drugset / Trial / NCT01494987

Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

NCT01494987 ↗

Phase 3 Completed 431 enrolled Gilead Sciences
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when added to glimepiride on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.

Timeline

Start
2012-01
Primary completion
2013-08
Completion
2013-08

Outcome

Met primary endpoint

registry Placebo+Glimepiride vs Ranolazine+Glimepiride; p <0.001; difference in least squares mean (LSM) -0.51 (95% CI -0.71 to -0.32) NCT01494987 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranolazine Small molecule 1000 mg Oral
Background Glimepiride Small molecule 4 mg Oral