A 16-week, phase 2B, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of twice daily PF-06882961 administration in adults with type 2 diabetes mellitus inadequately controlled on metformin or diet and exercise
Abstract
This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.
Conditions: Diabetes Mellitus, Type 2.
Primary outcome: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16.
Enrollment: 412 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: 412 participants or records.
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