Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT01306214
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 566
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 10773 low dose Placebo BI 10773 low dose once daily BI 10773 low dose BI 10773 BI 10773 low dose once daily BI 10773 high dose Placebo BI 10733 high dose once daily BI 10773 high dose BI 10773 BI 10733 high dose once daily Placebo Placebo Placebo tablets matching BI 10773
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c After 18 Weeks of Treatment Baseline and 18 weeks The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Insulin Dose After 52 Weeks of Treatment Baseline and 52 weeks The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment
Change From Baseline in Body Weight After 52 Weeks of Treatment Baseline and 52 weeks The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment
Change From Baseline in HbA1c After 52 Weeks of Treatment Baseline and 52 weeks The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment
Trial Locations
- Locations (103)
1245.49.10019 Boehringer Ingelheim Investigational Site
🇺🇸Westlake Village, California, United States
1245.49.10007 Boehringer Ingelheim Investigational Site
🇺🇸Fargo, North Dakota, United States
1245.49.10015 Boehringer Ingelheim Investigational Site
🇺🇸Evansville, Indiana, United States
1245.49.10033 Boehringer Ingelheim Investigational Site
🇺🇸Bountiful, Utah, United States
1245.49.32010 Boehringer Ingelheim Investigational Site
🇧🇪Bonheiden, Belgium
1245.49.34016 Boehringer Ingelheim Investigational Site
🇪🇸Santiago de Compostela (La Coruña), Spain
1245.49.49002 Boehringer Ingelheim Investigational Site
🇩🇪Neuwied, Germany
1245.49.49005 Boehringer Ingelheim Investigational Site
🇩🇪Saarbrücken, Germany
1245.49.75016 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1245.49.75014 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1245.49.34044 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1245.49.42010 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1245.49.10011 Boehringer Ingelheim Investigational Site
🇺🇸Chandler, Arizona, United States
1245.49.10002 Boehringer Ingelheim Investigational Site
🇺🇸Corona, California, United States
1245.49.10013 Boehringer Ingelheim Investigational Site
🇺🇸El Cajon, California, United States
1245.49.10030 Boehringer Ingelheim Investigational Site
🇺🇸Lomita, California, United States
1245.49.10025 Boehringer Ingelheim Investigational Site
🇺🇸Greer, South Carolina, United States
1245.49.10022 Boehringer Ingelheim Investigational Site
🇺🇸Memphis, Tennessee, United States
1245.49.10020 Boehringer Ingelheim Investigational Site
🇺🇸Renton, Washington, United States
1245.49.10026 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
1245.49.32002 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1245.49.59004 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1245.49.59003 Boehringer Ingelheim Investigational Site
🇧🇬Pleven, Bulgaria
1245.49.57003 Boehringer Ingelheim Investigational Site
🇨🇴Barranquilla, Colombia
1245.49.59001 Boehringer Ingelheim Investigational Site
🇧🇬Stara Zagora, Bulgaria
1245.49.57004 Boehringer Ingelheim Investigational Site
🇨🇴Bogotá, Colombia
1245.49.57005 Boehringer Ingelheim Investigational Site
🇨🇴Bogota, Colombia
1245.49.42013 Boehringer Ingelheim Investigational Site
🇨🇿Breclav, Czech Republic
1245.49.42003 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1245.49.42011 Boehringer Ingelheim Investigational Site
🇨🇿Chrudim, Czech Republic
1245.49.33011 Boehringer Ingelheim Investigational Site
🇫🇷Le Creusot, France
1245.49.33001 Boehringer Ingelheim Investigational Site
🇫🇷Grenoble Cedex, France
1245.49.33010 Boehringer Ingelheim Investigational Site
🇫🇷Narbonne Cedex, France
1245.49.33003 Boehringer Ingelheim Investigational Site
🇫🇷Nantes cedex 1, France
1245.49.33012 Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1245.49.33007 Boehringer Ingelheim Investigational Site
🇫🇷Point-à -Pitre Cedex, France
1245.49.33004 Boehringer Ingelheim Investigational Site
🇫🇷Pierre Benite, France
1245.49.33008 Boehringer Ingelheim Investigational Site
🇫🇷Saint Priest en Jarez, France
1245.49.49104 Boehringer Ingelheim Investigational Site
🇩🇪Bosenheim, Germany
1245.49.49013 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
1245.49.33009 Boehringer Ingelheim Investigational Site
🇫🇷Vénissieux Cedex, France
1245.49.49101 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1245.49.49102 Boehringer Ingelheim Investigational Site
🇩🇪Wangen, Germany
1245.49.50201 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala, Guatemala
1245.49.50202 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala, Guatemala
1245.49.50204 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala, Guatemala
1245.49.50205 Boehringer Ingelheim Investigational Site
🇬🇹Quetzaltenango, Guatemala
1245.49.52003 Boehringer Ingelheim Investigational Site
🇲🇽Durango, Mexico
1245.49.52012 Boehringer Ingelheim Investigational Site
🇲🇽Cuautla, Mexico
1245.49.52004 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1245.49.52005 Boehringer Ingelheim Investigational Site
🇲🇽Durango, Mexico
1245.49.52006 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1245.49.52002 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
1245.49.52009 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
1245.49.51006 Boehringer Ingelheim Investigational Site
🇵🇪Arequipa, Peru
1245.49.51002 Boehringer Ingelheim Investigational Site
🇵🇪Arequipa, Peru
1245.49.52001 Boehringer Ingelheim Investigational Site
🇲🇽México, D.F., Mexico
1245.49.51010 Boehringer Ingelheim Investigational Site
🇵🇪Jesus Maria, Peru
1245.49.70008 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.49.70006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1245.49.70009 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.49.51009 Boehringer Ingelheim Investigational Site
🇵🇪Lima, Peru
1245.49.51008 Boehringer Ingelheim Investigational Site
🇵🇪Lima, Peru
1245.49.34039 Boehringer Ingelheim Investigational Site
🇪🇸Avila, Spain
1245.49.34038 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1245.49.34047 Boehringer Ingelheim Investigational Site
🇪🇸Palma de Mallorca, Spain
1245.49.34043 Boehringer Ingelheim Investigational Site
🇪🇸MBoadilla del Monte (Madrid), Spain
1245.49.34045 Boehringer Ingelheim Investigational Site
🇪🇸pozuelo de Alarcon, Spain
1245.49.75007 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1245.49.34041 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1245.49.10014 Boehringer Ingelheim Investigational Site
🇺🇸Spring Valley, California, United States
1245.49.32013 Boehringer Ingelheim Investigational Site
🇧🇪La Louvière, Belgium
1245.49.32012 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1245.49.57006 Boehringer Ingelheim Investigational Site
🇨🇴Bogota, Colombia
1245.49.52011 Boehringer Ingelheim Investigational Site
🇲🇽Aguascalientes, Mexico
1245.49.52008 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1245.49.57002 Boehringer Ingelheim Investigational Site
🇨🇴MedellÃn, Colombia
1245.49.42009 Boehringer Ingelheim Investigational Site
🇨🇿Hodonin, Czech Republic
1245.49.72002 Boehringer Ingelheim Investigational Site
🇫🇮Oulu, Finland
1245.49.50203 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala, Guatemala
1245.49.75015 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1245.49.32007 Boehringer Ingelheim Investigational Site
🇧🇪Huy, Belgium
1245.49.42012 Boehringer Ingelheim Investigational Site
🇨🇿Svitavy56802, Czech Republic
1245.49.10004 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
1245.49.72003 Boehringer Ingelheim Investigational Site
🇫🇮Turku, Finland
1245.49.52010 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
1245.49.32014 Boehringer Ingelheim Investigational Site
🇧🇪Jette, Belgium
1245.49.72001 Boehringer Ingelheim Investigational Site
🇫🇮Kuopio, Finland
1245.49.51001 Boehringer Ingelheim Investigational Site
🇵🇪Lima, Peru
1245.49.70010 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1245.49.75013 Boehringer Ingelheim Investigational Site
🇺🇦Kyiv, Ukraine
1245.49.10021 Boehringer Ingelheim Investigational Site
🇺🇸Blue Ridge, Georgia, United States
1245.49.10009 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1245.49.10003 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1245.49.10001 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1245.49.10031 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1245.49.10006 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Ohio, United States
1245.49.10005 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1245.49.10016 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1245.49.10024 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
1245.49.10018 Boehringer Ingelheim Investigational Site
🇺🇸Hialeah, Florida, United States
1245.49.10023 Boehringer Ingelheim Investigational Site
🇺🇸Greenville, North Carolina, United States
1245.49.10032 Boehringer Ingelheim Investigational Site
🇺🇸Salt Lake City, Utah, United States