Investigational drug dapagliflozin can improve glycaemic control in treatment-naive adults with type 2 diabetes when used as a monotherapy, a Phase III study carried out at Princeton University, US, has found.
Dapagliflozin is a potential sodium-glucose cotransporter-2 inhibitor that is being trialled jointly by Bristol-Myers Squibb and AstraZeneca.
The drug demonstrated statistically significant mean reductions in its primary endpoint – lowering glycosylated haemoglobin levels – compared to a placebo when given once daily, at both 5mg and 10mg doses.
Reductions in the secondary endpoint of fasting plasma glucose and total body weight compared to a placebo were also noted.
The signs and symptoms of urinary tract and genital infections were more often noted in the dapagliflozin arms of the trial, but rarely led to treatment discontinuation.
Ele Ferrannini, professor of internal medicine at the University of Pisa, said these findings, along with an additional Phase III study of dapagliflozin in combination with metformin, showed its the potential to help patients with type 2 diabetes.