Bristol-Myers Squibb, AstraZeneca Release Dapagliflozin Phase 3 Trial Results

According to the study the addition of 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).

Dapagliflozin, an investigational compound, is a sodium-glucose cotransporter-2 (SGLT2) inhibitor currently in Phase 3 trials under joint development by Bristol-Myers Squibb and AstraZeneca as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes.

Dapagliflozin’s Phase 3 study was designed to assess the efficacy and safety of the drug in patients with inadequately controlled type 2 diabetes receiving treatment with a mean insulin dose of greater than or equal to 30IU for at least 8 weeks with or without concomitant OADs.

In the study, 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).

John Wilding, head of diabetes and endocrinology clinical research unit at University Hospital Aintree, UK, said: “The Phase 3 data on glycemic and weight parameters presented suggest that further study of Dapagliflozin in this patient population is warranted.”