Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 565
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD 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 metformin (defined as rescue medication) added onto their blinded study medication

Arms:
arm 1: Saxagliptin PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication) arm 2: Saxagliptin PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication) arm 3: Placebo PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication)

Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Placebo intervention 4: pioglitazone intervention 5: rosiglitazone intervention 6: metformin
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT) intervention 2: Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT) intervention 3: Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT) intervention 4: Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) intervention 5: Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) intervention 6: Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Protocol document: