Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01778049
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 708
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin 10 mg dose BI 10773 Empagliflozin open label treatment period Placebo add on 10 mg dose BI 10773 / BI 1356 Placebo Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in Empagliflozin/Linagliptin 25/5 mg Dose BI 10773 / BI 1356 Empagliflozin / Linagliptin 25/5 mg Dose FDC active Empagliflozin/Linagliptin 25/5 mg Dose BI 10773 Placebo Empagliflozin / Linagliptin 25/5 mg Dose FDC active Empagliflozin/Linagliptin 10/5 mg Dose. BI 10773 / BI 1356 Placebo Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo Empagliflozin/Linagliptin 10/5 mg Dose BI 10773 Placebo Empagliflozin / Linagliptin 10/5 mg Dose FDC active Empagliflozin/Linagliptin 10/5 mg Dose BI 10773 / BI 1356 Empagliflozin / Linagliptin 10/5 mg Dose FDC active Empagliflozin/Linagliptin 25/5 mg Dose. BI 10773 / BI 1356 Placebo Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo Placebo add on 25 mg dose BI 10773 / BI 1356 Placebo Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in Placebo add on 10 mg dose BI 10773 Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in Empagliflozin 25 mg dose BI 10773 Empagliflozin open label treatment period Empagliflozin/Linagliptin 10/5 mg Dose. BI 10773 Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo Empagliflozin/Linagliptin 25/5 mg Dose. BI 10773 Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo Placebo add on 25 mg dose BI 10773 Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
- Primary Outcome Measures
Name Time Method Change From Baseline of HbA1c After 24 Weeks of Treatment. Baseline and 24 weeks Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.
Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.
- Secondary Outcome Measures
Name Time Method Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks. Baseline and 24 weeks Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.
Trial Locations
- Locations (114)
1275.10.35104 Boehringer Ingelheim Investigational Site
🇵🇹Cantanhede, Portugal
1275.10.35112 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
1275.10.38002 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1275.10.38004 Boehringer Ingelheim Investigational Site
🇺🇦Lviv, Ukraine
1275.10.38001 Boehringer Ingelheim Investigational Site
🇺🇦Vinnitsa, Ukraine
1275.10.38005 Boehringer Ingelheim Investigational Site
🇺🇦Zhytomyr, Ukraine
1275.10.01017 Boehringer Ingelheim Investigational Site
🇺🇸Conyers, Georgia, United States
1275.10.02004 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1275.10.54011 Boehringer Ingelheim Investigational Site
🇦🇷Córdoba, Argentina
1275.10.01022 Boehringer Ingelheim Investigational Site
🇺🇸Pittsburgh, Pennsylvania, United States
1275.10.54004 Boehringer Ingelheim Investigational Site
🇦🇷Salta, Argentina
1275.10.01008 Boehringer Ingelheim Investigational Site
🇺🇸Huntington Beach, California, United States
1275.10.01016 Boehringer Ingelheim Investigational Site
🇺🇸Snellville, Georgia, United States
1275.10.01012 Boehringer Ingelheim Investigational Site
🇺🇸Avon, Indiana, United States
1275.10.01003 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1275.10.01011 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1275.10.01009 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
1275.10.54010 Boehringer Ingelheim Investigational Site
🇦🇷Zarate, Argentina
1275.10.01019 Boehringer Ingelheim Investigational Site
🇺🇸Chino, California, United States
1275.10.02003 Boehringer Ingelheim Investigational Site
🇨🇦Chilliwack, British Columbia, Canada
1275.10.01002 Boehringer Ingelheim Investigational Site
🇺🇸Sylmar, California, United States
1275.10.01014 Boehringer Ingelheim Investigational Site
🇺🇸North Richland Hills, Texas, United States
1275.10.39015 Boehringer Ingelheim Investigational Site
🇮🇹Olbia (OT), Italy
1275.10.02005 Boehringer Ingelheim Investigational Site
🇨🇦Moncton, New Brunswick, Canada
1275.10.01024 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1275.10.02010 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1275.10.54002 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1275.10.54008 Boehringer Ingelheim Investigational Site
🇦🇷Cordoba, Argentina
1275.10.01023 Boehringer Ingelheim Investigational Site
🇺🇸Oviedo, Florida, United States
1275.10.01006 Boehringer Ingelheim Investigational Site
🇺🇸Tamarac, Florida, United States
1275.10.01025 Boehringer Ingelheim Investigational Site
🇺🇸Virginia Beach, Virginia, United States
1275.10.01013 Boehringer Ingelheim Investigational Site
🇺🇸Muncie, Indiana, United States
1275.10.49010 Boehringer Ingelheim Investigational Site
🇩🇪Lübeck, Germany
1275.10.01020 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
1275.10.01010 Boehringer Ingelheim Investigational Site
🇺🇸Elkton, Maryland, United States
1275.10.54013 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1275.10.54003 Boehringer Ingelheim Investigational Site
🇦🇷Godoy Cruz, Mendoza, Argentina
1275.10.02001 Boehringer Ingelheim Investigational Site
🇨🇦Red Deer, Alberta, Canada
1275.10.61001 Boehringer Ingelheim Investigational Site
🇦🇺Heidelberg Heights, Victoria, Australia
1275.10.54007 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1275.10.01015 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
1275.10.38007 Boehringer Ingelheim Investigational Site
🇺🇦Dnipropetrovs'k, Ukraine
1275.10.54006 Boehringer Ingelheim Investigational Site
🇦🇷Cordoba, Argentina
1275.10.61008 Boehringer Ingelheim Investigational Site
🇦🇺Cardiff, New South Wales, Australia
1275.10.34005 Boehringer Ingelheim Investigational Site
🇪🇸Tarragona, Spain
1275.10.02012 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1275.10.34002 Boehringer Ingelheim Investigational Site
🇪🇸Sabadell, Spain
1275.10.38006 Boehringer Ingelheim Investigational Site
🇺🇦Chernivtsi, Ukraine
1275.10.49016 Boehringer Ingelheim Investigational Site
🇩🇪Elsterwerda, Germany
1275.10.35103 Boehringer Ingelheim Investigational Site
🇵🇹Sandim, Portugal
1275.10.02008 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1275.10.01018 Boehringer Ingelheim Investigational Site
🇺🇸Draper, Utah, United States
1275.10.54009 Boehringer Ingelheim Investigational Site
🇦🇷Mar del Plata, Argentina
1275.10.54005 Boehringer Ingelheim Investigational Site
🇦🇷Caba, Argentina
1275.10.01001 Boehringer Ingelheim Investigational Site
🇺🇸Stevensville, Michigan, United States
1275.10.01005 Boehringer Ingelheim Investigational Site
🇺🇸Bismarck, North Dakota, United States
1275.10.54012 Boehringer Ingelheim Investigational Site
🇦🇷Caba, Argentina
1275.10.54001 Boehringer Ingelheim Investigational Site
🇦🇷San Isidro, Argentina
1275.10.61009 Boehringer Ingelheim Investigational Site
🇦🇺Mirrabooka, Western Australia, Australia
1275.10.61002 Boehringer Ingelheim Investigational Site
🇦🇺East Ringwood, Victoria, Australia
1275.10.02013 Boehringer Ingelheim Investigational Site
🇨🇦Burlington, Ontario, Canada
1275.10.02002 Boehringer Ingelheim Investigational Site
🇨🇦Strathroy, Ontario, Canada
1275.10.02011 Boehringer Ingelheim Investigational Site
🇨🇦Drummondville, Quebec, Canada
1275.10.49007 Boehringer Ingelheim Investigational Site
🇩🇪Asslar, Germany
1275.10.49008 Boehringer Ingelheim Investigational Site
🇩🇪Kiel Kronshagen, Germany
1275.10.49013 Boehringer Ingelheim Investigational Site
🇩🇪St. Ingbert/Oberwürzbach, Germany
1275.10.49001 Boehringer Ingelheim Investigational Site
🇩🇪Unterschneidheim, Germany
1275.10.39009 Boehringer Ingelheim Investigational Site
🇮🇹Catania, Italy
1275.10.39005 Boehringer Ingelheim Investigational Site
🇮🇹Ancona, Italy
1275.10.39006 Boehringer Ingelheim Investigational Site
🇮🇹Catania, Italy
1275.10.39014 Boehringer Ingelheim Investigational Site
🇮🇹Catania, Italy
1275.10.39007 Boehringer Ingelheim Investigational Site
🇮🇹Latina, Italy
1275.10.39012 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1275.10.39013 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1275.10.39016 Boehringer Ingelheim Investigational Site
🇮🇹Orbassano (TO), Italy
1275.10.39004 Boehringer Ingelheim Investigational Site
🇮🇹Palermo, Italy
1275.10.39003 Boehringer Ingelheim Investigational Site
🇮🇹Pistoia, Italy
1275.10.39010 Boehringer Ingelheim Investigational Site
🇮🇹Siena, Italy
1275.10.39008 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1275.10.39011 Boehringer Ingelheim Investigational Site
🇮🇹Terni, Italy
1275.10.39001 Boehringer Ingelheim Investigational Site
🇮🇹Sesto San Giovanni (MI), Italy
1275.10.35105 Boehringer Ingelheim Investigational Site
🇵🇹Tornada, Portugal
1275.10.07004 Boehringer Ingelheim Investigational Site
🇷🇺Chelyabinsk, Russian Federation
1275.10.07002 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
1275.10.07003 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1275.10.07001 Boehringer Ingelheim Investigational Site
🇷🇺Saratov, Russian Federation
1275.10.07005 Boehringer Ingelheim Investigational Site
🇷🇺Saratov, Russian Federation
1275.10.34003 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1275.10.34004 Boehringer Ingelheim Investigational Site
🇪🇸Canet de Mar, Spain
1275.10.34009 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat (Barcelona), Spain
1275.10.34012 Boehringer Ingelheim Investigational Site
🇪🇸La Roca del Vallès, Spain
1275.10.34006 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1275.10.34010 Boehringer Ingelheim Investigational Site
🇪🇸Malaga, Spain
1275.10.34011 Boehringer Ingelheim Investigational Site
🇪🇸Mataró, Spain
1275.10.34001 Boehringer Ingelheim Investigational Site
🇪🇸Málaga, Spain
1275.10.34013 Boehringer Ingelheim Investigational Site
🇪🇸Pineda de Mar, Spain
1275.10.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1275.10.01021 Boehringer Ingelheim Investigational Site
🇺🇸Union, South Carolina, United States
1275.10.02007 Boehringer Ingelheim Investigational Site
🇨🇦Sudbury, Ontario, Canada
1275.10.02006 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1275.10.49005 Boehringer Ingelheim Investigational Site
🇩🇪Hatten, Germany
1275.10.01007 Boehringer Ingelheim Investigational Site
🇺🇸Salisbury, North Carolina, United States
1275.10.49006 Boehringer Ingelheim Investigational Site
🇩🇪Pirna, Germany
1275.10.49014 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1275.10.49012 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1275.10.49004 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
1275.10.49003 Boehringer Ingelheim Investigational Site
🇩🇪Münster, Germany
1275.10.49015 Boehringer Ingelheim Investigational Site
🇩🇪Wangen, Germany
1275.10.07006 Boehringer Ingelheim Investigational Site
🇷🇺Saint-Petersburg, Russian Federation
1275.10.34008 Boehringer Ingelheim Investigational Site
🇪🇸Centelles, Spain
1275.10.34014 Boehringer Ingelheim Investigational Site
🇸🇻Ávila, El Salvador
1275.10.02009 Boehringer Ingelheim Investigational Site
🇨🇦Coquitlam, British Columbia, Canada
1275.10.35108 Boehringer Ingelheim Investigational Site
🇵🇹Valadares, Portugal
1275.10.35101 Boehringer Ingelheim Investigational Site
🇵🇹Vila Nova de Gaia, Portugal