Japanese P III vs Voglibose and Placebo
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
Timeline
- Start
- 2008-04
- Primary completion
- 2010-01
- Completion
- —
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Linagliptin 5mg; p <0.0001; Least Squares Mean Difference -0.87 (95% CI -1.04 to -0.7); ANCOVA NCT00654381 ↗
registry analysis (superiority or other test); Placebo vs Linagliptin 10 mg; p <0.0001; Least Squares Mean Difference -0.88 (95% CI -1.05 to -0.71); ANCOVA NCT00654381 ↗
registry analysis (superiority or other test); Linagliptin 5mg vs Voglibose; p = 0.0003; Least Squares Mean Difference -0.32 (95% CI -0.49 to -0.15); ANCOVA NCT00654381 ↗
registry analysis (superiority or other test); Linagliptin 10 mg vs Voglibose; p <0.0001; Least Squares Mean Difference -0.39 (95% CI -0.56 to -0.21); ANCOVA NCT00654381 ↗
Publications
- Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
- Horie Y, Hayashi N, Dugi K, Takeuchi M. Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo. Trials. 2009 Sep 5;10:82. doi: 10.1186/1745-6215-10-82.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linagliptin | Unknown | 5 mg | Oral |
| Subject | Linagliptin | Unknown | 10 mg | Oral |
| Comparator | Voglibose | Small molecule | 0.2 mg | Oral |