AZ, BMS tout new batch of PhIII diabetes data for dapagliflozin

AstraZeneca and Bristol-Myers Squibb are adding a new chapter of positive Phase III data for their Type 2 diabetes drug dapagliflozin, the latest installment in the see-sawing story about their new approach to treating diabetes.

This latest data dump revolved around the combination of dapagliflozin and glimepiride, a standard therapy for diabetes. The combo approach performed better than glimepiride alone in lowering a common measure of blood glucose. Dapagliflozin plus glimepiride also "achieved reductions in the secondary efficacy endpoints of change in total body weight, oral glucose tolerance test and fasting plasma glucose levels from baseline at week 24 compared to placebo plus glimepiride."

The drug inhibits the sodium-glucose transporter-2 system, one of a new class of SGLT2 inhibitors now in the clinic. The kidneys rely on the system to reabsorb glucose circulated in the blood.

"With Type 2 diabetes, we often see a progressive deterioration of glycemic control in patients, which may require treatment intensification with additional drug therapy," said Krzysztof Strojek, the principal investigator of the study. "This study, which adds to the Phase III data available for this investigational compound, demonstrated that dapagliflozin improved glycemic control, as measured by HbA1c, FPG and PPG, in adult patients with type 2 diabetes when added to the commonly used oral diabetic agent - glimepiride."

It hasn't all been clear sailing for the drug, though, After acing its first late-stage study analysts were disappointed by the moderate weight loss recorded in the second Phase III. Some analysts expect sales of an approved therapy could hit about $300 million in 2015.

- here's the AZ/BMS release
- and here's the Dow Jones story

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