Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
Summary
This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. The study assessed the metabolic effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c), and lowering glucose while fasting, and following a meal (postprandial). Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were stratified by HbA1c ≤ 7.5% or \> 7.5%. Enrollment was to include no more than two-thirds of participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results remained blinded during the study; for safety purposes, the investigator was to be alerted of severe hyperglycemia or hypoglycemia. Participants were instructed to maintain logs of their physical activity/exercise (Subject Activity Assessment) and study drug dosing (Dosing Log).
Timeline
- Start
- 2010-06
- Primary completion
- 2010-11
- Completion
- 2010-11
Outcome
Mixed primary results
registry LEAST_SQUARES_MEAN Ranolazine: -0.61 (Standard Error 0.142) percent of HbA1c in blood NCT01163721 ↗
registry Ranolazine vs Placebo; p = 0.010; difference in least squares mean (LSM) -0.53 (95% CI -0.93 to -0.13) NCT01163721 ↗
registry Ranolazine vs Placebo; p = 0.234; difference in LSM -15.4 (95% CI -41.0 to 10.2) NCT01163721 ↗
registry Ranolazine vs Placebo; p = 0.794; difference in least squares mean (LSM) -2.5 (95% CI -21.1 to 16.2) NCT01163721 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranolazine | Small molecule | 1000 mg | Oral |