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
Abstract
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.
Conditions: Diabetes Mellitus, Type 2, Renal Insufficiency.
Primary outcome: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment; HbA1c Change From Baseline in Patients With Mild Renal Impairment; HbA1c Change From Baseline in Patients With Moderate Renal Impairment.
Enrollment: 741 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 741 participants or records.
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