Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 423
Healthy volunteers: no

Brief summary:
To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

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: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Saxagliptin intervention 6: Saxagliptin intervention 7: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, once daily, 12 weeks intervention 2: Tablets, Oral, 5 mg, once daily, 12 weeks intervention 3: Tablets, Oral, 10 mg, once daily, 12 weeks intervention 4: Tablets, Oral, 20 mg, once daily, 12 weeks intervention 5: Tablets, Oral, 40 mg, once daily, 12 weeks intervention 6: Tablets, Oral, 100 mg, once daily, 6 weeks intervention 7: Tablets, Oral, 0 mg, once daily, 6 and 12 weeks

Protocol document: