American Diabetes Association Scientific Sessions, In Brief
Executive Summary
Bristol/AstraZeneca release saxagliptin results: Dipeptidyl-peptidase-4 inhibitor demonstrates statistically significant improvement in glycemic control in patients with type 2 diabetes compared to metformin alone, Bristol-Myers Squibb and AstraZeneca report in the first presentation of Phase III data on saxagliptin June 25 during American Diabetes Association scientific sessions in Chicago. Results showed that after 24 weeks, patients taking saxagliptin and metformin had a statistically significant decrease in HbA1C levels compared to the metformin alone, the primary endpoint. Reductions in HbA1C were 0.73 percent, 0.83 percent and 0.72 percent in patients taking 2.5 mg, 5 mg and 10 mg doses, respectively. Bristol and AstraZeneca have said they intend to submit an NDA for the drug in mid-2008. Firms signed a deal worth $1 billion in January to co-develop diabetes therapies (1"The Pink Sheet" Jan. 15, 2007, p. 16). Last October, Merck's Januvia (sitagliptin) became the first DPP-4 inhibitor to be approved by FDA (2"The Pink Sheet" Oct. 23, 2006, p. 6)...