Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 2 safety and efficacy study with PF-04991532 Type 2 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 301
Healthy volunteers: no

Brief summary:
B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Detailed description:

Arms:
arm 1: Placebo for PF-04991532 and sitagliptin arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: Placebo intervention 2: 25 mg PF-04991532 intervention 3: 75 mg PF-04991532 intervention 4: 150 mg PF-04991532 intervention 5: 300 mg PF-04991532 intervention 6: Sitagliptin 100 mg
Intervention descriptions: intervention 1: Tablets (n=4), 0 mg twice daily for 84 days intervention 2: Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days intervention 3: Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days intervention 4: Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days intervention 5: Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days intervention 6: Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.

Protocol document: