Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: BI 10773Drug: Placebo identical to BI 10773 high doseDrug: Placebo identical to BI 10773 low dose
- Registration Number
- NCT01159600
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1504
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo identical to BI 10773 high dose Placebo matching BI 10773 BI 10773 open-label BI 10773 BI 10773 once daily high dose open label BI 10773 Arm 2 BI 10773 BI 10773 once daily high dose BI 10773 Arm 2 Placebo identical to BI 10773 low dose BI 10773 once daily high dose Placebo Placebo identical to BI 10773 low dose Placebo matching BI 10773 BI 10773 Arm 1 Placebo identical to BI 10773 high dose BI 10773 once daily low dose BI 10773 Arm 1 BI 10773 BI 10773 once daily low dose
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline Baseline and 24 weeks Change from baseline in HbA1c after 24 weeks.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
- Secondary Outcome Measures
Name Time Method Body Weight Change From Baseline Baseline and 24 weeks Body weight change from baseline after 24 weeks.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.Mean Daily Plasma Glucose (MDG) Change From Baseline Baseline and 24 weeks Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Trial Locations
- Locations (148)
1245.23.20033 Boehringer Ingelheim Investigational Site
🇨🇦Victoria, British Columbia, Canada
1245.23.10001 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1245.23.10127 Boehringer Ingelheim Investigational Site
🇺🇸Waterbury, Connecticut, United States
1245.23.20039 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1245.23.20038 Boehringer Ingelheim Investigational Site
🇨🇦Ville Saint-Laurent, Quebec, Canada
1245.23.33003 Boehringer Ingelheim Investigational Site
🇫🇷La Rochelle Cedex 1, France
1245.23.91104 Boehringer Ingelheim Investigational Site
🇮🇳Indore, India
1245.23.91103 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
1245.23.82012 Boehringer Ingelheim Investigational Site
🇰🇷Anyang, Korea, Republic of
1245.23.82002 Boehringer Ingelheim Investigational Site
🇰🇷Suwon, Korea, Republic of
1245.23.82003 Boehringer Ingelheim Investigational Site
🇰🇷Wonju, Korea, Republic of
1245.23.52003 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1245.23.52004 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1245.23.82007 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1245.23.82010 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1245.23.74005 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1245.23.74002 Boehringer Ingelheim Investigational Site
🇸🇰Lucenec, Slovakia
1245.23.88014 Boehringer Ingelheim Investigational Site
🇨🇳Tainan, Taiwan
1245.23.90003 Boehringer Ingelheim Investigational Site
🇹🇷Erzurum, Turkey
1245.23.90007 Boehringer Ingelheim Investigational Site
🇹🇷Istanbul, Turkey
1245.23.86034 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1245.23.86036 Boehringer Ingelheim Investigational Site
🇨🇳Tianjin, China
1245.23.10109 Boehringer Ingelheim Investigational Site
🇺🇸Huntington Park, California, United States
1245.23.10074 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1245.23.10159 Boehringer Ingelheim Investigational Site
🇺🇸Des Moines, Iowa, United States
1245.23.10034 Boehringer Ingelheim Investigational Site
🇺🇸Rochester, New York, United States
1245.23.10123 Boehringer Ingelheim Investigational Site
🇺🇸Smithtown, New York, United States
1245.23.10157 Boehringer Ingelheim Investigational Site
🇺🇸Newton, Kansas, United States
1245.23.10117 Boehringer Ingelheim Investigational Site
🇺🇸Arkansas City, Kansas, United States
1245.23.10145 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1245.23.10031 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
1245.23.10106 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1245.23.10046 Boehringer Ingelheim Investigational Site
🇺🇸Tempe, Arizona, United States
1245.23.10095 Boehringer Ingelheim Investigational Site
🇺🇸Huntington Park, California, United States
1245.23.10133 Boehringer Ingelheim Investigational Site
🇺🇸Jupiter, Florida, United States
1245.23.10149 Boehringer Ingelheim Investigational Site
🇺🇸Rancho Cucamonga, California, United States
1245.23.10042 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
1245.23.10080 Boehringer Ingelheim Investigational Site
🇺🇸Decatur, Georgia, United States
1245.23.10148 Boehringer Ingelheim Investigational Site
🇺🇸Lexington, Kentucky, United States
1245.23.10120 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Ohio, United States
1245.23.10015 Boehringer Ingelheim Investigational Site
🇺🇸Simpsonville, South Carolina, United States
1245.23.10158 Boehringer Ingelheim Investigational Site
🇺🇸Mount Pleasant, South Carolina, United States
1245.23.10156 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1245.23.10143 Boehringer Ingelheim Investigational Site
🇺🇸Killeen, Texas, United States
1245.23.10153 Boehringer Ingelheim Investigational Site
🇺🇸Hurst, Texas, United States
1245.23.20023 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1245.23.20024 Boehringer Ingelheim Investigational Site
🇨🇦Paradise, Newfoundland and Labrador, Canada
1245.23.20032 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1245.23.20028 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1245.23.20026 Boehringer Ingelheim Investigational Site
🇨🇦Halifax, Nova Scotia, Canada
1245.23.20022 Boehringer Ingelheim Investigational Site
🇨🇦Brampton, Ontario, Canada
1245.23.20001 Boehringer Ingelheim Investigational Site
🇨🇦Barrie, Ontario, Canada
1245.23.20031 Boehringer Ingelheim Investigational Site
🇨🇦St. John's, Newfoundland and Labrador, Canada
1245.23.20035 Boehringer Ingelheim Investigational Site
🇨🇦Corunna, Ontario, Canada
1245.23.20030 Boehringer Ingelheim Investigational Site
🇨🇦Etobicoke, Ontario, Canada
1245.23.20037 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1245.23.20029 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1245.23.20003 Boehringer Ingelheim Investigational Site
🇨🇦Markham, Ontario, Canada
1245.23.20040 Boehringer Ingelheim Investigational Site
🇨🇦Oakville, Ontario, Canada
1245.23.20034 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1245.23.20025 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1245.23.20027 Boehringer Ingelheim Investigational Site
🇨🇦Laval, Quebec, Canada
1245.23.20036 Boehringer Ingelheim Investigational Site
🇨🇦Sherbrooke, Quebec, Canada
1245.23.86031 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1245.23.86032 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1245.23.86033 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1245.23.86058 Boehringer Ingelheim Investigational Site
🇨🇳Chongqing, China
1245.23.86048 Boehringer Ingelheim Investigational Site
🇨🇳Chengdu, China
1245.23.86035 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1245.23.86037 Boehringer Ingelheim Investigational Site
🇨🇳Haerbin, China
1245.23.86002 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
1245.23.86052 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
1245.23.86038 Boehringer Ingelheim Investigational Site
🇨🇳Dalian, China
1245.23.86049 Boehringer Ingelheim Investigational Site
🇨🇳Jinan, China
1245.23.86053 Boehringer Ingelheim Investigational Site
🇨🇳Jinan, China
1245.23.86055 Boehringer Ingelheim Investigational Site
🇨🇳Nan Ning, China
1245.23.86056 Boehringer Ingelheim Investigational Site
🇨🇳Nan Ning, China
1245.23.86040 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1245.23.86039 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1245.23.86054 Boehringer Ingelheim Investigational Site
🇨🇳Shantou, China
1245.23.86057 Boehringer Ingelheim Investigational Site
🇨🇳Shenyang, China
1245.23.86045 Boehringer Ingelheim Investigational Site
🇨🇳Shijiazhuang, China
1245.23.86041 Boehringer Ingelheim Investigational Site
🇨🇳Xi'An, China
1245.23.86013 Boehringer Ingelheim Investigational Site
🇨🇳Suzhou, China
1245.23.86051 Boehringer Ingelheim Investigational Site
🇨🇳Zhenjiang, China
1245.23.33008 Boehringer Ingelheim Investigational Site
🇫🇷Bersée, France
1245.23.33001 Boehringer Ingelheim Investigational Site
🇫🇷Corbeil Essonnes, France
1245.23.33015 Boehringer Ingelheim Investigational Site
🇫🇷Arras, France
1245.23.33002 Boehringer Ingelheim Investigational Site
🇫🇷Bondy Cedex, France
1245.23.33020 Boehringer Ingelheim Investigational Site
🇫🇷Bischheim, France
1245.23.33016 Boehringer Ingelheim Investigational Site
🇫🇷Bruay La Buissiere, France
1245.23.33010 Boehringer Ingelheim Investigational Site
🇫🇷Croix, France
1245.23.33009 Boehringer Ingelheim Investigational Site
🇫🇷Hautmont, France
1245.23.33014 Boehringer Ingelheim Investigational Site
🇫🇷Mundolsheim, France
1245.23.33045 Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1245.23.33004 Boehringer Ingelheim Investigational Site
🇫🇷Narbonne Cedex, France
1245.23.33012 Boehringer Ingelheim Investigational Site
🇫🇷Schiltigheim, France
1245.23.33019 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1245.23.49001 Boehringer Ingelheim Investigational Site
🇩🇪Dormagen, Germany
1245.23.33013 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1245.23.33018 Boehringer Ingelheim Investigational Site
🇫🇷Wattrelos, France
1245.23.33007 Boehringer Ingelheim Investigational Site
🇫🇷Vieux Condé, France
1245.23.49007 Boehringer Ingelheim Investigational Site
🇩🇪Künzing, Germany
1245.23.49009 Boehringer Ingelheim Investigational Site
🇩🇪Flörsheim, Germany
1245.23.49004 Boehringer Ingelheim Investigational Site
🇩🇪Hatten, Germany
1245.23.49002 Boehringer Ingelheim Investigational Site
🇩🇪Neuwied, Germany
1245.23.49008 Boehringer Ingelheim Investigational Site
🇩🇪Nürnberg, Germany
1245.23.49011 Boehringer Ingelheim Investigational Site
🇩🇪Rehlingen-Siersburg, Germany
1245.23.49005 Boehringer Ingelheim Investigational Site
🇩🇪Saarbrücken, Germany
1245.23.49010 Boehringer Ingelheim Investigational Site
🇩🇪Rednitzhembach, Germany
1245.23.49006 Boehringer Ingelheim Investigational Site
🇩🇪Rehburg-Loccum, Germany
1245.23.49003 Boehringer Ingelheim Investigational Site
🇩🇪Unterschneidheim, Germany
1245.23.91101 Boehringer Ingelheim Investigational Site
🇮🇳Coimbatore, India
1245.23.91102 Boehringer Ingelheim Investigational Site
🇮🇳Nagpur, India
1245.23.91105 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1245.23.82004 Boehringer Ingelheim Investigational Site
🇰🇷Busan, Korea, Republic of
1245.23.82011 Boehringer Ingelheim Investigational Site
🇰🇷Goyang, Korea, Republic of
1245.23.82001 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, Korea, Republic of
1245.23.82009 Boehringer Ingelheim Investigational Site
🇰🇷Ilsan, Korea, Republic of
1245.23.82006 Boehringer Ingelheim Investigational Site
🇰🇷Jeonju, Korea, Republic of
1245.23.82005 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1245.23.82008 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1245.23.52001 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
1245.23.52002 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
1245.23.74001 Boehringer Ingelheim Investigational Site
🇸🇰Povazska Bystrica, Slovakia
1245.23.74006 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
1245.23.74014 Boehringer Ingelheim Investigational Site
🇸🇰Nove Zamky, Slovakia
1245.23.74004 Boehringer Ingelheim Investigational Site
🇸🇰Presov, Slovakia
1245.23.38002 Boehringer Ingelheim Investigational Site
🇸🇮Koper, Slovenia
1245.23.88010 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1245.23.74003 Boehringer Ingelheim Investigational Site
🇸🇰Trebisov, Slovakia
1245.23.38003 Boehringer Ingelheim Investigational Site
🇸🇮Celje, Slovenia
1245.23.88011 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1245.23.38001 Boehringer Ingelheim Investigational Site
🇸🇮Maribor, Slovenia
1245.23.88009 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
1245.23.88012 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1245.23.88013 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1245.23.88006 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1245.23.88008 Boehringer Ingelheim Investigational Site
🇨🇳Taoyuan County, Taiwan
1245.23.88007 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1245.23.88021 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1245.23.90002 Boehringer Ingelheim Investigational Site
🇹🇷Istanbul, Turkey
1245.23.90001 Boehringer Ingelheim Investigational Site
🇹🇷Gaziantep, Turkey
1245.23.90006 Boehringer Ingelheim Investigational Site
🇹🇷Istanbul, Turkey
1245.23.90004 Boehringer Ingelheim Investigational Site
🇹🇷Izmir, Turkey
1245.23.82014 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1245.23.86043 Boehringer Ingelheim Investigational Site
🇨🇳Nanjing, China
1245.23.86042 Boehringer Ingelheim Investigational Site
🇨🇳Nanjing, China