Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
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
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Ranolazine; p < 0.0001; difference in least squares mean (LSM) -0.56 (95% CI -0.76 to -0.36) NCT01472185 ↗
paper there was a greater decline in HbA1c at week 24 from baseline (primary end point) in subjects taking ranolazine PMID 26049552 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranolazine | Small molecule | 1000 mg | Oral |