At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,549 enrolled
Drug / intervention
BI 10773 +3 moredrug
Likely dose
Glimepiride 4 mgfrom 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 Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
In Brief
A Phase 3 clinical trial evaluating BI 10773, Glimepiride, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 1,549 participants across 182 sites in 23 countries.
Detailed Summary
This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Austria, Canada, Colombia, Czechia, Finland, Hong Kong, India, Italy, Malaysia, Mexico, Netherlands, Norway, Philippines, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartAug 2010
Primary CompletionAug 2013
Study CompletionAug 2015
TodayJul 2026
First PostedJul 22, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2013
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.9 years ago
Interventions
BI 10773drug
Medium dose once daily
Glimepiridedrug
1-4 mg once daily
Placebodrug
Placebo matching BI 10773
Placebodrug
Placebo matching Glimepiride