Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01734785
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 607
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linagliptin Linagliptin 5 mg once daily Linagliptin Empagliflozin placebo + Linagliptin placebo 5 mg once daily Empagliflozin + Linagliptin low dose Empagliflozin + Linagliptin 1 tablet once daily Empagliflozin + Linagliptin high dose Empagliflozin + Linagliptin 1 tablet once daily
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment Baseline and 24 weeks Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
- Secondary Outcome Measures
Name Time Method Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment Baseline and 24 weeks Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.
Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment. Baseline and 24 weeks Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.
Trial Locations
- Locations (90)
1275.9.34011 Boehringer Ingelheim Investigational Site
🇪🇸A Coruña, Spain
1275.9.34009 Boehringer Ingelheim Investigational Site
🇪🇸Alicante, Spain
1275.9.47006 Boehringer Ingelheim Investigational Site
🇳🇴Svelvik, Norway
1275.9.34005 Boehringer Ingelheim Investigational Site
🇪🇸BadÃa Del Vallès - Barcelona, Spain
1275.9.01013 Boehringer Ingelheim Investigational Site
🇺🇸Gulf Shores, Alabama, United States
1275.9.01009 Boehringer Ingelheim Investigational Site
🇺🇸Norwalk, California, United States
1275.9.01015 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1275.9.01017 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1275.9.01011 Boehringer Ingelheim Investigational Site
🇺🇸Northglenn, Colorado, United States
1275.9.01010 Boehringer Ingelheim Investigational Site
🇺🇸Coral Gables, Florida, United States
1275.9.01004 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1275.9.01006 Boehringer Ingelheim Investigational Site
🇺🇸Oldsmar, Florida, United States
1275.9.01001 Boehringer Ingelheim Investigational Site
🇺🇸Palm Coast, Florida, United States
1275.9.01027 Boehringer Ingelheim Investigational Site
🇺🇸Port Orange, Florida, United States
1275.9.01029 Boehringer Ingelheim Investigational Site
🇺🇸Blue Ridge, Georgia, United States
1275.9.01003 Boehringer Ingelheim Investigational Site
🇺🇸Marietta, Georgia, United States
1275.9.01022 Boehringer Ingelheim Investigational Site
🇺🇸Savannah, Georgia, United States
1275.9.01031 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1275.9.01019 Boehringer Ingelheim Investigational Site
🇺🇸Methuen, Massachusetts, United States
1275.9.01024 Boehringer Ingelheim Investigational Site
🇺🇸Troy, Michigan, United States
1275.9.01023 Boehringer Ingelheim Investigational Site
🇺🇸Saint Louis, Missouri, United States
1275.9.01002 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
1275.9.01007 Boehringer Ingelheim Investigational Site
🇺🇸Newington, New Hampshire, United States
1275.9.01016 Boehringer Ingelheim Investigational Site
🇺🇸Asheboro, North Carolina, United States
1275.9.01025 Boehringer Ingelheim Investigational Site
🇺🇸Burlington, North Carolina, United States
1275.9.01014 Boehringer Ingelheim Investigational Site
🇺🇸Shelby, North Carolina, United States
1275.9.01028 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1275.9.01018 Boehringer Ingelheim Investigational Site
🇺🇸Dayton, Ohio, United States
1275.9.01005 Boehringer Ingelheim Investigational Site
🇺🇸Corvallis, Oregon, United States
1275.9.01032 Boehringer Ingelheim Investigational Site
🇺🇸Corpus Christi, Texas, United States
1275.9.01030 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1275.9.01021 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1275.9.61009 Boehringer Ingelheim Investigational Site
🇦🇺Liverpool, New South Wales, Australia
1275.9.61001 Boehringer Ingelheim Investigational Site
🇦🇺St Leonards, New South Wales, Australia
1275.9.61003 Boehringer Ingelheim Investigational Site
🇦🇺Carina Heights, Queensland, Australia
1275.9.61002 Boehringer Ingelheim Investigational Site
🇦🇺Herston, Queensland, Australia
1275.9.61006 Boehringer Ingelheim Investigational Site
🇦🇺Malvern, Victoria, Australia
1275.9.61007 Boehringer Ingelheim Investigational Site
🇦🇺Nedlands, Western Australia, Australia
1275.9.55002 Boehringer Ingelheim Investigational Site
🇧🇷Brasilia, Brazil
1275.9.55005 Boehringer Ingelheim Investigational Site
🇧🇷Goiania, Brazil
1275.9.55001 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
1275.9.55003 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
1275.9.55004 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
1275.9.01101 Boehringer Ingelheim Investigational Site
🇨🇦Burnaby, British Columbia, Canada
1275.9.01103 Boehringer Ingelheim Investigational Site
🇨🇦Victoria, British Columbia, Canada
1275.9.01105 Boehringer Ingelheim Investigational Site
🇨🇦Cornwall, Ontario, Canada
1275.9.01106 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1275.9.01104 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1275.9.01102 Boehringer Ingelheim Investigational Site
🇨🇦Waterloo, Ontario, Canada
1275.9.34008 Boehringer Ingelheim Investigational Site
🇸🇻Barcelona, El Salvador
1275.9.33006 Boehringer Ingelheim Investigational Site
🇫🇷Bourg des Comptes, France
1275.9.33008 Boehringer Ingelheim Investigational Site
🇫🇷Dessenheim, France
1275.9.33003 Boehringer Ingelheim Investigational Site
🇫🇷La Riche, France
1275.9.33012 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1275.9.33002 Boehringer Ingelheim Investigational Site
🇫🇷Saint Avertin, France
1275.9.33005 Boehringer Ingelheim Investigational Site
🇫🇷Savonnieres, France
1275.9.33004 Boehringer Ingelheim Investigational Site
🇫🇷Tours, France
1275.9.82006 Boehringer Ingelheim Investigational Site
🇰🇷Daejeon, Korea, Republic of
1275.9.82009 Boehringer Ingelheim Investigational Site
🇰🇷Deagu, Korea, Republic of
1275.9.82002 Boehringer Ingelheim Investigational Site
🇰🇷Goyang, Korea, Republic of
1275.9.82004 Boehringer Ingelheim Investigational Site
🇰🇷Seongnam, Korea, Republic of
1275.9.82001 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1275.9.82005 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1275.9.82007 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1275.9.82008 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1275.9.82010 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1275.9.64005 Boehringer Ingelheim Investigational Site
🇳🇿Auckland, New Zealand, New Zealand
1275.9.64006 Boehringer Ingelheim Investigational Site
🇳🇿Auckland, New Zealand, New Zealand
1275.9.64008 Boehringer Ingelheim Investigational Site
🇳🇿Birkenhead Auckland, New Zealand
1275.9.64007 Boehringer Ingelheim Investigational Site
🇳🇿Christchurch Central, New Zealand
1275.9.64004 Boehringer Ingelheim Investigational Site
🇳🇿Christchurch, New Zealand, New Zealand
1275.9.64002 Boehringer Ingelheim Investigational Site
🇳🇿Otahuhu Auckland, New Zealand
1275.9.64001 Boehringer Ingelheim Investigational Site
🇳🇿Takapuna Auckland, New Zealand
1275.9.64003 Boehringer Ingelheim Investigational Site
🇳🇿Tauranga, New Zealand, New Zealand
1275.9.47001 Boehringer Ingelheim Investigational Site
🇳🇴Bergen, Norway
1275.9.47002 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1275.9.47003 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1275.9.47007 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1275.9.34001 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1275.9.34003 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1275.9.34004 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1275.9.34002 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1275.9.34010 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1275.9.34006 Boehringer Ingelheim Investigational Site
🇪🇸Vic, Spain
1275.9.88606 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1275.9.88607 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1275.9.88602 Boehringer Ingelheim Investigational Site
🇨🇳New Taipei, Taiwan
1275.9.88603 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
1275.9.88604 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
1275.9.88605 Boehringer Ingelheim Investigational Site
🇨🇳Tainan, Taiwan