drugset / Trial / NCT01215097
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
RandomizedParallel-groupDouble-blindTreatment
Summary
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.
Timeline
- Start
- 2010-10
- Primary completion
- 2012-04
- Completion
- 2012-04
Outcome
Met primary endpoint
registry Placebo vs Linagliptin 5mg; p <0.0001; Adjusted mean difference -0.52 (95% CI -0.70 to -0.34); ANCOVA NCT01215097 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linagliptin | Unknown | 5 mg | Oral |