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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

Investigator, Bristol-Myers Squibb.

On Day 13, the FSG was significantly reduced in participants receiving dapagliflozin with or without metformin as compared to their FSG levels two days prior to first dose: -14.5 percent (p-value less than 0.05), -17.3 percent (p-value less than 0.05), -21.9 percent (p-value less than 0.001) for dapagliflozin at 5 mg, 25 mg and 100 mg, respectively. FSG was reduced by -6.3 percent in participants receiving placebo with or without metformin.

There were no discontinuations due to adverse events and no serious adverse events were reported. Adverse events included two events of hypoglycemia in subjects receiving dapagliflozin co-administered with metformin. There were two events of vulvovaginal infection in the study (one subject receiving dapagliflozin alone and one subject receiving dapagliflozin+metformin). Adverse events occurred with similar frequency in subjects receiving dapagliflozin or placebo. The most frequently reported adverse events were: constipation (n=7; 1/19 on dapagliflozin+metformin, 3/20 on dapagliflozin alone, 2/6 on placebo+metformin, 1/2 on placebo alone), nausea (n=5; 4/19 on dapagliflozin+metformin, 1/6 on placebo+metformin), and diarrhea (n=4; 3/19 on dapagliflozin+metformin, 1/6 on placebo+metformin).

Preclinical Data Also Presented at 2007 American Diabetes Association Annual Meeting

In a second presentation this week - "Dapagliflozin, A Selective SGLT2 Inhibitor, Improves Glucose Homeostasis in Normal and Diabetic Rats" by Jean Whaley, Sc.D., Director, Diabetes Drug Discovery, Bristol-Myers Squibb, the effect of dapagliflozin on glucose homeostasis in normal and diabetic rats was reported. In diabetic rats, dapagliflozin acutely induced renal glucose excretion at doses ranging from 0.01-1.0 mg/kg of body weight without inducing hypoglycemia. Additionally, as early as two hours after a single oral dose, there was a statistica
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