245.31.33045 Boehringer Ingelheim Investigational Site
  • Narbonne Cedex, France
    • 1245.31.33004 Boehringer Ingelheim Investigational Site
  • Schiltigheim, France
    • 1245.31.33012 Boehringer Ingelheim Investigational Site
  • Strasbourg, France
    • 1245.31.33013 Boehringer Ingelheim Investigational Site
  • Strasbourg, France
    • 1245.31.33019 Boehringer Ingelheim Investigational Site
  • Vieux Condé, France
    • 1245.31.33007 Boehringer Ingelheim Investigational Site
  • Wattrelos, France
    • 1245.31.33018 Boehringer Ingelheim Investigational Site
• Germany
  • Dormagen, Germany
    • 1245.31.49001 Boehringer Ingelheim Investigational Site
  • Dresden, Germany
    • 1245.31.49013 Boehringer Ingelheim Investigational Site
  • Düsseldorf, Germany
    • 1245.31.49016 Boehringer Ingelheim Investigational Site
  • Flörsheim, Germany
    • 1245.31.49009 Boehringer Ingelheim Investigational Site
  • Frankfurt, Germany
    • 1245.31.49015 Boehringer Ingelheim Investigational Site
  • Haag, Germany
    • 1245.31.49019 Boehringer Ingelheim Investigational Site
  • Hatten, Germany
    • 1245.31.49004 Boehringer Ingelheim Investigational Site
  • Hohenmölsen, Germany
    • 1245.31.49020 Boehringer Ingelheim Investigational Site
  • Künzing, Germany
    • 1245.31.49007 Boehringer Ingelheim Investigational Site
  • Neuwied, Germany
    • 1245.31.49002 Boehringer Ingelheim Investigational Site
  • Nürnberg, Germany
    • 1245.31.49008 Boehringer Ingelheim Investigational Site
  • Rednitzhembach, Germany
    • 1245.31.49010 Boehringer Ingelheim Investigational Site
  • Rehburg-Loccum, Germany
    • 1245.31.49006 Boehringer Ingelheim Investigational Site
  • Rehlingen-Siersburg, Germany
    • 1245.31.49011 Boehringer Ingelheim Investigational Site
  • Saarbrücken, Germany
    • 1245.31.49005 Boehringer Ingelheim Investigational Site
  • Schauenburg, Germany
    • 1245.31.49022 Boehringer Ingelheim Investigational Site
  • St. Ingbert/Oberwürzbach, Germany
    • 1245.31.49017 Boehringer Ingelheim Investigational Site
  • Unterschneidheim, Germany
    • 1245.31.49003 Boehringer Ingelheim Investigational Site
• Greece
  • Thessaloniki, Greece
    • 1245.31.30004 Boehringer Ingelheim Investigational Site
• India
  • Bangalore, India
    • 1245.31.91005 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.31.91006 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.31.91008 Boehringer Ingelheim Investigational Site
  • Belgaum, India
    • 1245.31.91003 Boehringer Ingelheim Investigational Site
  • Chennai, India
    • 1245.31.91004 Boehringer Ingelheim Investigational Site
  • Chennai, India
    • 1245.31.91009 Boehringer Ingelheim Investigational Site
  • Coimbatore, India
    • 1245.31.91001 Boehringer Ingelheim Investigational Site
  • Coimbatore, India
    • 1245.31.91101 Boehringer Ingelheim Investigational Site
  • Gulbarga, India
    • 1245.31.91015 Boehringer Ingelheim Investigational Site
  • Indore, India
    • 1245.31.91104 Boehringer Ingelheim Investigational Site
  • Maharashtra, India
    • 1245.31.91103 Boehringer Ingelheim Investigational Site
  • Mumbai, India
    • 1245.31.91002 Boehringer Ingelheim Investigational Site
  • Mumbai, Maharastra, India
    • 1245.31.91007 Boehringer Ingelheim Investigational Site
  • Nagpur, India
    • 1245.31.91010 Boehringer Ingelheim Investigational Site
  • New Delhi, India
    • 1245.31.91012 Boehringer Ingelheim Investigational Site
  • Pune, India
    • 1245.31.91014 Boehringer Ingelheim Investigational Site
  • Pune, India
    • 1245.31.91105 Boehringer Ingelheim Investigational Site
• Ireland
  • Birr, Co. Offaly, Ireland
    • 1245.31.35304 Boehringer Ingelheim Investigational Site
  • Co. Cork, Ireland
    • 1245.31.35302 Boehringer Ingelheim Investigational Site
  • Co. Galway, Ireland
    • 1245.31.35305 Boehringer Ingelheim Investigational Site
  • Co. Wexford, Ireland
    • 1245.31.35303 Boehringer Ingelheim Investigational Site
  • Co. Wexford, Ireland
    • 1245.31.35306 Boehringer Ingelheim Investigational Site
• Japan
  • Chiyoda-ku, Tokyo, Japan
    • 1245.31.81007 Boehringer Ingelheim Investigational Site
  • Chuo-ku, Tokyo, Japan
    • 1245.31.81001 Boehringer Ingelheim Investigational Site
  • Chuo-ku, Tokyo, Japan
    • 1245.31.81002 Boehringer Ingelheim Investigational Site
  • Ebetsu, Hokkaido, Japan
    • 1245.31.81005 Boehringer Ingelheim Investigational Site
  • Kamakura, Kanagawa, Japan
    • 1245.31.81004 Boehringer Ingelheim Investigational Site
  • Minato-ku, Tokyo, Japan
    • 1245.31.81003 Boehringer Ingelheim Investigational Site
  • Shinjuku-ku, Tokyo, Japan
    • 1245.31.81006 Boehringer Ingelheim Investigational Site
  • Shinjuku-ku, Tokyo, Japan
    • 1245.31.81008 Boehringer Ingelheim Investigational Site
  • Suita, Osaka, Japan
    • 1245.31.81009 Boehringer Ingelheim Investigational Site
  • Ube, Yamaguchi, Japan
    • 1245.31.81010 Boehringer Ingelheim Investigational Site
  • Urasoe, Okinawa, Japan
    • 1245.31.81012 Boehringer Ingelheim Investigational Site
  • Urasoe, Okinawa, Japan
    • 1245.31.81013 Boehringer Ingelheim Investigational Site
• Korea, Republic of
  • Anyang, Korea, Republic of
    • 1245.31.82012 Boehringer Ingelheim Investigational Site
  • Goyang, Korea, Republic of
    • 1245.31.82011 Boehringer Ingelheim Investigational Site
  • Ilsan, Korea, Republic of
    • 1245.31.82009 Boehringer Ingelheim Investigational Site
  • Incheon, Korea, Republic of
    • 1245.31.82001 Boehringer Ingelheim Investigational Site
  • Jeonju, Korea, Republic of
    • 1245.31.82006 Boehringer Ingelheim Investigational Site
  • Pusan, Korea, Republic of
    • 1245.31.82004 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.31.82005 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.31.82007 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.31.82008 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.31.82010 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1245.31.82014 Boehringer Ingelheim Investigational Site
  • Suwon, Korea, Republic of
    • 1245.31.82002 Boehringer Ingelheim Investigational Site
  • Wonju, Korea, Republic of
    • 1245.31.82003 Boehringer Ingelheim Investigational Site
• Mexico
  • Guadalajara, Mexico
    • 1245.31.52003 Boehringer Ingelheim Investigational Site
  • Guadalajara, Mexico
    • 1245.31.52004 Boehringer Ingelheim Investigational Site
  • Monterrey, Mexico
    • 1245.31.52001 Boehringer Ingelheim Investigational Site
  • Monterrey, Mexico
    • 1245.31.52002 Boehringer Ingelheim Investigational Site
• Philippines
  • Cebu, Philippines
    • 1245.31.63002 Boehringer Ingelheim Investigational Site
  • Davao City, Philippines
    • 1245.31.63003 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.31.63001 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.31.63004 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.31.63005 Boehringer Ingelheim Investigational Site
• Slovakia
  • Bratislava, Slovakia
    • 1245.31.74005 Boehringer Ingelheim Investigational Site
  • Lucenec, Slovakia
    • 1245.31.74002 Boehringer Ingelheim Investigational Site
  • Nitra, Slovakia
    • 1245.31.74006 Boehringer Ingelheim Investigational Site
  • Nove Zamky, Slovakia
    • 1245.31.74014 Boehringer Ingelheim Investigational Site
  • Povazska Bystrica, Slovakia
    • 1245.31.74001 Boehringer Ingelheim Investigational Site
  • Presov, Slovakia
    • 1245.31.74004 Boehringer Ingelheim Investigational Site
  • Trebisov, Slovakia
    • 1245.31.74003 Boehringer Ingelheim Investigational Site
• Slovenia
  • Celje, Slovenia
    • 1245.31.38003 Boehringer Ingelheim Investigational Site
  • Koper, Slovenia
    • 1245.31.38002 Boehringer Ingelheim Investigational Site
  • Maribor, Slovenia
    • 1245.31.38001 Boehringer Ingelheim Investigational Site
• Switzerland
  • Lugano, Switzerland
    • 1245.31.41004 Boehringer Ingelheim Investigational Site
  • Rorschach, Switzerland
    • 1245.31.41003 Boehringer Ingelheim Investigational Site
• Taiwan
  • Kaohsiung, Taiwan
    • 1245.31.88010 Boehringer Ingelheim Investigational Site
  • Kaohsiung, Taiwan
    • 1245.31.88011 Boehringer Ingelheim Investigational Site
  • Kaohsiung, Taiwan
    • 1245.31.88012 Boehringer Ingelheim Investigational Site
  • Kaohsiung, Taiwan
    • 1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan
    • 1245.31.88009 Boehringer Ingelheim Investigational Site
  • Tainan, Taiwan
    • 1245.31.88014 Boehringer Ingelheim Investigational Site
  • Taipei, Taiwan
    • 1245.31.88006 Boehringer Ingelheim Investigational Site
  • Taipei, Taiwan
    • 1245.31.88021 Boehringer Ingelheim Investigational Site
  • Taoyuan County, Taiwan
    • 1245.31.88008 Boehringer Ingelheim Investigational Site
• Turkey
  • Erzurum, Turkey
    • 1245.31.90003 Boehringer Ingelheim Investigational Site
  • Gaziantep, Turkey
    • 1245.31.90001 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1245.31.90002 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1245.31.90006 Boehringer Ingelheim Investigational Site
  • Izmir, Turkey
    • 1245.31.90004 Boehringer Ingelheim Investigational Site
• Ukraine
  • Dnepropetrovsk, Ukraine
    • 1245.31.75002 Boehringer Ingelheim Investigational Site
  • Kharkiv, Ukraine
    • 1245.31.75001 Boehringer Ingelheim Investigational Site
  • Lviv, Ukraine
    • 1245.31.75006 Boehringer Ingelheim Investigational Site
  • Vinnitsa, Ukraine
    • 1245.31.75004 Boehringer Ingelheim Investigational Site
  • Vinnytsya, Ukraine
    • 1245.31.75003 Boehringer Ingelheim Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • 1245.31.10145 Boehringer Ingelheim Investigational Site
  • Arizona
    • Glendale, Arizona, United States
      • 1245.31.10162 Boehringer Ingelheim Investigational Site
    • Mesa, Arizona, United States
      • 1245.31.10124 Boehringer Ingelheim Investigational Site
    • Phoenix, Arizona, United States
      • 1245.31.10108 Boehringer Ingelheim Investigational Site
    • Tempe, Arizona, United States
      • 1245.31.10046 Boehringer Ingelheim Investigational Site
  • California
    • Chino, California, United States
      • 1245.31.10154 Boehringer Ingelheim Investigational Site
    • Rancho Cucamonga, California, United States
      • 1245.31.10149 Boehringer Ingelheim Investigational Site
    • West Hills, California, United States
      • 1245.31.10131 Boehringer Ingelheim Investigational Site
  • Colorado
    • Northglenn, Colorado, United States
      • 1245.31.10038 Boehringer Ingelheim Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States
      • 1245.31.10127 Boehringer Ingelheim Investigational Site
  • Florida
    • Clearwater, Florida, United States
      • 1245.31.10137 Boehringer Ingelheim Investigational Site
    • Jupiter, Florida, United States
      • 1245.31.10133 Boehringer Ingelheim Investigational Site
    • Miami, Florida, United States
      • 1245.31.10006 Boehringer Ingelheim Investigational Site
    • Plantation, Florida, United States
      • 1245.31.10085 Boehringer Ingelheim Investigational Site
  • Georgia
    • Decatur, Georgia, United States
      • 1245.31.10080 Boehringer Ingelheim Investigational Site
    • Perry, Georgia, United States
      • 1245.31.10077 Boehringer Ingelheim Investigational Site
  • Illinois
    • Chicago, Illinois, United States
      • 1245.31.10001 Boehringer Ingelheim Investigational Site
  • Iowa
    • Des Moines, Iowa, United States
      • 1245.31.10159 Boehringer Ingelheim Investigational Site
    • Dubuque, Iowa, United States
      • 1245.31.10014 Boehringer Ingelheim Investigational Site
  • Kansas
    • Arkansas City, Kansas, United States
      • 1245.31.10117 Boehringer Ingelheim Investigational Site
    • Newton, Kansas, United States
      • 1245.31.10157 Boehringer Ingelheim Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States
      • 1245.31.10146 Boehringer Ingelheim Investigational Site
  • Michigan
    • Dearborn, Michigan, United States
      • 1245.31.10003 Boehringer Ingelheim Investigational Site
  • New York
    • New Hyde Park, New York, United States
      • 1245.31.10059 Boehringer Ingelheim Investigational Site
    • Rochester, New York, United States
      • 1245.31.10034 Boehringer Ingelheim Investigational Site
    • Smithtown, New York, United States
      • 1245.31.10123 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Asheboro, North Carolina, United States
      • 1245.31.10071 Boehringer Ingelheim Investigational Site
    • Salisbury, North Carolina, United States
      • 1245.31.10086 Boehringer Ingelheim Investigational Site
  • Ohio
    • Carlisle, Ohio, United States
      • 1245.31.10129 Boehringer Ingelheim Investigational Site
    • Cincinnati, Ohio, United States
      • 1245.31.10045 Boehringer Ingelheim Investigational Site
    • Cincinnati, Ohio, United States
      • 1245.31.10119 Boehringer Ingelheim Investigational Site
    • Gallipolis, Ohio, United States
      • 1245.31.10130 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Mount Pleasant, South Carolina, United States
      • 1245.31.10158 Boehringer Ingelheim Investigational Site
    • Simpsonville, South Carolina, United States
      • 1245.31.10015 Boehringer Ingelheim Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States
      • 1245.31.10033 Boehringer Ingelheim Investigational Site
    • Memphis, Tennessee, United States
      • 1245.31.10112 Boehringer Ingelheim Investigational Site
  • Texas
    • Houston, Texas, United States
      • 1245.31.10156 Boehringer Ingelheim Investigational Site
    • Hurst, Texas, United States
      • 1245.31.10151 Boehringer Ingelheim Investigational Site
    • Killeen, Texas, United States
      • 1245.31.10143 Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • 1245.31.10155 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
3. Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
5. Pre-menopausal women (last menstruation < or = 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 (if acceptable by local authorities), double barrier method and vasectomised partner.
6. 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.
7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 10773 low (drug naive); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Experimental: BI 10773 high (drug naive); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Placebo Comparator: Placebo (drug naive); Placebo tablets matching BI 10773 / Sitagliptin once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: Placebo; Placebo matching Sitagliptin
Active Comparator: Sitagliptin 100mg (drug naive); Sitagliptin once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: Placebo; Placebo matching Sitagliptin; Drug: Sitagliptin 100mg; Sitagliptin once daily
Experimental: BI 10773 low (pioglitazone); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Experimental: BI 10773 high (pioglitazone); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Placebo Comparator: Placebo (pioglitazone); Placebo tablets matching BI 10773 once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: Placebo; Placebo matching Sitagliptin
Experimental: BI 10773 low (metformin); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Experimental: BI 10773 high (metformin); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Placebo Comparator: Placebo (metformin); Placebo tablets matching BI 10773 once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: Placebo; Placebo matching Sitagliptin
Experimental: BI 10773 low (metformin+sulfonylurea); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Experimental: BI 10773 high (metformin+sulfonylurea); BI 10773 tablets once daily	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: BI 10773; BI 10773 tablets once daily; Drug: Placebo; Placebo matching Sitagliptin
Placebo Comparator: Placebo (metformin+sulfonylurea); Placebo tablets matching BI 10773	Drug: Placebo; Placebo matching BI 10773 low dose; Drug: Placebo; Placebo matching BI 10773 high dose; Drug: Placebo; Placebo matching Sitagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks	Baseline and 52 weeks
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment	Change from baseline in HbA1c after 76 weeks	Baseline and 76 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment	Change from baseline in HbA1c (%) after 76 weeks using MMRM approach	Baseline and 76 weeks
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	Systolic blood pressure - change from baseline after 52 weeks of treatment	Baseline and 52 weeks
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	Systolic blood pressure - change from baseline after 76 weeks of treatment	Baseline and 76 weeks
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	Diastolic blood pressure - change from baseline after 52 weeks of treatment	Baseline and 52 weeks
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	Diastolic blood pressure - change from baseline after 76 weeks of treatment	Baseline and 76 weeks
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment	Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment	Baseline and 52 weeks
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment	Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment	Baseline and 76 weeks
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment	Waist circumference (cm) - change from baseline after 52 weeks of treatment	Baseline and 52 weeks
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment	Waist circumference (cm) - change from baseline after 76 weeks of treatment	Baseline and 76 weeks
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment	Fasting plasma glucose - change from baseline after 52 weeks of treatment	Baseline and 52 weeks
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment	Fasting plasma glucose - change from baseline after 76 weeks of treatment	Baseline and 76 weeks

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.
• Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
• Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
• Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.
• Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

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; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Empagliflozin; Sitagliptin Phosphate
• Other Study ID Numbers: 1245.31; 2010-022718-17 (EudraCT Number: EudraCT)