Bristol-Myers Squibb, AstraZeneca: Dapagliflozin meets trial endpoints

PRINCETON, N.J. An investigational drug used by Type 2 diabetes treatment-naive adult patients showed statistically significant reductions in glycosylated hemoglobin levels, according to a study published in Diabetes Care.

Dapagliflozin was administered as a monotherapy for 24 weeks in a phase 3 trial, under joint development by Bristol-Myers Squibb and AstraZeneca. The compound is an investigational, potential first-in-class sodium-glucose cotransporter-2 inhibitor. SGLT2 inhibitors facilitate the elimination of glucose by the kidney, which should result in lowering serum glucose levels, the drug makers said.

The study of 485 individuals (ages 18 to 77 years) was designed to assess the efficacy and safety of dapagliflozin in treatment-naive patients with newly diagnosed Type 2 diabetes and inadequate glycemic control with diet and exercise alone. The data represented findings from a 24-week, parallel-group, double-blind, placebo-controlled phase 3 study, with a two week diet/exercise placebo lead-in. Throughout the study, all patients received diet and exercise counseling per American Diabetes Association recommendations. By week 24, the HbA1c levels of the study subjects decreased, thus meeting the study's endpoints.

“These findings of dapagliflozin as a monotherapy, together with an additional phase 3 study of dapagliflozin in combination with metformin, which was presented at the 2009 European Association for the Study of Diabetes annual meeting, show the potential of this agent to help patients with Type 2 diabetes,” said Ele Ferrannini, professor of internal medicine at the University of Pisa School of Medicine in Italy.