Diet drug Acomplia (rimonabant) significantly improved the blood glucose control of type 2 diabetic patients in a major clinical trial called ARPEGGIO, researchers reported on June 10th at the 68th Scientific Sessions of the American Diabetes Association.
The researchers said that patients in the multicenter trial who were given a 20 mg daily dose of Acomplia in addition to their daily insulin saw their HbA1c (a standard measure of glucose control) improve by .89 percent, tripling the number of diabetics reaching the recommended 7% HbA1c level.
Glucose control was three times more pronounced when rimonabant was added to the daily regime than insulin and lifestyle advice alone.
The 368 type 2 diabetics participating in the 11-month trial, carried out at 60 centers in 12 countries, had been treated with insulin for an average duration of six years prior to entering the study.
“The ARPEGGIO trial demonstrated that there is still room for significant improvement in diabetic patients who despite several years of standard therapies including insulins, in addition to diet and exercise measures, are not well controlled,” said Dr. Priscilla L. Hollander of Baylor University Medical Center.
Sanofi continues to plan to resubmit Acomplia for U.S. FDA approval for treatment of diabetes next year, even though last year it abandoned its bid to get rimonabant approved for weight control after serious concern was raised over psychiatric side effects.
In the ARPEGGIO trial, researchers said anxiety was reported by 14 percent of the patients taking rimonabant compared to 5 percent in the control group, and depression was reported by 14 percent taking Acomplia compared to 7.5 percent in the control group.
Most of the diabetic patients enrolled in the trial had a medical history of depression, Sanofi said.
ARPEGGIO was designed to assess the value of rimonabant as an add-on therapy for patients with type 2 diabetes who are treated with insulin, yet require further glycemic control.
In addition to the significant improvement of HbA1c, patients taking Acomplia also had a statistically significant body weight loss, losing over five pounds more during the trial compared to those on a placebo.
|