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Diabetes Reversed with Investigational Weight Loss Drug

Posted: Wednesday, December 28, 2011

Slightly more than a year of treatment with an investigational obesity drug that the FDA rejected for approval last year reversed type 2 diabetes in 15% of subjects.
The drug, which has the proposed name Qnexa (developed by Vivus, Mountain View, California), is a controlled-release combination of phentermine, an appetite suppressant, and topiramate, an anticonvulsant.

Nancy J.V. Bohannon, MD, director of clinical research in the cardiovascular risk reduction program at St. Luke's Hospital in San Francisco, California, who presented the findings, stated that, "We need more options to treat the twin epidemics of diabetes and obesity."

In a subanalysis of the previously published CONQUER trial (Lancet. 2011;77:1341-1352), researchers examined the effect of 2 different doses of the drug on a subset of 146 adults with type 2 diabetes and a body mass index (BMI) of 35 kg/m˛ or higher.

The mean BMI of participants was 39 to 40 kg/m˛, the mean duration of their diabetes was 4 years, 65% were female, and diabetes treatment in the group included diet and exercise, with about 50% using metformin.

After a titration period of 4 weeks, subjects were randomized to receive 52 weeks of placebo (n = 58), a half dose daily of the study drug (phentermine 7.5 mg/topiramate 46 mg; n = 24), or a full dose daily (phentermine 15 mg/topiramate 92 mg; n = 64).

At the end of the study period, subjects on the low-dose medication had a weight loss of 6.6% (P < .05) and those on the high dose had a 12.1% loss (P < .0001); in the placebo group, weight loss was 2.8%.

The researchers measured the drug's impact on excess weight, defined as the amount of weight above an ideal BMI of 25 kg/m˛. Compared with subjects on placebo, who lost 7.4% of their excess weight, subjects on the low-dose medication lost 17.8% (P <.05) and those on the full dose lost 32.6% (P <.0001).

"Fasting blood sugar and hemoglobin A1c showed statistically significant changes from baseline at the full dose," said Dr. Bohannon. Resolution of diabetes, defined as the absence of clinical and laboratory manifestations of diabetes was seen in 1.7% of subjects on placebo, 8.3% of those on the half dose of medication, and 15.4% of those on the full dose.

The most common adverse events included constipation, paresthesia, insomnia, dry mouth, headache, and dysgeusia, she said.

In the FDA's complete response letter rejecting the company's New Drug Application, teratogenicity was mentioned as a major concern, as was elevated heart rate. Metabolic acidosis, depression, anxiety, and sleep disorders, along with attention, memory, language, and other cognitive disorders have been mentioned.

Compared with recent studies on laparoscopic banding for the treatment of obesity, an excess weight loss of 32.6% seen with the full dose of medication measures up well, said Dr. Bohannon.

A recent study showed a similar 32% loss in diabetic subjects 1 year after gastric banding (Surg Obes Relat Dis. 2010;6:132-137); another study showed a 47% loss 2 years after surgery (Dixon JB et al. Obes Rev. Published online August 31, 2011).

"These are promising results. The question is: Will they be able to show enough safety so the FDA will be comfortable enough to approve it? The hope is that they will," said Francine Ratner Kaufman, MD, professor of pediatrics at the Keck School of Medicine, University of South California, and head of the Center for Diabetes, Endocrinology and Metabolism at the Children's Hospital, both in Los Angeles, who cochaired the session.

Vivus resubmitted the New Drug Application for phentermine/topiramate. A decision on the approval is expected in April 2012.

Source: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=11928&catid=53&Itemid=8, International Diabetes Federation (IDF) World Diabetes Congress 2011: Abstract O-0534. Presented December 7, 2011.

 
 
 
 
 
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