NCT01472185

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 465 (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, 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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ranolazine	Ranolazine tablets administered orally twice daily.
DRUG	Placebo	Placebo to match ranolazine administered orally twice daily.
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: 2011-11-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-11-16
• Last updated: 2014-10-24
• Results posted: 2014-10-15

Locations

159 sites across 10 countries: United States, Czechia, Hungary, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine