Dapagliflozin in addition to insulin improves glycemic control in type 2 diabetics

Jun 29 2010

Results from a 24-week Phase 3 clinical study demonstrated that the addition of the investigational drug dapagliflozin achieved reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c), in inadequately controlled type 2 diabetes patients who were treated with insulin (with or without oral anti-diabetes medications (OADs)), compared to placebo plus insulin (with or without OADs). The study also demonstrated that dapagliflozin achieved reductions in the secondary endpoints that evaluated the change in total body weight from baseline, change from baseline in mean daily insulin dose, and change from baseline in fasting plasma glucose (FPG). Generally, adverse events, serious adverse events and study discontinuations were similar across all treatment groups. Signs, symptoms and other reports suggestive of urinary tract and genital infections were more frequently noted in the dapagliflozin treatment arms compared to placebo and rarely led to discontinuation. Results from the 24-week study were presented at the 70th American Diabetes Association (ADA) Annual Scientific Sessions.

“The Phase 3 data on glycemic and weight parameters presented today suggest that further study of dapagliflozin in this patient population is warranted.”

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 (NYSE: BMY) and AstraZeneca (LSN, NYSE: AZN) as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes. SGLT2 inhibitors facilitate the elimination of glucose by the kidney, which should result in lowering serum glucose levels.

"Many type 2 diabetes patients who are treated with insulin are not able to achieve their blood sugar goals," said John Wilding, DM, FRCP, Professor of Medicine and Honorary Consultant Physician, Head of Diabetes and Endocrinology Clinical Research Unit, University Hospital Aintree (UK). "The Phase 3 data on glycemic and weight parameters presented today suggest that further study of dapagliflozin in this patient population is warranted."

Data from the 48 week follow-up of the same study will be presented as a late breaker at the ADA Scientific Sessions.