LONDON (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) and AstraZeneca (AZN) Saturday announced results from a 78-week study extension of a latestage trial of their investigational compound dapagliflozin for the treatment of Type 2 diabetes.
Results revealed a reduction in sugar levels, even as malignancies such as bladder and breast cancers were observed.
In the extension trial, data showed that dapagliflozin plus metformin sustained greater mean reductions from baseline in blood sugar levels in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin over 102 weeks.
Dapagliflozin is an experimental drug being studied by Bristol-Myers Squibb in partnership with AstraZeneca as a potential treatment for type 1 and 2 diabetes.
A New Drug Application for dapagliflozin was accepted for review by the U.S. Food and Drug Administration in March 2011 with a Prescription Drug User Fee Act date set for October 28, 2011. In addition, a Marketing Authorisation Application was validated by the European Medicines Agency in January 2011.
If approved, dapagliflozin - an inhibitor of SGLT2, a target in the kidney - would potentially be the first in a new class of insulin-independent, oral type 2 diabetes agents.
The latestage study comprised a 24-week Phase 3 randomized, double-blind, placebo-controlled trial with a 78-week extension. The study involved 546 adults with type 2 diabetes.
The 78-week extension was to assess the safety of long-term treatment with dapagliflozin, as well as changes from baseline in HbA1c, fasting plasma glucose and weight over 102 weeks of treatment.
The companies noted that the reductions seen in the study ranged from -0.48 percent in patients receiving dapagliflozin 2.5 mg plus metformin to -0.78 percent in patients receiving dapagliflozin 10 mg plus metformin, as compared to 0.02 percent in patients taking placebo plus metformin.
In the study, one patient treated with dapagliflozin 5 mg was diagnosed with transitional cell bladder cancer. One woman treated with 10 mg dapagliflozin was diagnosed with breast cancer.
Adverse events, serious adverse events and adverse events leading to discontinuation reported in the study were balanced across treatment groups, with events suggestive of genital infections and urinary tract infections more common in the dapagliflozin groups.
Other commonly occurring events included back pain, influenza, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, renal impairment or failure and events of hypoglycemia.
The results were presented today at the 71st American Diabetes Association Scientific Sessions.
Additionally, the companies gave an update on malignancies in the overall dapagliflozin safety profile. Nine bladder cancers have been observed in 5,478 patients on dapagliflozin and one bladder cancer has been observed in 3,156 patients in control groups. Nine breast cancers have been observed in 2,223 women on dapagliflozin and one has been observed in 1,053 women in control groups. All were diagnosed within a year after study start.
The companies said these clinical and preclinical data have been shared with FDA and other health authorities and will be reviewed fully at the scheduled Endocrinologic and Metabolic Drugs Advisory Committee on July 19, 2011.
Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. In 2010, diabetes was estimated to affect nearly 300 million people.
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