drugset / Trial / NCT01472185

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

NCT01472185

Phase 3 Completed 465 enrolled Gilead Sciences
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2011-11
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranolazine Small molecule 1000 mg Oral