Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1035
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently 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 added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Arms:
arm 1: Metformin 500-2000 mg (as needed for rescue) arm 2: Metformin 500-2000 mg (as needed for rescue) arm 3: Metformin 500-2000 mg (as needed for rescue) arm 4: Metformin 500-2000 mg (as needed for rescue) arm 5: Saxagliptin 10 mg

Metformin 500-2000 mg (as needed for rescue)

Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Placebo matching Saxagliptin intervention 5: Metformin intervention 6: Placebo matching Metformin intervention 7: Saxagliptin intervention 8: Metformin
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\]) intervention 2: Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT) intervention 3: Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) intervention 4: Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT) intervention 5: Tablets, Oral, 500 mg, daily (42 months LT) intervention 6: Tablets, Oral, 0 mg, daily (42 months LT) intervention 7: Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label intervention 8: Tablets, Oral, 500-2000 mg (as needed for rescue)

Protocol document: