Conditions: Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 365
Healthy volunteers: no

Brief summary:
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

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 metformin (rescue medication) added onto their blinded study medication

Arms:
arm 1: PLUS open-label metformin (as needed as rescue medication) arm 2: PLUS open-label metformin (as needed as rescue medication) arm 3: PLUS open-label metformin (as needed as rescue medication) arm 4: PLUS open-label metformin (as needed as rescue medication) arm 5: PLUS open-label metformin (as needed as rescue medication)

Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Placebo intervention 6: metformin
Intervention descriptions: intervention 1: Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT) intervention 5: Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT) intervention 6: Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Protocol document: