At a glance
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Ranolazine, Placebo, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 431 participants across 140 sites in 12 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when added to glimepiride on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.
Study Details
Timeline
Interventions
Ranolazine tablet(s) administered orally
Placebo to match ranolazine for the duration of the study
Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.
Participants are instructed to continue the diet regimen prescribed by their physician.
Participants are instructed to continue the exercise regimen prescribed by their physician.