- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Bruxelles, Belgio
- 1245.20.32008 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgio
- 1245.20.32011 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgio
- 1245.20.32023 Boehringer Ingelheim Investigational Site
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De Pinte, Belgio
- 1245.20.32003 Boehringer Ingelheim Investigational Site
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Deurne, Belgio
- 1245.20.32015 Boehringer Ingelheim Investigational Site
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Deurne, Belgio
- 1245.20.32016 Boehringer Ingelheim Investigational Site
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Gozée, Belgio
- 1245.20.32025 Boehringer Ingelheim Investigational Site
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Landen, Belgio
- 1245.20.32022 Boehringer Ingelheim Investigational Site
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Leopoldsburg, Belgio
- 1245.20.32019 Boehringer Ingelheim Investigational Site
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Linkebeek, Belgio
- 1245.20.32024 Boehringer Ingelheim Investigational Site
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Mouscron, Belgio
- 1245.20.32021 Boehringer Ingelheim Investigational Site
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Retie, Belgio
- 1245.20.32027 Boehringer Ingelheim Investigational Site
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Sint-Gillis-Waas, Belgio
- 1245.20.32020 Boehringer Ingelheim Investigational Site
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Tielt, Belgio
- 1245.20.32018 Boehringer Ingelheim Investigational Site
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Tremelo, Belgio
- 1245.20.32026 Boehringer Ingelheim Investigational Site
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British Columbia
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Chilliwack, British Columbia, Canada
- 1245.20.20011 Boehringer Ingelheim Investigational Site
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Victoria, British Columbia, Canada
- 1245.20.20018 Boehringer Ingelheim Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada
- 1245.20.20015 Boehringer Ingelheim Investigational Site
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New Brunswick
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Moncton, New Brunswick, Canada
- 1245.20.20012 Boehringer Ingelheim Investigational Site
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Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada
- 1245.20.20016 Boehringer Ingelheim Investigational Site
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St. John's, Newfoundland and Labrador, Canada
- 1245.20.20008 Boehringer Ingelheim Investigational Site
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Ontario
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Barrie, Ontario, Canada
- 1245.20.20001 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
- 1245.20.20019 Boehringer Ingelheim Investigational Site
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London, Ontario, Canada
- 1245.20.20010 Boehringer Ingelheim Investigational Site
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London, Ontario, Canada
- 1245.20.20017 Boehringer Ingelheim Investigational Site
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Markham, Ontario, Canada
- 1245.20.20003 Boehringer Ingelheim Investigational Site
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Newmarket, Ontario, Canada
- 1245.20.20009 Boehringer Ingelheim Investigational Site
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Ottawa, Ontario, Canada
- 1245.20.20013 Boehringer Ingelheim Investigational Site
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Strathroy, Ontario, Canada
- 1245.20.20005 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
- 1245.20.20002 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
- 1245.20.20006 Boehringer Ingelheim Investigational Site
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
- 1245.20.20014 Boehringer Ingelheim Investigational Site
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Montague, Prince Edward Island, Canada
- 1245.20.20007 Boehringer Ingelheim Investigational Site
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Quebec
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Trois Rivieres, Quebec, Canada
- 1245.20.20021 Boehringer Ingelheim Investigational Site
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Beijing, Cina
- 1245.20.86007 Boehringer Ingelheim Investigational Site
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Beijing, Cina
- 1245.20.86008 Boehringer Ingelheim Investigational Site
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Guangzhou, Cina
- 1245.20.86001 Boehringer Ingelheim Investigational Site
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Guangzhou, Cina
- 1245.20.86002 Boehringer Ingelheim Investigational Site
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Guangzhou, Cina
- 1245.20.86003 Boehringer Ingelheim Investigational Site
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Guiyang, Cina
- 1245.20.86012 Boehringer Ingelheim Investigational Site
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Hangzhou, Cina
- 1245.20.86020 Boehringer Ingelheim Investigational Site
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Jinan, Cina
- 1245.20.86049 Boehringer Ingelheim Investigational Site
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Jingzhou, Cina
- 1245.20.86018 Boehringer Ingelheim Investigational Site
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Nanchang, Cina
- 1245.20.86019 Boehringer Ingelheim Investigational Site
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Nanjing, Cina
- 1245.20.86010 Boehringer Ingelheim Investigational Site
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Nanjing, Cina
- 1245.20.86043 Boehringer Ingelheim Investigational Site
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QingDao, Cina
- 1245.20.86016 Boehringer Ingelheim Investigational Site
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Shanghai, Cina
- 1245.20.86004 Boehringer Ingelheim Investigational Site
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Shanghai, Cina
- 1245.20.86005 Boehringer Ingelheim Investigational Site
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Shanghai, Cina
- 1245.20.86006 Boehringer Ingelheim Investigational Site
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Shenyang, Cina
- 1245.20.86057 Boehringer Ingelheim Investigational Site
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Shiyan, Cina
- 1245.20.86017 Boehringer Ingelheim Investigational Site
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Suzhou, Cina
- 1245.20.86013 Boehringer Ingelheim Investigational Site
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Taiyuan, Cina
- 1245.20.86015 Boehringer Ingelheim Investigational Site
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Wuhan, Cina
- 1245.20.86009 Boehringer Ingelheim Investigational Site
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Xi'An, Cina
- 1245.20.86011 Boehringer Ingelheim Investigational Site
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Xiamen, Cina
- 1245.20.86014 Boehringer Ingelheim Investigational Site
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Dresden, Germania
- 1245.20.49013 Boehringer Ingelheim Investigational Site
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Düsseldorf, Germania
- 1245.20.49016 Boehringer Ingelheim Investigational Site
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Frankfurt, Germania
- 1245.20.49015 Boehringer Ingelheim Investigational Site
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Haag, Germania
- 1245.20.49019 Boehringer Ingelheim Investigational Site
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Hohenmölsen, Germania
- 1245.20.49020 Boehringer Ingelheim Investigational Site
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Köthen, Germania
- 1245.20.49014 Boehringer Ingelheim Investigational Site
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Neuwied, Germania
- 1245.20.49002 Boehringer Ingelheim Investigational Site
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Nürnberg, Germania
- 1245.20.49008 Boehringer Ingelheim Investigational Site
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Schauenburg, Germania
- 1245.20.49022 Boehringer Ingelheim Investigational Site
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St. Ingbert/Oberwürzbach, Germania
- 1245.20.49017 Boehringer Ingelheim Investigational Site
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Unterschneidheim, Germania
- 1245.20.49003 Boehringer Ingelheim Investigational Site
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Chiyoda-ku, Tokyo, Giappone
- 1245.20.81007 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Giappone
- 1245.20.81001 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Giappone
- 1245.20.81002 Boehringer Ingelheim Investigational Site
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Ebetsu, Hokkaido, Giappone
- 1245.20.81005 Boehringer Ingelheim Investigational Site
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Kamakura, Kanagawa, Giappone
- 1245.20.81004 Boehringer Ingelheim Investigational Site
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Minato-ku, Tokyo, Giappone
- 1245.20.81003 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Giappone
- 1245.20.81006 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Giappone
- 1245.20.81008 Boehringer Ingelheim Investigational Site
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Suita, Osaka, Giappone
- 1245.20.81009 Boehringer Ingelheim Investigational Site
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Ube, Yamaguchi, Giappone
- 1245.20.81010 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Giappone
- 1245.20.81012 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Giappone
- 1245.20.81013 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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Arizona
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Mesa, Arizona, Stati Uniti
- 1245.20.10124 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, Stati Uniti
- 1245.20.10108 Boehringer Ingelheim Investigational Site
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Arkansas
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Hot Springs, Arkansas, Stati Uniti
- 1245.20.10150 Boehringer Ingelheim Investigational Site
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California
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Chino, California, Stati Uniti
- 1245.20.10154 Boehringer Ingelheim Investigational Site
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Santa Ana, California, Stati Uniti
- 1245.20.10009 Boehringer Ingelheim Investigational Site
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West Hills, California, Stati Uniti
- 1245.20.10131 Boehringer Ingelheim Investigational Site
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Colorado
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Northglenn, Colorado, Stati Uniti
- 1245.20.10038 Boehringer Ingelheim Investigational Site
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Florida
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Clearwater, Florida, Stati Uniti
- 1245.20.10137 Boehringer Ingelheim Investigational Site
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Miami, Florida, Stati Uniti
- 1245.20.10006 Boehringer Ingelheim Investigational Site
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Plantation, Florida, Stati Uniti
- 1245.20.10085 Boehringer Ingelheim Investigational Site
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Tampa, Florida, Stati Uniti
- 1245.20.10078 Boehringer Ingelheim Investigational Site
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Georgia
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Decatur, Georgia, Stati Uniti
- 1245.20.10080 Boehringer Ingelheim Investigational Site
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Indiana
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Avon, Indiana, Stati Uniti
- 1245.20.10128 Boehringer Ingelheim Investigational Site
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Fishers, Indiana, Stati Uniti
- 1245.20.10060 Boehringer Ingelheim Investigational Site
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Indianapolis, Indiana, Stati Uniti
- 1245.20.10065 Boehringer Ingelheim Investigational Site
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Kansas
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Arkansas City, Kansas, Stati Uniti
- 1245.20.10117 Boehringer Ingelheim Investigational Site
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Wichita, Kansas, Stati Uniti
- 1245.20.10039 Boehringer Ingelheim Investigational Site
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Kentucky
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Louisville, Kentucky, Stati Uniti
- 1245.20.10146 Boehringer Ingelheim Investigational Site
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Massachusetts
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Watertown, Massachusetts, Stati Uniti
- 1245.20.10144 Boehringer Ingelheim Investigational Site
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New Jersey
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Brick, New Jersey, Stati Uniti
- 1245.20.10115 Boehringer Ingelheim Investigational Site
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Ohio
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Carlisle, Ohio, Stati Uniti
- 1245.20.10129 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, Stati Uniti
- 1245.20.10045 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, Stati Uniti
- 1245.20.10119 Boehringer Ingelheim Investigational Site
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Gallipolis, Ohio, Stati Uniti
- 1245.20.10130 Boehringer Ingelheim Investigational Site
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Texas
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Houston, Texas, Stati Uniti
- 1245.20.10089 Boehringer Ingelheim Investigational Site
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Hurst, Texas, Stati Uniti
- 1245.20.10151 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, Stati Uniti
- 1245.20.10155 Boehringer Ingelheim Investigational Site
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Lugano, Svizzera
- 1245.20.41004 Boehringer Ingelheim Investigational Site
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Rorschach, Svizzera
- 1245.20.41003 Boehringer Ingelheim Investigational Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: BI 10773 low dose
Patients receive BI 10773 low dose tablets once daily
|
BI 10773 compresse a basso dosaggio una volta al giorno
placebo tablets once daily
placebo tablets once daily
|
Sperimentale: BI 10773 high dose
Patients receive BI 10773 high dose tablets once daily
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placebo tablets once daily
placebo tablets once daily
BI 10773 high dose tablets once daily
|
Comparatore placebo: 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
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Comparatore attivo: Sitagliptin 100 mg
Patients receive Sitagliptin 100 mg tablets once daily
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placebo tablets once daily
placebo tablets once daily
Sitagliptin tablets 100 mg once daily
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Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline to Week 24 in Body Weight
Lasso di tempo: 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)
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Confirmed Hypoglycaemic Adverse Events
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema endocrino
- Diabete mellito
- Diabete mellito, tipo 2
- Agenti ipoglicemizzanti
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Inibitori della proteasi
- Incretine
- Inibitori del trasportatore sodio-glucosio 2
- Inibitori della dipeptidil-peptidasi IV
- Empagliflozin
- Sitagliptin fosfato
Altri numeri di identificazione dello studio
- 1245.20
- 2009-016243-20 (Numero EudraCT: EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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