Bristol-Myers Squibb Company and AstraZeneca announced results from a Phase 3 clinical study which showed that reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) seen at 24 weeks with the investigational compound dapagliflozin added to existing glimepiride (sulphonylurea) therapy, compared to placebo added to glimepiride, were maintained at 48 weeks in adults with type 2 diabetes. These results, presented during the International Diabetes Federation (IDF) 2011 World Diabetes Congress in Dubai, UAE, are from a 24-week extension period of a 24-week trial. The initial 24-week results were presented at the 46th European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden in September 2010.
In addition to maintaining reductions in blood sugar levels, the 48-week study reported that patients taking dapagliflozin added to glimepiride maintained reductions in fasting plasma glucose levels (FPG), post-prandial glucose (PPG) and total body weight.
Events suggestive of genital infections were more common in patients taking dapagliflozin added to glimepiride compared to placebo added to glimepiride. Events suggestive of urinary tract infections were similar for dapagliflozin and placebo groups in this trial. These events were proactively monitored and were generally mild to moderate in intensity, with most patients responding to standard treatment.
“Given that patients with type 2 diabetes often need multiple therapies to help manage blood sugar levels over the course of this progressive disease, it is important to assess the ability of new compounds to work in combination with commonly prescribed anti-diabetic treatments,” said Krzysztof Strojek, M.D., Department of Internal Diseases, Diabetology and Nephrology, Silesian Medical University (Poland). “This study demonstrated that the addition of dapagliflozin to existing glimepiride therapy maintained reductions in blood sugar levels over 48 weeks.”
Dapagliflozin, an inhibitor of SGLT2, a target in the kidney, is under joint development by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin, as an adjunct to diet and exercise, is being investigated to evaluate its safety and efficacy in improving glycemic control in adults with type 2 diabetes, for use as a monotherapy and in combination with other anti-diabetic agents. A Marketing Authorisation Application (MAA) was validated by the European Medicines Agency (EMA) in January 2011. In March 2011, the U.S. Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for dapagliflozin for the treatment of adults with type 2 diabetes mellitus. The FDA Prescription Drug User Fee Act (PDUFA) date is January 28, 2012.
Date: December 8, 2011
Source: Bristol-Myers Squibb Company and AstraZeneca
