Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 455
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

Detailed description:

Arms:
arm 1: Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin arm 2: Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

Interventions: intervention 1: Saxagliptin, 5 mg + insulin intervention 2: Placebo + insulin
Intervention descriptions: intervention 1: Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue) intervention 2: Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin

Protocol document: