Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced data from the CORDiabetes trial for Contrave® (naltrexone sustained release (SR)/bupropion SR) showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.
Over twice as many patients lost at least 5% of their body weight on Contrave versus placebo on an intent-to-treat (ITT) basis (44.5% vs. 18.9% respectively), according to the data presented today by Dr. Priscilla Hollander, M.D., Baylor Medical Center, at an oral session of the 70th Scientific Sessions of the American Diabetes Association. Importantly, Contrave-treated patients experienced clinically significant reductions in A1C. Average baseline A1C, the standard test for monitoring glycemic control, of approximately 8.0% was reduced by 0.6% for Contrave compared to 0.1% for placebo. This translated to over 44% of Contrave patients reaching the American Diabetes Association (ADA) treatment target for A1C of less than 7%. In comparison, 26% of placebo patients reached the same threshold (p<0.001).
"It is well understood that weight loss is beneficial for glycemic control and slows disease progression in patients with type 2 diabetes," said Dr. Hollander, a lead investigator on COR-Diabetes. "The COR-Diabetes study demonstrated the potential utility of Contrave for obese patients with diabetes, where weight loss and weight management, coupled with a clinically meaningful improvement in glycemic control, improves overall health."
The impact on A1C was shown to be most profound in Contrave patients who started the trial with poor glycemic control. In fact, those patients who had a starting A1C greater than 8% exhibited an A1C improvement of -1.1%, compared with -0.5% in patients on placebo (p<0.01). In addition, significantly fewer patients taking Contrave were treated with diabetes rescue medication (22.3%) compared to placebo patients (35.2%), (p<0.01).
According to the ADA, diabetes affects 24 million Americans, a number that is projected to grow to 44 million over the next 25 years, driven largely by rising rates of obesity. The cost of treating the disease is expected to triple over the same time period. Obesity is the single greatest risk factor for type 2 diabetes; approximately 85% of patients with type 2 diabetes are overweight or obese.
Improvements in Markers of Cardiometabolic Risk
Patients treated with Contrave also showed improvements in a number of other measures of cardiometabolic risk, as shown in the table below:
The most frequently observed treatment-emergent adverse events in COR-Diabetes were nausea, vomiting, constipation and dizziness. Nausea was the leading adverse event resulting in discontinuation.
"The results of the COR-Diabetes study demonstrate the important role of weight loss and weight management as a cornerstone in the treatment of obese patients with type 2 diabetes," commented Dr. Dennis Kim, Orexigen's Senior Vice President of Medical Affairs.
Study Design
COR-Diabetes was a 56-week placebo-controlled, double-blind randomized trial of 505 overweight or obese patients with type 2 diabetes, whose A1C levels were between 7% and 10%>the United States participated in the study.
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