At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 389 enrolled
Drug / intervention
placebo + pioglitazone (30 mg) +1 moredrug
Likely dose
placebo + pioglitazone (30 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control.
In Brief
A Phase 3 clinical trial evaluating placebo + pioglitazone (30 mg) and Linagliptin + pioglitazone (30 mg) for Diabetes Mellitus, Type 2. Completed, enrolled 389 participants across 43 sites in 7 countries.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustria, Greece, Hungary, Japan, Portugal, Romania, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMar 2008
Primary CompletionJun 2009
TodayJul 2026
First PostedMar 21, 2008
Enrollment StartMar 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago
Interventions
placebo + pioglitazone (30 mg)drug
placebo + overcapsulated 30 mg tablet, once daily
Linagliptin + pioglitazone (30 mg)drug
5 mg tablet + overcapsulated 30 mg tablet, once daily