CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,560 enrolled
Drug / intervention
Placebo identical to BI 1356 5mg +3 moredrug
Likely dose
Placebo identical to BI 1356 5mgfrom 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.

Search/NCT00622284
NCT00622284Phase 3Completed
CompareCT.gov

A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Boehringer Ingelheim·interventional·Posted Feb 25, 2008·Updated Jan 29, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo identical to BI 1356 5mg, Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 1,560 participants across 221 sites in 16 countries.

Detailed Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBulgaria, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Netherlands, Norway, Poland, South Africa, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2008
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

Placebo identical to BI 1356 5mgdrug

Placebo tablet once daily

Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mgdrug

Placebo tablets once daily

BI 1356drug

5mg, once daily in the morning for 104 weeks

Glimepiridedrug

1mg or 2mg or 3mg or 4mg in the morning for 104 weeks