At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Metformin in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Ranolazine, Placebo to match ranolazine, and 4 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 442 participants across 146 sites in 11 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable 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
Metformin tablet(s) administered orally once daily
Placebo to match metformin for the duration of the study
Participants are instructed to continue the diet regimen prescribed by their physician.
Participants are instructed to continue the exercise regimen prescribed by their physician.