Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00915772
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 567
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Linagliptin + metformin bid Linagliptin + metformin Linagliptin low dose + metformin 500 mg, bid Linagliptin+ metformin bid Linagliptin+metformin Linagliptin low dose + metformin 1000 mg bid Metformin bid Metformin Metformin 1000 mg bid
- Primary Outcome Measures
Name Time Method Frequency of Patients With Adverse Events (AEs) 54 weeks This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) 54 weeks Baseline is defined as Visit 1 of 1218.52.
Change From Baseline at Week 54 in Pulse Rate 54 weeks Baseline is defined as Visit 1 of 1218.52.
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology 54 weeks Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry 54 weeks ULN means upper limit of normal
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE Baseline and drug stop (up to 54 weeks) + 7 days Frequency of patients with adverse events by treatment, primary system organ class and preferred term
- Secondary Outcome Measures
Name Time Method Change in HbA1c From Baseline Over Time 78 weeks HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).
Number of Patients With HbA1c <7.0% After 54 Weeks 54 weeks Number of Patients With HbA1c <6.5% Over Time 54 weeks Number of Patients With HbA1c of at Least <0.5% Over Time 54 weeks Change in FPG From Baseline Over Time 54 weeks Baseline is defined as visit 1 of 1218.52.
Number of Patients With Rescue Therapy 54 weeks
Trial Locations
- Locations (112)
1218.52.11003 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1218.52.11002 Boehringer Ingelheim Investigational Site
🇨🇦Red Deer, Alberta, Canada
1218.52.38502 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Karlovac, Croatia
1218.52.11006 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1218.52.38503 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Krapinske Toplice, Croatia
1218.52.38504 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Osijek, Croatia
1218.52.38501 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Sisak, Croatia
1218.52.37202 Boehringer Ingelheim Investigational Site
🇪🇪Pärnu, Estonia
1218.52.37201 Boehringer Ingelheim Investigational Site
🇪🇪Tallin, Estonia
1218.52.91009 Boehringer Ingelheim Investigational Site
🇮🇳Aurangabad, India
1218.52.91001 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.52.91012 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.52.91011 Boehringer Ingelheim Investigational Site
🇮🇳Bhopal, India
1218.52.91003 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1218.52.91020 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1218.52.91007 Boehringer Ingelheim Investigational Site
🇮🇳Karnataka, India
1218.52.91013 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
1218.52.91015 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1218.52.91014 Boehringer Ingelheim Investigational Site
🇮🇳Nagpru, India
1218.52.91016 Boehringer Ingelheim Investigational Site
🇮🇳P.O.Trivandrum, India
1218.52.91010 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1218.52.37001 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
1218.52.37003 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
1218.52.52006 Boehringer Ingelheim Investigational Site
🇲🇽Aguascalientes, Mexico
1218.52.52002 Boehringer Ingelheim Investigational Site
🇲🇽Cuernavaca, Mexico
1218.52.52004 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1218.52.52009 Boehringer Ingelheim Investigational Site
🇲🇽Veracruz, Mexico
1218.52.31004 Boehringer Ingelheim Investigational Site
🇳🇱's Hertogenbosch, Netherlands
1218.52.31001 Boehringer Ingelheim Investigational Site
🇳🇱Almere, Netherlands
1218.52.31002 Boehringer Ingelheim Investigational Site
🇳🇱Beek en Donk, Netherlands
1218.52.31010 Boehringer Ingelheim Investigational Site
🇳🇱Breda, Netherlands
1218.52.31013 Boehringer Ingelheim Investigational Site
🇳🇱Groningen, Netherlands
1218.52.40001 Boehringer Ingelheim Investigational Site
🇷🇴Alba Iulia, Romania
1218.52.31014 Boehringer Ingelheim Investigational Site
🇳🇱Velp, Netherlands
1218.52.40005 Boehringer Ingelheim Investigational Site
🇷🇴Galati, Romania
1218.52.40003 Boehringer Ingelheim Investigational Site
🇷🇴Oradea, Romania
1218.52.40002 Boehringer Ingelheim Investigational Site
🇷🇴Ploiesti, Romania
1218.52.70001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.52.70004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.52.70002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.52.70005 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.52.70007 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.52.2161B Boehringer Ingelheim Investigational Site
🇹🇳Tunis, Tunisia
1218.52.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.52.38001 Boehringer Ingelheim Investigational Site
🇺🇦Lviv, Ukraine
1218.52.38002 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1218.52.38004 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1218.52.38006 Boehringer Ingelheim Investigational Site
🇺🇦Vinnitsa, Ukraine
1218.52.3303D Boehringer Ingelheim Investigational Site
🇫🇷Aire sur l'Aadour, France
1218.52.91006 Boehringer Ingelheim Investigational Site
🇮🇳West Bengal, India
1218.52.11004 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1218.52.3304F Boehringer Ingelheim Investigational Site
🇫🇷Bousse, France
1218.52.3308B Boehringer Ingelheim Investigational Site
🇫🇷Bischheim, France
1218.52.3306A Boehringer Ingelheim Investigational Site
🇫🇷Ortez, France
1218.52.91018 Boehringer Ingelheim Investigational Site
🇮🇳Hyderadad, India
1218.52.11005 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1218.52.11007 Boehringer Ingelheim Investigational Site
🇨🇦Oakville, Ontario, Canada
1218.52.11008 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1218.52.49007 Boehringer Ingelheim Investigational Site
🇩🇪Schauenburg, Germany
1218.52.37203 Boehringer Ingelheim Investigational Site
🇪🇪Tallin, Estonia
1218.52.3305B Boehringer Ingelheim Investigational Site
🇫🇷Guerigny, France
1218.52.3305A Boehringer Ingelheim Investigational Site
🇫🇷Bourges, France
1218.52.3308C Boehringer Ingelheim Investigational Site
🇫🇷Gambsheim, France
1218.52.3304A Boehringer Ingelheim Investigational Site
🇫🇷Jarny, France
1218.52.3305G Boehringer Ingelheim Investigational Site
🇫🇷Lury, France
1218.52.3308D Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1218.52.91004 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.52.46001 Boehringer Ingelheim Investigational Site
🇸🇪Uppsala, Sweden
1218.52.49006 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
1218.52.46003 Boehringer Ingelheim Investigational Site
🇸🇪Malmo, Sweden
1218.52.2162A Boehringer Ingelheim Investigational Site
🇹🇳Bab Saâdoun Tunis, Tunisia
1218.52.2162B Boehringer Ingelheim Investigational Site
🇹🇳Bab Sâadoun Tunis, Tunisia
1218.52.9992 Boehringer Ingelheim Investigational Site
🇹🇳Bab Sâadoun Tunis, Tunisia
1218.52.2163B Boehringer Ingelheim Investigational Site
🇹🇳Tunis, Tunisia
1218.52.9991 Boehringer Ingelheim Investigational Site
🇹🇳Tunis, Tunisia
1218.52.9999 Boehringer Ingelheim Investigational Site
🇫🇷La Riche, France
1218.52.3307E Boehringer Ingelheim Investigational Site
🇫🇷La Seyne sur Mer, France
1218.52.3303A Boehringer Ingelheim Investigational Site
🇫🇷Mont de Marsan, France
1218.52.3308F Boehringer Ingelheim Investigational Site
🇫🇷Mundolsheim, France
1218.52.3305E Boehringer Ingelheim Investigational Site
🇫🇷Nevers, France
1218.52.3306C Boehringer Ingelheim Investigational Site
🇫🇷Orthez, France
1218.52.3302E Boehringer Ingelheim Investigational Site
🇫🇷Savonnières, France
1218.52.3308A Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1218.52.3308E Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1218.52.3302A Boehringer Ingelheim Investigational Site
🇫🇷Tours, France
1218.52.11010 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1218.52.38505 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡·Rijeka, Croatia
1218.52.3301A Boehringer Ingelheim Investigational Site
🇫🇷Grenoble cédex, France
1218.52.3302D Boehringer Ingelheim Investigational Site
🇫🇷La Riche, France
1218.52.3307A Boehringer Ingelheim Investigational Site
🇫🇷La Seyne sur Mer, France
1218.52.3303B Boehringer Ingelheim Investigational Site
🇫🇷St Martin d'Oney, France
1218.52.49003 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1218.52.3307D Boehringer Ingelheim Investigational Site
🇫🇷Toulon, France
1218.52.49002 Boehringer Ingelheim Investigational Site
🇩🇪Bad Dürrheim-Sunthausen, Germany
1218.52.91002 Boehringer Ingelheim Investigational Site
🇮🇳Karnataka, India
1218.52.91008 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
1218.52.91019 Boehringer Ingelheim Investigational Site
🇮🇳Madurai, India
1218.52.37004 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
1218.52.52007 Boehringer Ingelheim Investigational Site
🇲🇽Mexico, Mexico
1218.52.52010 Boehringer Ingelheim Investigational Site
🇲🇽Tijuana, Mexico
1218.52.52008 Boehringer Ingelheim Investigational Site
🇲🇽Mexico, Mexico
1218.52.31005 Boehringer Ingelheim Investigational Site
🇳🇱's Hertogenbosch, Netherlands
1218.52.31015 Boehringer Ingelheim Investigational Site
🇳🇱Zoetermeer, Netherlands
1218.52.70003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.52.40004 Boehringer Ingelheim Investigational Site
🇷🇴Satu Mare, Romania
1218.52.46002 Boehringer Ingelheim Investigational Site
🇸🇪Goteborg, Sweden
1218.52.70006 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.52.46005 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1218.52.2161A Boehringer Ingelheim Investigational Site
🇹🇳Tunis, Tunisia
1218.52.9993 Boehringer Ingelheim Investigational Site
🇹🇳Tunis, Tunisia
1218.52.2163A Boehringer Ingelheim Investigational Site
🇹🇳Tunis, Tunisia
1218.52.38005 Boehringer Ingelheim Investigational Site
🇺🇦Lvov, Ukraine