Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 465
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen. arm 2: Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.

Interventions: intervention 1: Ranolazine intervention 2: Placebo intervention 3: Diet intervention 4: Exercise
Intervention descriptions: intervention 1: Ranolazine tablets administered orally twice daily. intervention 2: Placebo to match ranolazine administered orally twice daily. intervention 3: Participants are instructed to continue the diet regimen prescribed by their physician. intervention 4: Participants are instructed to continue the exercise regimen prescribed by their physician.

Protocol document: