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

NCT01215097 ↗

Phase 3 Completed 306 enrolled Boehringer Ingelheim Eli Lilly and Company · collab
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

EvaluationDrugModalityDoseRoute
Subject Linagliptin Unknown 5 mg Oral