At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 495 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 II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy
In Brief
A Phase 2 clinical trial evaluating BI 10773, placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 495 participants across 116 sites in 16 countries.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Austria, Czechia, Estonia, Finland, France, Germany, Hungary, Latvia, Norway, Romania, Russia, Slovakia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionOct 2009
TodayJul 2026
First PostedSep 9, 2008
Enrollment StartAug 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.8 years ago
Interventions
BI 10773drug
placebodrug
sitagliptindrug