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First Phase II Short-Term Study on Dapagliflozin Shows Results on,Safety, Tolerability and Glycemic Markers in Subjects With Type 2,Diabetes

-- Additional Findings Reported on Glucose Homeostasis Effects in Normal and Diabetic Rats --

CHICAGO, June 25, 2007 /PRNewswire-FirstCall/ -- In a 14-day, Phase IIa study of the safety profile of multiple doses of the investigational compound dapagliflozin, a selective inhibitor of the Sodium-Glucose Transporter 2 (SGLT2) administered alone or concomitantly with metformin in subjects with Type 2 diabetes, no discontinuations due to adverse events and no serious adverse events were reported. The study, presented this week at the annual meeting of the American Diabetes Association, also reported that dapagliflozin, in development by Bristol-Myers Squibb Company and AstraZeneca , statistically significantly reduced fasting serum glucose (FSG) and post challenge glucose excursion in subjects with Type 2 diabetes.

The data were from a double-blind, placebo-controlled, randomized, parallel-group study of 47 subjects with an established diagnosis of Type 2 diabetes (ages 18-77) who were either drug-naive or on a stable dose of metformin for at least 4 weeks prior to randomization with hemoglobin A1C levels between 6 and 10 percent with a FSG of less than or equal to 240 mg/dL. Subjects were randomized to receive either placebo (n=8) or dapagliflozin 5 mg (n=11), 25 mg (n=12), or 100 mg (n=16) once daily for 14 days in addition to their stable metformin dose and/or diet alone in an in-patient clinical research unit. The primary endpoint of the study was to assess both the safety and tolerability profiles of multiple doses of dapagliflozin in subjects with Type 2 diabetes. The secondary endpoints of the study included assessing the fasting serum glucose and post challenge glucose excursion. The presentation, "Dapagliflozin, a Selective Inhibitor of the Sodium-Glucose Uptake Transporter 2 (SGLT2), Reduces Fasting Serum Glucose and Glucose Excursion in Type 2 Diabetes Mellitus Patients Over 14 Days", was presented by Bernard Komoroski, PharmD, Ph.D., Senior Research
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