Conditions: Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1306
Healthy volunteers: no

Brief summary:
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication

Arms:
arm 1: PLUS open-label pioglitazone (as needed as rescue medication) arm 2: PLUS open-label pioglitazone (as needed as rescue medication) arm 3: PLUS open-label pioglitazone (as needed as rescue medication) arm 4: PLUS open-label pioglitazone (as needed as rescue medication)

Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Metformin intervention 4: Placebo intervention 5: pioglitazone
Intervention descriptions: intervention 1: Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) intervention 5: Tablets, Oral, 15-45 mg, as needed (12 months LT)

Protocol document: