NCT01555164

A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ranolazine	Ranolazine tablet(s) administered orally
DRUG	Placebo to match ranolazine	Placebo to match ranolazine for the duration of the study
DRUG	Metformin	Metformin tablet(s) administered orally once daily
DRUG	Placebo to match metformin	Placebo to match metformin for the duration of the study
BEHAVIORAL	Diet	Participants are instructed to continue the diet regimen prescribed by their physician.
BEHAVIORAL	Exercise	Participants are instructed to continue the exercise regimen prescribed by their physician.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2012-03-15
• Last updated: 2014-09-23
• Results posted: 2014-09-23

Locations

146 sites across 11 countries: United States, Canada, Czechia, Hungary, India, Israel, Mexico, Poland, Russia, South Africa, Ukraine