Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1615
Healthy volunteers: no

Brief summary:
A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

Interventions: intervention 1: Sitagliptin phosphate intervention 2: Pioglitazone hydrochloride intervention 3: Matching placebo to sitagliptin intervention 4: Matching placebo to pioglitazone intervention 5: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks. intervention 2: Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4. intervention 3: Matching placebo to sitagliptin orally once daily for 54 weeks. intervention 4: Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks. intervention 5: Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.

Protocol document: