At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 408 enrolled
Drug / intervention
BI 10773 +2 moredrug
Likely dose
Not stated in 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 IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control
In Brief
A Phase 2 clinical trial evaluating BI 10773, placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 408 participants across 74 sites in 13 countries.
Detailed Summary
The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Croatia, Estonia, Germany, Italy, Lithuania, Romania, Russia, Slovakia, South Korea, Sweden, Taiwan, Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedNov 2008
Primary CompletionOct 2009
TodayJul 2026
First PostedNov 11, 2008
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.6 years ago
Interventions
BI 10773drug
placebodrug
metformindrug