Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
Timeline
- Start
- 2006-05
- Primary completion
- 2007-08
- Completion
- —
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Linagliptin (BI 1356) 2.5 mg; p = 0.0032; Mean Difference (Final Values) -0.42 (95% CI -0.69 to -0.14); ANCOVA NCT00328172 ↗
registry analysis (superiority or other test); Placebo vs Linagliptin (BI 1356) 5.0 mg; p = 0.0012; Mean Difference (Final Values) -0.46 (95% CI -0.74 to -0.18); ANCOVA NCT00328172 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linagliptin | Unknown | 0.5 mg | Oral |
| Subject | Linagliptin | Unknown | 2.5 mg | Oral |
| Subject | Linagliptin | Unknown | 5 mg | Oral |
| Comparator | Metformin | Small molecule | — | — |