At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 741 enrolled
Drug / intervention
BI 10773 +5 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 III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
In Brief
A Phase 3 clinical trial evaluating BI 10773 and Placebo for Diabetes Mellitus, Type 2 and Renal Insufficiency. Completed, enrolled 741 participants across 127 sites in 15 countries.
Detailed Summary
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Renal Insufficiency
CountriesCanada, France, Hong Kong, India, Malaysia, Netherlands, Philippines, Poland, Portugal, Russia, Slovakia, South Africa, Spain, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedJul 2010
Primary CompletionJul 2012
TodayJul 2026
First PostedJul 16, 2010
Enrollment StartJul 1, 2010
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.0 years ago
Interventions
BI 10773drug
BI 10773 tablets once daily
Placebodrug
Placebo tablets identical to BI 10773 low dose
Placebodrug
Placebo tablets identical to BI 10773 high dose
BI 10773drug
BI 10773 tablets once daily
Placebodrug
Placebo tablets identical to BI 10773 low dose
Placebodrug
Placebo tablets identical to BI 10773 high dose