At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 660 enrolled
Drug / intervention
BI 10773 +3 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 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients
In Brief
A Phase 2 clinical trial evaluating BI 10773, Metformin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 660 participants across 137 sites in 21 countries.
Detailed Summary
The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustria, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Norway, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedApr 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedApr 15, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.2 years ago
Interventions
BI 10773drug
BI 10773 high dose once daily
Metformindrug
open label comparator
BI 10773drug
BI 10773 low dose once daily
Sitagliptindrug
open label comparator