Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 299
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

Detailed description:

Arms:
arm 1: Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. arm 2: Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. arm 3: Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.

Interventions: intervention 1: Sitagliptin/Simvastatin FDC intervention 2: Sitagliptin intervention 3: Simvastatin intervention 4: Placebo to sitagliptin intervention 5: Placebo to simvastatin intervention 6: Placebo to Sitagliptin/Simvastatin FDC intervention 7: Metformin intervention 8: Glimepiride
Intervention descriptions: intervention 1: Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet intervention 2: Sitagliptin 100 mg tablet intervention 3: Simvastatin 40 mg tablet intervention 4: Matching placebo to sitagliptin 100 mg tablet intervention 5: Matching placebo to simvastatin 40 mg tablet intervention 6: Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet intervention 7: Participants will continue on their stable, pre-screening metformin daily dose of \>= 1500 mg for at least 12 weeks prior to randomization and during the study intervention 8: Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.

Protocol document: