Results from a 24-week Phase III study showed that saxagliptin, a selective, reversible inhibitor of the dipeptidyl peptidase (DPP-4) enzyme in development by Bristol-Myers Squibb Company and AstraZeneca produced significant reductions in key measures of glucose control, A1C, FPG and PPG in treatment naïve people with type 2 diabetes compared to placebo. Over 24 weeks, saxagliptin had an adverse event profile that appeared similar to placebo.
“Diabetes is a serious and chronic condition that affects nearly 21 million people in the U.S. and, unfortunately, this number is only going to rise,” said Julio Rosenstock, MD, Director of Dallas Diabetes & Endocrine Center at Medical City. “New therapies need to be researched and developed to help treat this growing epidemic.
The data represent findings from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 401 people with type 2 diabetes (ages 18-77) who were treatment naïve and whose A1C level was greater than or equal to 7 percent and less than or equal to 10.
After 24 weeks, individuals receiving ONGLYZA™ (saxagliptin) 2.5 mg, 5 mg and 10 mg demonstrated a significant mean change in A1C from baseline to -0.6 percent, -0.6 percent and -0.7 percent, respectively (p-value less than 0.0001). Reductions in A1C levels were seen as early as four weeks after initiation of saxagliptin treatment, the first scheduled A1C measurement point. The percentage of individuals receiving saxagliptin 2.5 mg, 5 mg and 10 mg or placebo who achieved the American Diabetes Association’s recommended A1C of less than 7 percent at Week 24 was 35 percent, 38 percent and 41 percent, respectively, Saxagliptin demonstrated significant reductions versus placebo in FPG and PPG at all doses from baseline to Week 24.
No cases of confirmed hypoglycemia (symptoms of hypoglycemia with a fingerstick glucose less than or equal to 50 mg/dL) were reported. The proportion of reported hypoglycemic events was similar in the saxagliptin-treatment arms (5.2 percent) and PBO (6.3 percent).
The Companies plan to submit a New Drug Application (NDA) in the United States in mid 2008.
Presented at the American Diabetes Association 68th Scientific Sessions held in San Francisco, California.