A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01649297
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 983
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description empagliflozin (low dose qd) empagliflozin (low dose qd) Patients receive Empagliflozin low dose once daily empagliflozin (low dose bid) Placebo Patients receive Empagliflozin low dose split twice daily Placebo Placebo Patients receive placebo matching Empagliflozin empagliflozin (low dose qd) Placebo Patients receive Empagliflozin low dose once daily empagliflozin (low dose bid) empagliflozin (low dose bid) Patients receive Empagliflozin low dose split twice daily empagliflozin (high dose qd) Placebo Patients receive Empagliflozin high dose once daily empagliflozin (high dose qd) Empagliflozin (high dose qd) Patients receive Empagliflozin high dose once daily empagliflozin (high dose bid) empagliflozin (high dose bid) Patients receive Empagliflozin high dose split twice daily empagliflozin (high dose bid) Placebo Patients receive Empagliflozin high dose split twice daily
- Primary Outcome Measures
Name Time Method HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 Baseline and 16 weeks Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
- Secondary Outcome Measures
Name Time Method Fasting Plasma Glucose (FPG) Change From Baseline at Week 16 Baseline and 16 weeks Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
Trial Locations
- Locations (139)
1276.10.11049 Boehringer Ingelheim Investigational Site
🇺🇸Jonesboro, Arkansas, United States
1276.10.11033 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1276.10.11012 Boehringer Ingelheim Investigational Site
🇺🇸Norwalk, Connecticut, United States
1276.10.11048 Boehringer Ingelheim Investigational Site
🇺🇸Sterling Heights, Michigan, United States
1276.10.11042 Boehringer Ingelheim Investigational Site
🇺🇸Corpus Christi, Texas, United States
1276.10.11040 Boehringer Ingelheim Investigational Site
🇺🇸Lomita, California, United States
1276.10.11036 Boehringer Ingelheim Investigational Site
🇺🇸Florence, Alabama, United States
1276.10.11002 Boehringer Ingelheim Investigational Site
🇺🇸Rancho Cucamonga, California, United States
1276.10.11015 Boehringer Ingelheim Investigational Site
🇺🇸West Hills, California, United States
1276.10.11009 Boehringer Ingelheim Investigational Site
🇺🇸Oakland Park, Florida, United States
1276.10.11035 Boehringer Ingelheim Investigational Site
🇺🇸North Myrtle Beach, North Carolina, United States
1276.10.11031 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1276.10.11034 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1276.10.37201 Boehringer Ingelheim Investigational Site
🇪🇪Tallinn, Estonia
1276.10.49002 Boehringer Ingelheim Investigational Site
🇩🇪Nürnberg, Germany
1276.10.39007 Boehringer Ingelheim Investigational Site
🇮🇹Catanzaro, Italy
1276.10.39005 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1276.10.37101 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
1276.10.39008 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1276.10.64001 Boehringer Ingelheim Investigational Site
🇳🇿Christchurch, New Zealand
1276.10.48006 Boehringer Ingelheim Investigational Site
🇵🇱Katowice, Poland
1276.10.48004 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1276.10.50201 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala Ciudad, Guatemala
1276.10.37003 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
1276.10.20004 Boehringer Ingelheim Investigational Site
🇨🇦Drummondville, Quebec, Canada
1276.10.38001 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1276.10.37203 Boehringer Ingelheim Investigational Site
🇪🇪Pärnu, Estonia
1276.10.50203 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala Ciudad, Guatemala
1276.10.50204 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala Ciudad, Guatemala
1276.10.37103 Boehringer Ingelheim Investigational Site
🇱🇻Tukums, Latvia
1276.10.38005 Boehringer Ingelheim Investigational Site
🇺🇦Kyiv, Ukraine
1276.10.99502 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1276.10.50202 Boehringer Ingelheim Investigational Site
🇬🇹Quetzaltenango Ciudad, Guatemala
1276.10.37102 Boehringer Ingelheim Investigational Site
🇱🇻Daugavpils, Latvia
1276.10.37004 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
1276.10.52001 Boehringer Ingelheim Investigational Site
🇲🇽Ciudad de Mexico, Mexico
1276.10.52004 Boehringer Ingelheim Investigational Site
🇲🇽Tijuana, Mexico
1276.10.48005 Boehringer Ingelheim Investigational Site
🇵🇱Katowice, Poland
1276.10.20008 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1276.10.11003 Boehringer Ingelheim Investigational Site
🇺🇸Johnson City, Tennessee, United States
1276.10.20003 Boehringer Ingelheim Investigational Site
🇨🇦Point Claire, Quebec, Canada
1276.10.70002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1276.10.70004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1276.10.70007 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1276.10.37204 Boehringer Ingelheim Investigational Site
🇪🇪Viljandi County, Estonia
1276.10.11058 Boehringer Ingelheim Investigational Site
🇺🇸Jackson, Mississippi, United States
1276.10.11047 Boehringer Ingelheim Investigational Site
🇺🇸Waterbury, Connecticut, United States
1276.10.37202 Boehringer Ingelheim Investigational Site
🇪🇪Tallinn, Estonia
1276.10.99503 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1276.10.99505 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1276.10.37104 Boehringer Ingelheim Investigational Site
🇱🇻Ogre, Latvia
1276.10.52003 Boehringer Ingelheim Investigational Site
🇲🇽Durango, Mexico
1276.10.48001 Boehringer Ingelheim Investigational Site
🇵🇱Bialystok, Poland
1276.10.11055 Boehringer Ingelheim Investigational Site
🇺🇸Edison, New Jersey, United States
1276.10.20009 Boehringer Ingelheim Investigational Site
🇨🇦Victoriaville, Quebec, Canada
1276.10.70003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1276.10.70005 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1276.10.37002 Boehringer Ingelheim Investigational Site
🇱🇹Klaipeda, Lithuania
1276.10.48003 Boehringer Ingelheim Investigational Site
🇵🇱Warszawa, Poland
1276.10.37001 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
1276.10.52002 Boehringer Ingelheim Investigational Site
🇲🇽Ciudad de Mexico, Mexico
1276.10.52005 Boehringer Ingelheim Investigational Site
🇲🇽Pachuca, Mexico
1276.10.48002 Boehringer Ingelheim Investigational Site
🇵🇱Bialystok, Poland
1276.10.48008 Boehringer Ingelheim Investigational Site
🇵🇱Gizycko, Poland
1276.10.38007 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
1276.10.70001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1276.10.70008 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1276.10.38002 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
1276.10.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1276.10.39002 Boehringer Ingelheim Investigational Site
🇮🇹Napoli, Italy
1276.10.11050 Boehringer Ingelheim Investigational Site
🇺🇸Sacramento, California, United States
1276.10.11010 Boehringer Ingelheim Investigational Site
🇺🇸Bradenton, Florida, United States
1276.10.11005 Boehringer Ingelheim Investigational Site
🇺🇸Davie, Florida, United States
1276.10.11001 Boehringer Ingelheim Investigational Site
🇺🇸Bangor, Maine, United States
1276.10.11011 Boehringer Ingelheim Investigational Site
🇺🇸Brooklyn, New York, United States
1276.10.11051 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1276.10.11041 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1276.10.11044 Boehringer Ingelheim Investigational Site
🇺🇸Palm Harbor, Florida, United States
1276.10.20010 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1276.10.39001 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1276.10.49003 Boehringer Ingelheim Investigational Site
🇩🇪Rehlingen-Siersburg, Germany
1276.10.61002 Boehringer Ingelheim Investigational Site
🇦🇺Wollongong, New South Wales, Australia
1276.10.49005 Boehringer Ingelheim Investigational Site
🇩🇪Essen, Germany
1276.10.11022 Boehringer Ingelheim Investigational Site
🇺🇸Fleetwood, Pennsylvania, United States
1276.10.20006 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1276.10.20001 Boehringer Ingelheim Investigational Site
🇨🇦Brampton, Ontario, Canada
1276.10.11026 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1276.10.61001 Boehringer Ingelheim Investigational Site
🇦🇺Box Hill, Victoria, Australia
1276.10.11013 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1276.10.11029 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1276.10.11024 Boehringer Ingelheim Investigational Site
🇺🇸Spokane, Washington, United States
1276.10.11028 Boehringer Ingelheim Investigational Site
🇺🇸Pearland, Texas, United States
1276.10.11016 Boehringer Ingelheim Investigational Site
🇺🇸Port Orchard, Washington, United States
1276.10.20007 Boehringer Ingelheim Investigational Site
🇨🇦Corunna, Ontario, Canada
1276.10.33003 Boehringer Ingelheim Investigational Site
🇫🇷Bischheim, France
1276.10.33014 Boehringer Ingelheim Investigational Site
🇫🇷Bourges, France
1276.10.39004 Boehringer Ingelheim Investigational Site
🇮🇹Arenzano (GE), Italy
1276.10.33002 Boehringer Ingelheim Investigational Site
🇫🇷Aire sur l'Adour, France
1276.10.33009 Boehringer Ingelheim Investigational Site
🇫🇷Bourg des Comptes, France
1276.10.33006 Boehringer Ingelheim Investigational Site
🇫🇷Saint Vinecnt de Tyrosse, France
1276.10.49007 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1276.10.33004 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1276.10.99501 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1276.10.99506 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1276.10.33008 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1276.10.33011 Boehringer Ingelheim Investigational Site
🇫🇷Segre, France
1276.10.49004 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
1276.10.33001 Boehringer Ingelheim Investigational Site
🇫🇷Mont de Marsan, France
1276.10.49006 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1276.10.49001 Boehringer Ingelheim Investigational Site
🇩🇪Aschaffenburg, Germany
1276.10.33007 Boehringer Ingelheim Investigational Site
🇫🇷Broglie, France
1276.10.99504 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1276.10.39003 Boehringer Ingelheim Investigational Site
🇮🇹Bologna, Italy
1276.10.39009 Boehringer Ingelheim Investigational Site
🇮🇹Catanzaro, Italy
1276.10.34003 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat, Spain
1276.10.34002 Boehringer Ingelheim Investigational Site
🇪🇸Les Borges del Camp, Spain
1276.10.27002 Boehringer Ingelheim Investigational Site
🇿🇦Somerset West, South Africa
1276.10.50205 Boehringer Ingelheim Investigational Site
🇬🇹Guatemala Ciudad, Guatemala
1276.10.39006 Boehringer Ingelheim Investigational Site
🇮🇹Palermo, Italy
1276.10.34004 Boehringer Ingelheim Investigational Site
🇪🇸Sant Adria del Besos, Spain
1276.10.64002 Boehringer Ingelheim Investigational Site
🇳🇿Greenlane East Auckland NZ, New Zealand
1276.10.27005 Boehringer Ingelheim Investigational Site
🇿🇦Pretoria, South Africa
1276.10.27006 Boehringer Ingelheim Investigational Site
🇿🇦Plumstead, Cape Town, South Africa
1276.10.27004 Boehringer Ingelheim Investigational Site
🇿🇦Paarl, South Africa
1276.10.70009 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1276.10.27003 Boehringer Ingelheim Investigational Site
🇿🇦Parow, South Africa
1276.10.27001 Boehringer Ingelheim Investigational Site
🇿🇦Pretoria, South Africa
1276.10.34006 Boehringer Ingelheim Investigational Site
🇪🇸Vic, Spain
1276.10.34001 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat, Spain
1276.10.34005 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1276.10.11030 Boehringer Ingelheim Investigational Site
🇺🇸Dunwoody, Georgia, United States
1276.10.11018 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
1276.10.11043 Boehringer Ingelheim Investigational Site
🇺🇸Dayton, Ohio, United States
1276.10.11027 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1276.10.11004 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
1276.10.11017 Boehringer Ingelheim Investigational Site
🇺🇸Kettering, Ohio, United States
1276.10.11020 Boehringer Ingelheim Investigational Site
🇺🇸Elwood, Indiana, United States
1276.10.20002 Boehringer Ingelheim Investigational Site
🇨🇦Bathurst, New Brunswick, Canada
1276.10.20005 Boehringer Ingelheim Investigational Site
🇨🇦Surrey, British Columbia, Canada