Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
- Registration Number
- NCT01210001
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 499
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 10773 low dose BI 10773 BI 10773 tablets once daily BI 10773 low dose Placebo BI 10773 tablets once daily BI 10773 high dose Placebo BI 10773 tablets once daily BI 10773 high dose BI 10773 BI 10773 tablets once daily Placebo Placebo Placebo tablets matching BI 10773
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline for Pio and Met Background Medication Patients Baseline and 24 weeks Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.
Note that adjusted means are provided.HbA1c Change From Baseline Baseline and 24 weeks Change From Baseline in HbA1c after 24 weeks.
Note that adjusted means are provided.
- Secondary Outcome Measures
Name Time Method Fasting Plasma Glucose (FPG) Change From Baseline Baseline and 24 weeks Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.
Note that adjusted means are provided.Body Weight Change From Baseline Baseline and 24 weeks Change from baseline in body weight after 24 weeks.
Note that adjusted means are provided.
Trial Locations
- Locations (68)
1245.19.10070 Boehringer Ingelheim Investigational Site
🇺🇸Irvine, California, United States
1245.19.10161 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
1245.19.75006 Boehringer Ingelheim Investigational Site
🇺🇦Lviv, Ukraine
1245.19.10056 Boehringer Ingelheim Investigational Site
🇺🇸Muscle Shoals, Alabama, United States
1245.19.10162 Boehringer Ingelheim Investigational Site
🇺🇸Glendale, Arizona, United States
1245.19.10047 Boehringer Ingelheim Investigational Site
🇺🇸La Mesa, California, United States
1245.19.10149 Boehringer Ingelheim Investigational Site
🇺🇸Rancho Cucamonga, California, United States
1245.19.10131 Boehringer Ingelheim Investigational Site
🇺🇸West Hills, California, United States
1245.19.10163 Boehringer Ingelheim Investigational Site
🇺🇸Riverside, California, United States
1245.19.10133 Boehringer Ingelheim Investigational Site
🇺🇸Jupiter, Florida, United States
1245.19.10077 Boehringer Ingelheim Investigational Site
🇺🇸Perry, Georgia, United States
1245.19.10141 Boehringer Ingelheim Investigational Site
🇺🇸Milford, Connecticut, United States
1245.19.10085 Boehringer Ingelheim Investigational Site
🇺🇸Plantation, Florida, United States
1245.19.10014 Boehringer Ingelheim Investigational Site
🇺🇸Dubuque, Iowa, United States
1245.19.10160 Boehringer Ingelheim Investigational Site
🇺🇸Essex, Maryland, United States
1245.19.10003 Boehringer Ingelheim Investigational Site
🇺🇸Dearborn, Michigan, United States
1245.19.10059 Boehringer Ingelheim Investigational Site
🇺🇸New Hyde Park, New York, United States
1245.19.10123 Boehringer Ingelheim Investigational Site
🇺🇸Smithtown, New York, United States
1245.19.10071 Boehringer Ingelheim Investigational Site
🇺🇸Asheboro, North Carolina, United States
1245.19.10008 Boehringer Ingelheim Investigational Site
🇺🇸Marion, Ohio, United States
1245.19.10112 Boehringer Ingelheim Investigational Site
🇺🇸Memphis, Tennessee, United States
1245.19.10086 Boehringer Ingelheim Investigational Site
🇺🇸Salisbury, North Carolina, United States
1245.19.10002 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
1245.19.20012 G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
1245.19.20057 Boehringer Ingelheim Investigational Site
🇨🇦Brampton, Ontario, Canada
1245.19.20031 Boehringer Ingelheim Investigational Site
🇨🇦St. John's, Newfoundland and Labrador, Canada
1245.19.20009 Boehringer Ingelheim Investigational Site
🇨🇦Newmarket, Ontario, Canada
1245.19.20060 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1245.19.20034 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1245.19.20041 Boehringer Ingelheim Investigational Site
🇨🇦Saskatoon, Saskatchewan, Canada
1245.19.20058 Boehringer Ingelheim Investigational Site
🇨🇦St-Romuald, Quebec, Canada
1245.19.91005 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1245.19.91006 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1245.19.30001 Boehringer Ingelheim Investigational Site
🇬🇷Nikaia, Greece
1245.19.30002 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1245.19.30004 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1245.19.91004 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1245.19.91008 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1245.19.91003 Boehringer Ingelheim Investigational Site
🇮🇳Belgaum, India
1245.19.91009 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1245.19.91001 Boehringer Ingelheim Investigational Site
🇮🇳Coimbatore, India
1245.19.91015 Boehringer Ingelheim Investigational Site
🇮🇳Gulbarga, India
1245.19.91011 Boehringer Ingelheim Investigational Site
🇮🇳Kartanaka, India
1245.19.91007 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, Maharastra, India
1245.19.91002 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1245.19.91017 Boehringer Ingelheim Investigational Site
🇮🇳Mysore, India
1245.19.91010 Boehringer Ingelheim Investigational Site
🇮🇳Nagpur, India
1245.19.91012 Boehringer Ingelheim Investigational Site
🇮🇳New Delhi, India
1245.19.91013 Boehringer Ingelheim Investigational Site
🇮🇳Patna, India
1245.19.91014 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1245.19.91016 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1245.19.63002 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Cebu City, N/A, Philippines, Philippines
1245.19.63004 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Manila, Philippines, Philippines
1245.19.63003 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Davao City, N/A, Philippines, Philippines
1245.19.63005 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Pasig City, Philippines, Philippines
1245.19.66004 Boehringer Ingelheim Investigational Site
🇹ðŸ‡Udon Thani, Thailand, Thailand
1245.19.63001 Boehringer Ingelheim Investigational Site
🇵ðŸ‡San Juan City, Philippines, Philippines
1245.19.66003 Boehringer Ingelheim Investigational Site
🇹ðŸ‡Saimai, Thailand
1245.19.75002 Boehringer Ingelheim Investigational Site
🇺🇦Dnepropetrovsk, Ukraine
1245.19.75001 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1245.19.75005 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1245.19.75004 Boehringer Ingelheim Investigational Site
🇺🇦Vinnitsa, Ukraine
1245.19.20059 Boehringer Ingelheim Investigational Site
🇨🇦Fort Erie, Ontario, Canada
1245.19.10033 Boehringer Ingelheim Investigational Site
🇺🇸Chattanooga, Tennessee, United States
1245.19.75003 Boehringer Ingelheim Investigational Site
🇺🇦Vinnytsya, Ukraine
1245.19.10046 Boehringer Ingelheim Investigational Site
🇺🇸Tempe, Arizona, United States
1245.19.20062 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1245.19.20047 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada