Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus T2DM Ranolazine Ranexa HbA1c
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Participants were randomized to receive ranolazine for 12 weeks. arm 2: Participants were randomized to receive placebo to match ranolazine for 12 weeks.

Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily intervention 2: Placebo to match ranolazine administered orally twice daily

Protocol document: