A Randomized, Double-Blind, Parallel-Group Trial to Assess the Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin in Patients With Type 2 Diabetes Mellitus
Abstract
The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.
Conditions: Type 2 Diabetes.
Primary outcome: Change in Baseline to End of Study in HbA1c.
Enrollment: 66 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: 66 participants or records.
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