Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in glycosylated hemoglobin levels (HbA1c) in adult patients with type 2 diabetes compared to glimepiride alone. The study also demonstrated that dapagliflozin plus glimepiride achieved reductions in the secondary efficacy endpoints of change in total body weight, oral glucose tolerance test (OGTT) and fasting plasma glucose (FPG) levels from baseline at week 24 compared to placebo plus glimepiride. More people taking dapagliflozin and glimepiride were able to achieve a target HbA1c of less than 7% compared to patients taking glimepiride alone. Results from the study were presented at the 46th European Association for the Study of Diabetes (EASD) Annual Meeting.
“This study, which adds to the Phase 3 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.”
Overall, the frequency of drug-related adverse events was reported at a similar rate between treatment groups, although signs, symptoms and other reports suggestive of genital tract infections, but not urinary tract infections, were more frequently reported in dapagliflozin treated subjects.
Dapagliflozin, an investigational compound, is a first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor and is 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. SGLT2 inhibitors, which act independently of insulin mechanisms, facilitate the excretion of glucose and associated calories in the urine, thereby lowering blood glucose levels.
"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, Professor, Department of Internal Diseases Diabetology & Nephrology Silesian Medical University, Zabrze (Poland), principal investigator of the study. "This study, which adds to the Phase 3 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."
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