Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01012037
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 491
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description linagliptin medium dose linagliptin medium dose linagliptin medium dose once daily linagliptin low dose linagliptin low dose linagliptin low dose twice daily placebo placebo placebo matching linagliptin
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline at Week 12 Baseline and week 12 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.
- Secondary Outcome Measures
Name Time Method The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment 12 weeks Percentage of those patients with baseline HbA1c \>= 6.5% who had HbA1c \< 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis Baseline and week 6 Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis Baseline and week 12 Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
FPG Change From Baseline at Week 12 Baseline and week 12 Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.
FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis Baseline and week 6 Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis Baseline and week 12 Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12 Week 12 Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.
Percentage of Patients With Rescue Therapy 12 weeks Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.
The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment 12 weeks Percentage of those patients with baseline HbA1c \>= 7.0% who had HbA1c \< 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
Trial Locations
- Locations (84)
1218.62.11007 Boehringer Ingelheim Investigational Site
🇨🇦Burnaby, British Columbia, Canada
1218.62.32009 Boehringer Ingelheim Investigational Site
🇧🇪Kumtich, Belgium
1218.62.31001 Boehringer Ingelheim Investigational Site
🇳🇱Oude Pekela, Netherlands
1218.62.60003 Boehringer Ingelheim Investigational Site
🇲🇾Putrajaya, Malaysia
1218.62.60004 Boehringer Ingelheim Investigational Site
🇲🇾Seremban, Malaysia
1218.62.31007 Boehringer Ingelheim Investigational Site
🇳🇱Almere, Netherlands
1218.62.31005 Boehringer Ingelheim Investigational Site
🇳🇱Etten-Leur, Netherlands
1218.62.31002 Boehringer Ingelheim Investigational Site
🇳🇱Lieshout, Netherlands
1218.62.31008 Boehringer Ingelheim Investigational Site
🇳🇱Voerendaal, Netherlands
1218.62.31009 Boehringer Ingelheim Investigational Site
🇳🇱Wildervank, Netherlands
1218.62.11004 Boehringer Ingelheim Investigational Site
🇨🇦Markham, Ontario, Canada
1218.62.32003 Boehringer Ingelheim Investigational Site
🇧🇪De Pinte, Belgium
1218.62.39004 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1218.62.34001 Boehringer Ingelheim Investigational Site
🇪🇸Palma (Mallorca), Spain
1218.62.82001 Boehringer Ingelheim Investigational Site
🇰🇷Suwon, Korea, Republic of
1218.62.32005 Boehringer Ingelheim Investigational Site
🇧🇪Massemen-Wetteren, Belgium
1218.62.60001 Boehringer Ingelheim Investigational Site
🇲🇾Kelantan Kota Bahru, Malaysia
1218.62.31004 Boehringer Ingelheim Investigational Site
🇳🇱Breezerveld, Netherlands
1218.62.3306A Boehringer Ingelheim Investigational Site
🇫🇷Bourg des cptes, France
1218.62.60002 Boehringer Ingelheim Investigational Site
🇲🇾Penang, Malaysia
1218.62.39012 Boehringer Ingelheim Investigational Site
🇮🇹Ravenna, Italy
1218.62.34007 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1218.62.34003 Boehringer Ingelheim Investigational Site
🇪🇸Badia del Vallés (Barcelona), Spain
1218.62.82003 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, Korea, Republic of
1218.62.82004 Boehringer Ingelheim Investigational Site
🇰🇷Pucheon, Korea, Republic of
1218.62.39009 Boehringer Ingelheim Investigational Site
🇮🇹Gissi (CH), Italy
1218.62.39001 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
1218.62.39007 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1218.62.82005 Boehringer Ingelheim Investigational Site
🇰🇷Goyang, Korea, Republic of
1218.62.82006 Boehringer Ingelheim Investigational Site
🇰🇷Goyang, Korea, Republic of
1218.62.34005 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1218.62.34006 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1218.62.60005 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Lumpur, Malaysia
1218.62.39003 Boehringer Ingelheim Investigational Site
🇮🇹Palermo, Italy
1218.62.3303D Boehringer Ingelheim Investigational Site
🇫🇷Bugeat, France
1218.62.34002 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat (Barcelona), Spain
1218.62.34008 Boehringer Ingelheim Investigational Site
🇪🇸Palma de Mallorca, Spain
1218.62.82002 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1218.62.39006 Boehringer Ingelheim Investigational Site
🇮🇹Catania, Italy
1218.62.39002 Boehringer Ingelheim Investigational Site
🇮🇹Pordenone, Italy
1218.62.39011 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1218.62.11005 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1218.62.11006 Boehringer Ingelheim Investigational Site
🇨🇦Halifax, Nova Scotia, Canada
1218.62.3304B Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1218.62.32008 Boehringer Ingelheim Investigational Site
🇧🇪Kortenaken, Belgium
1218.62.32004 Boehringer Ingelheim Investigational Site
🇧🇪Natoye, Belgium
1218.62.32007 Boehringer Ingelheim Investigational Site
🇧🇪Sint-Job-in't-Goor, Belgium
1218.62.32002 Boehringer Ingelheim Investigational Site
🇧🇪Tessenderlo, Belgium
1218.62.11012 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1218.62.32006 Boehringer Ingelheim Investigational Site
🇧🇪Wilsele, Belgium
1218.62.11011 Boehringer Ingelheim Investigational Site
🇨🇦St. John's, Newfoundland and Labrador, Canada
1218.62.11001 Boehringer Ingelheim Investigational Site
🇨🇦Barrie, Ontario, Canada
1218.62.11003 Boehringer Ingelheim Investigational Site
🇨🇦Brampton, Ontario, Canada
1218.62.11008 Boehringer Ingelheim Investigational Site
🇨🇦Smiths Falls, Ontario, Canada
1218.62.11013 Boehringer Ingelheim Investigational Site
🇨🇦Strathroy, Ontario, Canada
1218.62.11014 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1218.62.11002 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1218.62.11010 Boehringer Ingelheim Investigational Site
🇨🇦Charlottetown, Prince Edward Island, Canada
1218.62.3303C Boehringer Ingelheim Investigational Site
🇫🇷Bort les Orgues, France
1218.62.11009 Boehringer Ingelheim Investigational Site
🇨🇦Point Claire, Quebec, Canada
1218.62.3302H Boehringer Ingelheim Investigational Site
🇫🇷Corsept, France
1218.62.3308A Boehringer Ingelheim Investigational Site
🇫🇷Derval, France
1218.62.3302B Boehringer Ingelheim Investigational Site
🇫🇷La Chapelle sur Erdre, France
1218.62.3304A Boehringer Ingelheim Investigational Site
🇫🇷Levallois Perret, France
1218.62.3305A Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1218.62.3305B Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1218.62.3305G Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1218.62.3305H Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1218.62.3301A Boehringer Ingelheim Investigational Site
🇫🇷Nantes Cedex 1, France
1218.62.3302A Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
1218.62.3304D Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1218.62.3305F Boehringer Ingelheim Investigational Site
🇫🇷Roquevaire, France
1218.62.3303A Boehringer Ingelheim Investigational Site
🇫🇷Rosiers d'Egletons, France
1218.62.3305I Boehringer Ingelheim Investigational Site
🇫🇷Roquevaire, France
1218.62.3303H Boehringer Ingelheim Investigational Site
🇫🇷Sainte Fortunade, France
1218.62.3302I Boehringer Ingelheim Investigational Site
🇫🇷Sautron, France
1218.62.3302G Boehringer Ingelheim Investigational Site
🇫🇷VUE, France
1218.62.91001 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.62.91003 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, Andra Pradesh, India
1218.62.91004 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.62.91005 Boehringer Ingelheim Investigational Site
🇮🇳Nagpru, India
1218.62.91002 Boehringer Ingelheim Investigational Site
🇮🇳Trivandrum, India
1218.62.39010 Boehringer Ingelheim Investigational Site
🇮🇹Ancona, Italy
1218.62.31003 Boehringer Ingelheim Investigational Site
🇳🇱Woerden, Netherlands