Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 461
Healthy volunteers: no

Brief summary:
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Detailed description:

Arms:
arm 1: Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily) arm 2: Sitagliptin 100 mg and matching placebo 0 mg (once daily)

Interventions: intervention 1: Saxagliptin intervention 2: Dapagliflozin intervention 3: Sitagliptin intervention 4: Placebo matching with Saxagliptin intervention 5: Placebo matching with Dapagliflozin intervention 6: Placebo matching with Sitagliptin
Intervention descriptions: intervention 1: administered orally once daily intervention 2: administered orally once daily intervention 3: administered orally once daily intervention 4: administered orally once daily intervention 5: administered orally once daily intervention 6: administered orally once daily

Protocol document: