Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 219
Healthy volunteers: no

Brief summary:
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Detailed description:

Arms:
arm 1: (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) arm 2: (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)

Interventions: intervention 1: Saxagliptin intervention 2: Metformin XR intervention 3: Placebo matching Metformin XR intervention 4: Metformin XR intervention 5: Placebo matching Saxagliptin
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, once daily, 4 weeks intervention 2: Tablets, Oral, 1500 mg, once daily, 4 weeks intervention 3: Tablets, Oral, 0 mg, once daily, 4 weeks intervention 4: Tablets, Oral, 500 mg, once daily, 4 weeks intervention 5: Tablets, Oral, 0 mg, once daily, 4 weeks

Protocol document: