drugset / Trial / NCT01555164
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2012-06
- Primary completion
- 2013-09
- Completion
- 2013-10
Outcome
Missed primary endpoint
registry p = 0.306; difference in least squares mean (LSM) -0.11 (95% CI -0.31 to 0.10) NCT01555164 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranolazine | Small molecule | 1000 mg | Oral |
| Background | Metformin | Small molecule | 500 mg | Oral |
| Background | Metformin | Small molecule | 1000 mg | Oral |