Phase IIa Study Assessing Safety And Tolerability Of Dapagliflozin After 14 Days As Add-on To Insulin In Adult Patients With Type 1 Diabetes Presented At The 2013 American Diabetes Association Scientific Sessions®
AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a two-week Phase IIa pilot study evaluating dapagliflozin added to insulin in 70 adult patients with sub-optimally controlled type 1 diabetes. Results from this study showed that in patients treated with dapagliflozin, no subjects discontinued due to lack of glycemic control, few genital and urinary tract infections were reported and hypoglycemia was observed in all treatment groups. In addition, mean daily blood glucose derived from 7-point glucose measurements trended downward in all treatment groups through day seven and reductions in total daily insulin dosing at day seven were observed with dapagliflozin. These findings will be presented Sunday, June 23, in a late-breaking poster session at the 73 rd Scientific Sessions ® of the American Diabetes Association in Chicago.
In this study, there was one case of major hypoglycemia in the dapagliflozin 10 mg group that led to discontinuation. The proportion of adverse events (excluding hypoglycemia events) was 61.5% for the placebo group and 38.5%, 46.7%, 50.0% and 40.0% for the dapagliflozin 1, 2.5, 5 and 10 mg groups added on to background insulin, respectively. The proportion of hypoglycemia events was 61.5% for the placebo group and 92.3%, 60.0%, 78.6% and 66.7% for the dapagliflozin 1, 2.5, 5 and 10 mg groups added on to background insulin, respectively. There were two cases of urinary tract infection reported (one in the placebo group and one in the dapagliflozin 2.5 mg group) and two cases of genital infections (one in the dapagliflozin 1 mg group and one in the dapagliflozin 5 mg group). One serious adverse event was reported (gastroparesis) in the dapagliflozin 5 mg group, which was not considered treatment-related, and was the only adverse event that led to discontinuation.
“Many people with type 1 diabetes may benefit from other treatment options in addition to insulin,” said Robert Henry, M.D., director, Center for Metabolic Research VA San Diego Healthcare System and primary study investigator. “These preliminary data with dapagliflozin added on to insulin are encouraging and support the need for further studies.”
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