Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 442
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening).

Treatment Period: Participants will receive ranolazine 500 mg + metformin 500 mg + placebo to match metformin twice daily on Days 1 through 7, followed by ranolazine 1000 mg + metformin 500 mg + placebo to match metformin twice daily from Day 8 through Week 24.

Participants are required to maintain their diet and exercise regimen. arm 2: Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening).

Treatment Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily through Week 24.

Participants are required to maintain their diet and exercise regimen.

Interventions: intervention 1: Ranolazine intervention 2: Placebo to match ranolazine intervention 3: Metformin intervention 4: Placebo to match metformin intervention 5: Diet intervention 6: Exercise
Intervention descriptions: intervention 1: Ranolazine tablet(s) administered orally intervention 2: Placebo to match ranolazine for the duration of the study intervention 3: Metformin tablet(s) administered orally once daily intervention 4: Placebo to match metformin for the duration of the study intervention 5: Participants are instructed to continue the diet regimen prescribed by their physician. intervention 6: Participants are instructed to continue the exercise regimen prescribed by their physician.

Protocol document: