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 Monotherapy in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Ranolazine, Placebo, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 465 participants across 159 sites in 10 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones \[TZDs\] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.
Study Details
Timeline
Interventions
Ranolazine tablets administered orally twice daily.
Placebo to match ranolazine administered orally twice 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.