At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,162 enrolled
Drug / intervention
Metformin +4 moredrug
Likely dose
Metformin 2250 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 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
In Brief
A Phase 3 clinical trial evaluating Metformin, BI 10773, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 1,162 participants across 87 sites.
Detailed Summary
The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedJun 2011
Primary CompletionApr 2013
TodayJul 2026
First PostedJun 7, 2011
Enrollment StartMay 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.1 years ago
Interventions
Metformindrug
Metformin tablets 500-2250 mg a day (twice or three times per day)
BI 10773drug
BI 10773 low dose tablet once daily
Placebo (low dose)drug
Placebo tablets once daily
BI 10773drug
BI 10773 high dose tablet once daily
Placebo (high dose)drug
Placebo tablets once daily