Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 156
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

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 who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Arms:
arm 1: Metformin 500-1500 mg (open-label, as needed for rescue in LT) arm 2: Metformin 500-1500 mg (open-label, as needed for rescue in LT)

Interventions: intervention 1: Saxagliptin intervention 2: Placebo intervention 3: Metformin (blinded) intervention 4: Metformin (open-label)
Intervention descriptions: intervention 1: Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT) intervention 2: Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST) intervention 3: Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12) intervention 4: Tablets, Oral, 500-1500 mg, as needed (starting in LT)

Protocol document: