Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00309608
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients receive tablets identical to those containing Linagliptin low, medium and high dose Linagliptin low dose Linagliptin Patients receive Linagliptin low dose tablets once daily Linagliptin medium dose Linagliptin Patients receive Linagliptin medium dose tablets once daily Linagliptin high dose Linagliptin Patients receive Linagliptin high dose tablets once daily Glimepiride Glimepiride Patients receive Glimepiride tablets once daily
- 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 HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
- Secondary Outcome Measures
Name Time Method Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 Baseline and week 12 This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Percentage of Patients With HbA1c<=7.0% at Week 12 week 12 Descriptive calculation of Patients with HbA1c \<= 7.0% at Week 12.
Trial Locations
- Locations (48)
1218.6.3305A Euraxi Pharma
🇫🇷Joue les Tours, France
1218.6.42105 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1218.6.42104 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1218.6.46003 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1218.6.49009 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1218.6.49015 Boehringer Ingelheim Investigational Site
🇩🇪Sulzbach-Rosenberg, Germany
1218.6.49002 Boehringer Ingelheim Investigational Site
🇩🇪Saarbrücken, Germany
1218.6.49017 Boehringer Ingelheim Investigational Site
🇩🇪Offenbach a. M., Germany
1218.6.49007 Boehringer Ingelheim Investigational Site
🇩🇪Aschaffenburg, Germany
1218.6.42103 Boehringer Ingelheim Investigational Site
🇸🇰Banska Bystrica, Slovakia
1218.6.44017 Boehringer Ingelheim Investigational Site
🇬🇧Liverpool, United Kingdom
1218.6.49014 Boehringer Ingelheim Investigational Site
🇩🇪Heidelberg, Germany
1218.6.44009 Boehringer Ingelheim Investigational Site
🇬🇧Newcastle upon Tyne, United Kingdom
1218.6.49011 Boehringer Ingelheim Investigational Site
🇩🇪Sinsheim, Germany
1218.6.44016 Boehringer Ingelheim Investigational Site
🇬🇧Chorley, United Kingdom
1218.6.3303A Boehringer Ingelheim Investigational Site
🇫🇷Joué Les Tours, France
1218.6.49008 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
1218.6.44015 Boehringer Ingelheim Investigational Site
🇬🇧Glasgow, United Kingdom
1218.6.3304A Boehringer Ingelheim Investigational Site
🇫🇷Joue les Tours, France
1218.6.49012 Boehringer Ingelheim Investigational Site
🇩🇪Immenstadt, Germany
1218.6.49010 Boehringer Ingelheim Investigational Site
🇩🇪St. Ingbert/Oberwürzbach, Germany
1218.6.49013 Boehringer Ingelheim Investigational Site
🇩🇪Bosenheim, Germany
1218.6.46002 Boehringer Ingelheim Investigational Site
🇸🇪Uddevalla, Sweden
1218.6.44004 Boehringer Ingelheim Investigational Site
🇬🇧Baillieston, Glasgow, United Kingdom
1218.6.3302A Boehringer Ingelheim Investigational Site
🇫🇷Joué les Tours, France
1218.6.3301A Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 13, France
1218.6.44018 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom
1218.6.44006 Boehringer Ingelheim Investigational Site
🇬🇧Exeter, United Kingdom
1218.6.49001 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1218.6.49005 Boehringer Ingelheim Investigational Site
🇩🇪Neuwied, Germany
1218.6.42101 Boehringer Ingelheim Investigational Site
🇸🇰Nove Mesto nad Vahom, Slovakia
1218.6.46001 Boehringer Ingelheim Investigational Site
🇸🇪Malmö, Sweden
1218.6.44007 Boehringer Ingelheim Investigational Site
🇬🇧Dundee, United Kingdom
1218.6.44008 Boehringer Ingelheim Investigational Site
🇬🇧Guildford, United Kingdom
1218.6.44019 Boehringer Ingelheim Investigational Site
🇬🇧Reading, United Kingdom
1218.6.44005 Boehringer Ingelheim Investigational Site
🇬🇧Gillingham, United Kingdom
1218.6.44001 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1218.6.49016 Boehringer Ingelheim Investigational Site
🇩🇪Wangen, Germany
1218.6.49003 Boehringer Ingelheim Investigational Site
🇩🇪Würzburg, Germany
1218.6.46004 Boehringer Ingelheim Investigational Site
🇸🇪Uppsala, Sweden
1218.6.44012 Boehringer Ingelheim Investigational Site
🇬🇧Ashford, United Kingdom
1218.6.44013 Boehringer Ingelheim Investigational Site
🇬🇧Camberley, United Kingdom
1218.6.44002 Boehringer Ingelheim Investigational Site
🇬🇧Bath, United Kingdom
1218.6.44003 Boehringer Ingelheim Investigational Site
🇬🇧Birmingham, United Kingdom
1218.6.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.6.38005 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.6.38002 Boehringer Ingelheim Investigational Site
🇺🇦Dnyepropetrovsk, Ukraine
1218.6.38001 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine