Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 166
Healthy volunteers: no

Brief summary:
This two-phase study was to examine if 16 weeks of treatment with sitagliptin in combination with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively. Following a single-blind placebo run-in period, participants were to be randomized to one of three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54), participants were to receive either sitagliptin plus atorvastatin or glimepiride plus atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than sitagliptin alone.

Detailed description:

Arms:
arm 1: In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. arm 2: In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks. arm 3: In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.

Interventions: intervention 1: Sitagliptin intervention 2: Atorvastatin intervention 3: Placebo to sitagliptin intervention 4: Placebo to atorvastatin intervention 5: Metformin (open-label) intervention 6: Glimepiride (open-label) intervention 7: Glimepiride (double-blind) intervention 8: Placebo to glimepiride
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet orally daily intervention 2: Atorvastatin 80 mg tablet orally daily intervention 3: Placebo to sitagliptin tablet orally daily intervention 4: Placebo to atorvastatin tablet orally daily. intervention 5: Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study. intervention 6: Phase A: Glimepiride 1 or 2 mg tablet once daily with breakfast or the first main meal of the day (titrated up to 6 mg/day) for 16 weeks as rescue therapy for randomized participants not meeting specific glycemic goals. intervention 7: Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A. intervention 8: Phase B: placebo to glimepiride tablet orally daily.

Protocol document: