A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control
Abstract
The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed
Conditions: Diabetes Mellitus, Type 2.
Primary outcome: Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment.
Enrollment: 408 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: 408 participants or records.
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