drugset / Trial / NCT01183013

30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

NCT01183013

Phase 3 Completed 936 enrolled Boehringer Ingelheim Eli Lilly and Company · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Timeline

Start
2010-08
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Linagliptin Small molecule 5 mg Oral
Comparator Pioglitazone Small molecule 30 mg Oral
Comparator Pioglitazone Small molecule 45 mg Oral