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news.Bristol-Myers Squibb has released findings from a 24-week Phase 3 clinical study which demonstrated that the investigational drug Dapagliflozin, administered as a monotherapy, showed mean reductions at 5mg and 10mg doses once daily in the primary endpoint of glycosylated hemoglobin levels (HbA1c) in treatment-naive adult patients with newly diagnosed type 2 diabetes, compared to placebo.
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Dapagliflozin, an investigational compound, is a potential sodium-glucose cotransporter-2 (SGLT2) inhibitor currently in Phase 3 trials under joint development by Bristol-Myers Squibb Company and AstraZeneca.
The study also demonstrated reductions in the secondary endpoint of fasting plasma glucose (FPG) and total body weight compared to placebo in these patients.
Signs, symptoms and other reports suggestive of urinary tract infections (UTIs) and genital infection were more frequently noted in the Dapagliflozin arms and rarely led to treatment discontinuation. No major episodes of hypoglycemia were reported in the study.
Ele Ferrannini, MD, professor of internal medicine, department of internal medicine, University of Pisa School of Medicine (Italy), said: “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.”