- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01177813
Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Dresden, Alemania
- 1245.20.49013 Boehringer Ingelheim Investigational Site
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Düsseldorf, Alemania
- 1245.20.49016 Boehringer Ingelheim Investigational Site
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Frankfurt, Alemania
- 1245.20.49015 Boehringer Ingelheim Investigational Site
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Haag, Alemania
- 1245.20.49019 Boehringer Ingelheim Investigational Site
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Hohenmölsen, Alemania
- 1245.20.49020 Boehringer Ingelheim Investigational Site
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Köthen, Alemania
- 1245.20.49014 Boehringer Ingelheim Investigational Site
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Neuwied, Alemania
- 1245.20.49002 Boehringer Ingelheim Investigational Site
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Nürnberg, Alemania
- 1245.20.49008 Boehringer Ingelheim Investigational Site
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Schauenburg, Alemania
- 1245.20.49022 Boehringer Ingelheim Investigational Site
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St. Ingbert/Oberwürzbach, Alemania
- 1245.20.49017 Boehringer Ingelheim Investigational Site
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Unterschneidheim, Alemania
- 1245.20.49003 Boehringer Ingelheim Investigational Site
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Bruxelles, Bélgica
- 1245.20.32008 Boehringer Ingelheim Investigational Site
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Bruxelles, Bélgica
- 1245.20.32011 Boehringer Ingelheim Investigational Site
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Bruxelles, Bélgica
- 1245.20.32023 Boehringer Ingelheim Investigational Site
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De Pinte, Bélgica
- 1245.20.32003 Boehringer Ingelheim Investigational Site
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Deurne, Bélgica
- 1245.20.32015 Boehringer Ingelheim Investigational Site
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Deurne, Bélgica
- 1245.20.32016 Boehringer Ingelheim Investigational Site
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Gozée, Bélgica
- 1245.20.32025 Boehringer Ingelheim Investigational Site
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Landen, Bélgica
- 1245.20.32022 Boehringer Ingelheim Investigational Site
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Leopoldsburg, Bélgica
- 1245.20.32019 Boehringer Ingelheim Investigational Site
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Linkebeek, Bélgica
- 1245.20.32024 Boehringer Ingelheim Investigational Site
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Mouscron, Bélgica
- 1245.20.32021 Boehringer Ingelheim Investigational Site
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Retie, Bélgica
- 1245.20.32027 Boehringer Ingelheim Investigational Site
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Sint-Gillis-Waas, Bélgica
- 1245.20.32020 Boehringer Ingelheim Investigational Site
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Tielt, Bélgica
- 1245.20.32018 Boehringer Ingelheim Investigational Site
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Tremelo, Bélgica
- 1245.20.32026 Boehringer Ingelheim Investigational Site
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British Columbia
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Chilliwack, British Columbia, Canadá
- 1245.20.20011 Boehringer Ingelheim Investigational Site
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Victoria, British Columbia, Canadá
- 1245.20.20018 Boehringer Ingelheim Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canadá
- 1245.20.20015 Boehringer Ingelheim Investigational Site
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New Brunswick
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Moncton, New Brunswick, Canadá
- 1245.20.20012 Boehringer Ingelheim Investigational Site
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Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canadá
- 1245.20.20016 Boehringer Ingelheim Investigational Site
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St. John's, Newfoundland and Labrador, Canadá
- 1245.20.20008 Boehringer Ingelheim Investigational Site
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Ontario
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Barrie, Ontario, Canadá
- 1245.20.20001 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canadá
- 1245.20.20019 Boehringer Ingelheim Investigational Site
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London, Ontario, Canadá
- 1245.20.20010 Boehringer Ingelheim Investigational Site
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London, Ontario, Canadá
- 1245.20.20017 Boehringer Ingelheim Investigational Site
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Markham, Ontario, Canadá
- 1245.20.20003 Boehringer Ingelheim Investigational Site
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Newmarket, Ontario, Canadá
- 1245.20.20009 Boehringer Ingelheim Investigational Site
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Ottawa, Ontario, Canadá
- 1245.20.20013 Boehringer Ingelheim Investigational Site
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Strathroy, Ontario, Canadá
- 1245.20.20005 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canadá
- 1245.20.20002 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canadá
- 1245.20.20006 Boehringer Ingelheim Investigational Site
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canadá
- 1245.20.20014 Boehringer Ingelheim Investigational Site
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Montague, Prince Edward Island, Canadá
- 1245.20.20007 Boehringer Ingelheim Investigational Site
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Quebec
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Trois Rivieres, Quebec, Canadá
- 1245.20.20021 Boehringer Ingelheim Investigational Site
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Arizona
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Mesa, Arizona, Estados Unidos
- 1245.20.10124 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, Estados Unidos
- 1245.20.10108 Boehringer Ingelheim Investigational Site
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Arkansas
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Hot Springs, Arkansas, Estados Unidos
- 1245.20.10150 Boehringer Ingelheim Investigational Site
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California
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Chino, California, Estados Unidos
- 1245.20.10154 Boehringer Ingelheim Investigational Site
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Santa Ana, California, Estados Unidos
- 1245.20.10009 Boehringer Ingelheim Investigational Site
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West Hills, California, Estados Unidos
- 1245.20.10131 Boehringer Ingelheim Investigational Site
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Colorado
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Northglenn, Colorado, Estados Unidos
- 1245.20.10038 Boehringer Ingelheim Investigational Site
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Florida
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Clearwater, Florida, Estados Unidos
- 1245.20.10137 Boehringer Ingelheim Investigational Site
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Miami, Florida, Estados Unidos
- 1245.20.10006 Boehringer Ingelheim Investigational Site
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Plantation, Florida, Estados Unidos
- 1245.20.10085 Boehringer Ingelheim Investigational Site
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Tampa, Florida, Estados Unidos
- 1245.20.10078 Boehringer Ingelheim Investigational Site
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Georgia
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Decatur, Georgia, Estados Unidos
- 1245.20.10080 Boehringer Ingelheim Investigational Site
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Indiana
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Avon, Indiana, Estados Unidos
- 1245.20.10128 Boehringer Ingelheim Investigational Site
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Fishers, Indiana, Estados Unidos
- 1245.20.10060 Boehringer Ingelheim Investigational Site
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Indianapolis, Indiana, Estados Unidos
- 1245.20.10065 Boehringer Ingelheim Investigational Site
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Kansas
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Arkansas City, Kansas, Estados Unidos
- 1245.20.10117 Boehringer Ingelheim Investigational Site
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Wichita, Kansas, Estados Unidos
- 1245.20.10039 Boehringer Ingelheim Investigational Site
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Kentucky
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Louisville, Kentucky, Estados Unidos
- 1245.20.10146 Boehringer Ingelheim Investigational Site
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Massachusetts
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Watertown, Massachusetts, Estados Unidos
- 1245.20.10144 Boehringer Ingelheim Investigational Site
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New Jersey
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Brick, New Jersey, Estados Unidos
- 1245.20.10115 Boehringer Ingelheim Investigational Site
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Ohio
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Carlisle, Ohio, Estados Unidos
- 1245.20.10129 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, Estados Unidos
- 1245.20.10045 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, Estados Unidos
- 1245.20.10119 Boehringer Ingelheim Investigational Site
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Gallipolis, Ohio, Estados Unidos
- 1245.20.10130 Boehringer Ingelheim Investigational Site
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Texas
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Houston, Texas, Estados Unidos
- 1245.20.10089 Boehringer Ingelheim Investigational Site
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Hurst, Texas, Estados Unidos
- 1245.20.10151 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, Estados Unidos
- 1245.20.10155 Boehringer Ingelheim Investigational Site
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Bangalore, India
- 1245.20.91005 Boehringer Ingelheim Investigational Site
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Bangalore, India
- 1245.20.91006 Boehringer Ingelheim Investigational Site
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Bangalore, India
- 1245.20.91008 Boehringer Ingelheim Investigational Site
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Belgaum, India
- 1245.20.91003 Boehringer Ingelheim Investigational Site
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Chennai, India
- 1245.20.91004 Boehringer Ingelheim Investigational Site
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Chennai, India
- 1245.20.91009 Boehringer Ingelheim Investigational Site
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Mumbai, India
- 1245.20.91002 Boehringer Ingelheim Investigational Site
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Mumbai, Maharastra, India
- 1245.20.91007 Boehringer Ingelheim Investigational Site
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Nagpur, India
- 1245.20.91010 Boehringer Ingelheim Investigational Site
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Tamil Nadu, India
- 1245.20.91001 Boehringer Ingelheim Investigational Site
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Co. Cork, Irlanda
- 1245.20.35302 Boehringer Ingelheim Investigational Site
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Co. Galway, Irlanda
- 1245.20.35305 Boehringer Ingelheim Investigational Site
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Co. Wexford, Irlanda
- 1245.20.35303 Boehringer Ingelheim Investigational Site
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Offaly, Irlanda
- 1245.20.35304 Boehringer Ingelheim Investigational Site
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Wexford, Irlanda
- 1245.20.35306 Boehringer Ingelheim Investigational Site
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Chiyoda-ku, Tokyo, Japón
- 1245.20.81007 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Japón
- 1245.20.81001 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Japón
- 1245.20.81002 Boehringer Ingelheim Investigational Site
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Ebetsu, Hokkaido, Japón
- 1245.20.81005 Boehringer Ingelheim Investigational Site
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Kamakura, Kanagawa, Japón
- 1245.20.81004 Boehringer Ingelheim Investigational Site
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Minato-ku, Tokyo, Japón
- 1245.20.81003 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japón
- 1245.20.81006 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japón
- 1245.20.81008 Boehringer Ingelheim Investigational Site
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Suita, Osaka, Japón
- 1245.20.81009 Boehringer Ingelheim Investigational Site
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Ube, Yamaguchi, Japón
- 1245.20.81010 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japón
- 1245.20.81012 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japón
- 1245.20.81013 Boehringer Ingelheim Investigational Site
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Beijing, Porcelana
- 1245.20.86007 Boehringer Ingelheim Investigational Site
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Beijing, Porcelana
- 1245.20.86008 Boehringer Ingelheim Investigational Site
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Guangzhou, Porcelana
- 1245.20.86001 Boehringer Ingelheim Investigational Site
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Guangzhou, Porcelana
- 1245.20.86002 Boehringer Ingelheim Investigational Site
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Guangzhou, Porcelana
- 1245.20.86003 Boehringer Ingelheim Investigational Site
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Guiyang, Porcelana
- 1245.20.86012 Boehringer Ingelheim Investigational Site
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Hangzhou, Porcelana
- 1245.20.86020 Boehringer Ingelheim Investigational Site
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Jinan, Porcelana
- 1245.20.86049 Boehringer Ingelheim Investigational Site
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Jingzhou, Porcelana
- 1245.20.86018 Boehringer Ingelheim Investigational Site
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Nanchang, Porcelana
- 1245.20.86019 Boehringer Ingelheim Investigational Site
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Nanjing, Porcelana
- 1245.20.86010 Boehringer Ingelheim Investigational Site
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Nanjing, Porcelana
- 1245.20.86043 Boehringer Ingelheim Investigational Site
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QingDao, Porcelana
- 1245.20.86016 Boehringer Ingelheim Investigational Site
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Shanghai, Porcelana
- 1245.20.86004 Boehringer Ingelheim Investigational Site
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Shanghai, Porcelana
- 1245.20.86005 Boehringer Ingelheim Investigational Site
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Shanghai, Porcelana
- 1245.20.86006 Boehringer Ingelheim Investigational Site
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Shenyang, Porcelana
- 1245.20.86057 Boehringer Ingelheim Investigational Site
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Shiyan, Porcelana
- 1245.20.86017 Boehringer Ingelheim Investigational Site
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Suzhou, Porcelana
- 1245.20.86013 Boehringer Ingelheim Investigational Site
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Taiyuan, Porcelana
- 1245.20.86015 Boehringer Ingelheim Investigational Site
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Wuhan, Porcelana
- 1245.20.86009 Boehringer Ingelheim Investigational Site
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Xi'An, Porcelana
- 1245.20.86011 Boehringer Ingelheim Investigational Site
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Xiamen, Porcelana
- 1245.20.86014 Boehringer Ingelheim Investigational Site
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Lugano, Suiza
- 1245.20.41004 Boehringer Ingelheim Investigational Site
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Rorschach, Suiza
- 1245.20.41003 Boehringer Ingelheim Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus prior to informed consent;
- Male and female patients on diet and exercise regimen who are drug-naïve;
- HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
- Age >= 20 (Japan); Age >= 18 (countries other than Japan);
- BMI <= 45 kg/m2 at Visit 1 (screening);
- Signed and dated written informed consent by date of Visit 1
Exclusion criteria:
- Uncontrolled hyperglycaemia;
- Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
- Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
- Impaired renal function (eGFR<50 ml/min);
- Bariatric surgery within the past two years or other GI surgeries;
- Medical history of cancer;
- Contraindications to sitagliptin;
- Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
- Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
- Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
- Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
- Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
- Alcohol or drug abuse;
- Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: BI 10773 low dose
Patients receive BI 10773 low dose tablets once daily
|
BI 10773 tableta de dosis baja una vez al día
placebo tablets once daily
placebo tablets once daily
|
Experimental: BI 10773 high dose
Patients receive BI 10773 high dose tablets once daily
|
placebo tablets once daily
placebo tablets once daily
BI 10773 high dose tablets once daily
|
Comparador de placebos: Placebo
Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
|
placebo tablets once daily
placebo tablets once daily
placebo tablets once daily
|
Comparador activo: Sitagliptin 100 mg
Patients receive Sitagliptin 100 mg tablets once daily
|
placebo tablets once daily
placebo tablets once daily
Sitagliptin tablets 100 mg once daily
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Experimental: BI 10773 high dose open label
Patients receive BI 10773 high dose tablets open label once daily
|
Patients receive BI 10773 high dose tablets open label once daily
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
Periodo de tiempo: Baseline and day 169
|
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. |
Baseline and day 169
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline to Week 24 in Body Weight
Periodo de tiempo: Baseline and day 169
|
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. |
Baseline and day 169
|
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
Periodo de tiempo: Baseline and week 24
|
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored. |
Baseline and week 24
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Confirmed Hypoglycaemic Adverse Events
Periodo de tiempo: From first drug intake until 7 days after last medication intake, up to 219 days
|
Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required. Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category. |
From first drug intake until 7 days after last medication intake, up to 219 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.
- Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Diabetes Mellitus, Tipo 2
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Inhibidores de la proteasa
- Incretinas
- Inhibidores del transportador de sodio-glucosa 2
- Inhibidores de la dipeptidil-peptidasa IV
- Empagliflozina
- Fosfato de sitagliptina
Otros números de identificación del estudio
- 1245.20
- 2009-016243-20 (Número EudraCT: EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre BI 10773
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Boehringer IngelheimEli Lilly and CompanyTerminadoDiabetes Mellitus, Tipo 2Estados Unidos, Argentina, Australia, Austria, Bélgica, Brasil, Canadá, Colombia, Croacia, República Checa, Dinamarca, Estonia, Francia, Georgia, Grecia, Hong Kong, Hungría, India, Indonesia, Israel, Italia, Japón, Corea, república de, M... y más
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Boehringer IngelheimEli Lilly and CompanyTerminadoDiabetes Mellitus, Tipo 2Estados Unidos, Dinamarca, Francia, Irlanda, Corea, república de, Portugal, Reino Unido
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Boehringer IngelheimEli Lilly and CompanyTerminadoDiabetes Mellitus, Tipo 2Estados Unidos, Canadá, Porcelana, Francia, Alemania, India, Corea, república de, México, Eslovaquia, Eslovenia, Taiwán, Pavo
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado