Bristol-Myers announced that findings from a 24-week Phase 3 clinical study, published online in the latest issue of Diabetes Care, demonstrated that the investigational drug dapagliflozin, administered as a monotherapy, achieved statistically significant mean reductions at 5 mg and 10 mg doses once daily in the primary endpoint of HbA1c levels in treatment-naïve adult patients with newly diagnosed type 2 diabetes. The study also showed reductions in the secondary endpoint of fasting plasma glucose (FPG) and total body weight compared to placebo in these patients.
Dapagliflozin, an investigational compound, is a potential first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor currently in Phase 3 trials under joint development by Bristol-Myers Squibb Company and AstraZeneca as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes.