A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.
Overview
- Phase
- Phase 2
- Intervention
- Linagliptin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 333
- Locations
- 48
- Primary Endpoint
- HbA1c Change From Baseline at Week 12
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linagliptin low dose
Patients receive Linagliptin low dose tablets once daily
Intervention: Linagliptin
Linagliptin medium dose
Patients receive Linagliptin medium dose tablets once daily
Intervention: Linagliptin
Linagliptin high dose
Patients receive Linagliptin high dose tablets once daily
Intervention: Linagliptin
Placebo
Patients receive tablets identical to those containing Linagliptin low, medium and high dose
Intervention: Placebo
Glimepiride
Patients receive Glimepiride tablets once daily
Intervention: Glimepiride
Outcomes
Primary Outcomes
HbA1c Change From Baseline at Week 12
Time Frame: 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 Outcomes
- Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12(Baseline and week 12)
- Percentage of Patients With HbA1c<=7.0% at Week 12(week 12)