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Data Demonstrated Saxagliptin Added to Metformin Improved Glycemic,Control in Subjects with Type 2 Diabetes Compared to Metformin,Alone

Additional Findings Reported Safety & Tolerability Profile in Subjects with Type 2 Diabetes and Healthy Subjects

CHICAGO, June 25 /PRNewswire-FirstCall/ -- Phase III data presented this week at the annual meeting of the American Diabetes Association demonstrated that saxagliptin, an inhibitor of dipeptidyl-peptidase-4 (DPP-4) in development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN), in combination with metformin, exhibited a statistically significant improvement in glycemic control in subjects with Type 2 diabetes compared to metformin alone through 24 weeks of treatment. This was the first time that Phase III data for saxagliptin have been presented in a scientific setting.


A group of 743 subjects (ages 18-77) with Type 2 diabetes whose hemoglobin A1C level was within the range of greater than or equal to 7 percent or less than or equal to 10 percent and on a stable metformin dose alone (1500 to 2550 mg/day) were randomized 1:1:1:1 to add-on saxagliptin 2.5 mg, 5 mg, 10 mg, or placebo once daily. The primary endpoint of the study was the change from baseline in hemoglobin A1C levels. After 24 weeks, the subjects receiving saxagliptin+metformin demonstrated statistically significant decreases in hemoglobin A1C levels compared to placebo+metformin: -0.73 percent, -0.83 percent, and -0.72 percent at the 2.5 mg, 5 mg and 10 mg doses, respectively (p-value at all dosage levels less than 0.0001 vs. placebo+metformin).

Saxagliptin+metformin also statistically significantly reduced fasting plasma glucose (secondary endpoint) as compared to placebo+metformin: -16 mg/dL, -23 mg/dL, and -22 mg/dL for saxagliptin 2.5 mg, 5 mg and 10 mg, respectively (p-value at all dosage levels less than 0.0001 vs. placebo+metformin). The percentage of subjects with hemoglobin A1C less than 7 percent at Week 24 (secondary endpoint) was 17 percent for placebo+metformin and
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