At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)
In Brief
A Phase 2 clinical trial evaluating Placebo (low dose), Placebo (mid dose), and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 547 participants across 32 sites.
Detailed Summary
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.
Study Details
Timeline
Interventions
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets low dose once a day
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets mid-low dose once a day
Placebo tablets once a day