Overweight or obese people with diabetes who took the drug Acomplia for a year, in combination with diet and exercise, had modest but significant improvements in blood sugar control and cholesterol, along with modest weight loss.
Acomplia has not yet been approved for sale in the U.S., but it is being sold in Europe.
In the new study, 1,047 overweight or obese people with type 2 diabetes who were already on an oral diabetes drug were randomly assigned to also take either a placebo, 5 milligrams of Acomplia, or 20 milligrams of Acomplia daily.
After a year of treatment, patients who took the higher dose of Acomplia had lost an average of 11.7 pounds, compared with 3 pounds among patients in the placebo group and 5 pounds among patients who took the lower dose of the drug.
The study appears in the Oct. 27 online edition of the journal The Lancet. It was funded by Acomplia's maker, Sanofi-Aventis. Sanofi-Aventis is a WebMD sponsor.
The researchers reported that improvements in cholesterol and blood sugar were twice what would have been expected from weight loss alone, indicating that the weight loss drug has an independent effect on these diabetes risk factors.
Second Opinion on Study
Two diabetes experts who wrote an editorial accompanying the study conclude that it is premature to assume that Acomplia has a direct impact on diabetes risk factors, over and above its ability to promote weight loss.
Stephen Cleland and Naveed Sattar also express concern about the high dropout rate among study participants. Of the 1,047 patients who were recruited, only 692 (66%) completed the one-year study.
The dropout rate was roughly the same for patients in all three arms of the study, and most patients did not drop out because of side effects.
But 11 patients (3%) who took the higher dose of Acomplia cited depressiondepression as a reason for dropping out of the study. None of the patients in the lower-dose arm of the study dropped out because of depression; three patients (0.9%) in the placebo arm dropped out for this reason.
The prescription weight loss drugs that are available in the U.S. are not routinely used for the treatment of type 2 diabetes because of worries about side effects.
Larry Deeb, MD, of the American Diabetes Association, tells WebMD that a safe and effective weight loss drug would be a welcome addition to the growing list of drugs used to treat type 2 diabetes.
"As a diabetes doctor I want my patients to follow a healthy lifestyle, which includes regular exercise and eating a healthy diet," he says. "This has benefits over and above the impact on blood sugar. But the reality is that far too few patients take this advice, so we need as many therapeutic options as we can get."
Acomplia may prove to be a useful drug for diabetes, he says, but it is far from a wonder drug.
"The weight loss in this study was modest, and that is also true of the impact on blood sugar and HDL cholesterolHDL cholesterol," he says.
Deeb directs the Diabetes Center at Tallahassee Memorial HealthCare hospital and he is president of medicine and science for the American Diabetes Association.
In an interview with WebMD, a spokeswoman for Sanofi-Aventis declined to comment on when an FDA ruling on the sale of Acomplia in the U.S. might be expected. But news reports have suggested that the FDA would act by the end of the year.