drugset / Trial / NCT01214239

Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control

NCT01214239 ↗

Phase 3 Completed 300 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 in monotherapy in patients with type 2 diabetes and insufficient glycaemic control.

Timeline

Start
2010-10
Primary completion
2012-05
Completion
—

Outcome

Met primary endpoint

registry Placebo vs Linagliptin 5mg; p <0.0001; Adjusted mean difference -0.50 (95% CI -0.71 to -0.28); ANCOVA NCT01214239 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Linagliptin Unknown 5 mg Oral