( 37 percent 44 percent and 44 percent ...)Data Demonstrated Saxagliptin Added to Metformin Improved Glycemic,Control in Subjects with Type 2 Diabetes Compared to Metformin,Alone,Health

37 percent, 44 percent and 44 percent for the 2.5 mg, 5 mg and 10 mg doses of saxagliptin respectively (p-value at all dosage levels less than 0.0001 vs. placebo+metformin).

In this study, the number of subjects with investigator-reported hypoglycemia, with or without confirmation, were: 9 on placebo+metformin, and 15, 10 and 7, for 2.5 mg, 5 mg, and 10 mg on saxagliptin+metformin, respectively. There was one subject with confirmed hypoglycemia in each of the four arms (as measured by blood glucose less than or equal to 50 mg/dL with symptoms). The most common adverse events seen in more than 5 percent of subjects randomized to either placebo+metformin or saxagliptin+metformin (all doses combined) were: nasopharyngitis 7.8% vs. 8.7 %, headache 7.3% vs. 8.0%, diarrhea 11.2% vs. 7.1%, upper respiratory infection 5.0% vs. 6.6%, influenza 7.3% vs. 6.0%, and urinary tract infection 4.5% vs. 5.1%.

Phase I Studies Also Presented at 2007 American Diabetes Association Annual Meeting

In the presentation "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-Daily Oral Doses of Saxagliptin for 2 Weeks in Type 2 diabetic and Healthy Subjects" by David Boulton, Ph.D., Principal Scientist, Bristol-Myers Squibb, results from two Phase I studies were reported. Study 1 was conducted in subjects with Type 2 diabetes; Study 2 was conducted in healthy subjects. Both studies were placebo-controlled, randomized,
double-blind, sequential, multiple ascending dose studies. The primary objective of these two studies was to assess the safety and tolerability profiles of multiple daily oral doses of saxagliptin in subjects with Type 2 diabetes and in healthy subjects.

Study 1 consisted of 40 subjects (ages 18-70) who had been diagnosed with Type 2 diabetes for less than 10 years, had hemoglobin A1C in the range of 6.5 to 9.5 percent, and fasting plasma glucose in the range 125-250 mg/dL. Participants were randomized to receiv
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