At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 494 enrolled
Drug / intervention
BI 10773 placebo +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 Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control
In Brief
A Phase 2 clinical trial evaluating BI 10773 placebo, BI 10773 low dose, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 494 participants across 99 sites in 7 countries.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesDenmark, France, Ireland, Portugal, South Korea, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedNov 2009
Primary CompletionMay 2012
TodayJul 2026
First PostedNov 11, 2009
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.6 years ago
Interventions
BI 10773 placebodrug
BI 10773 placebo
BI 10773 low dosedrug
BI 10773 low dose
BI 10773 high dosedrug
BI 10773 high dose
BI 10773 placebodrug
BI 10773 placebo