SERENADE (Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients) was a six-month phase IIIb, multinational, multicenter, randomized, double-blind and placebo-controlled trial carried out at 56 centers in the United States, Germany, Argentina, Chile, Hungary, Poland and the Netherlands.

The 278 participants enrolled in the trial had Type 2 diabetes for at least two months but less than three years, had an HbA1c level of more than 7 percent but less than 10 percent, and had not been treated with another diabetes drug within six months of the start of the trial.

Patients were randomized to receive for six months either a daily dose of 20 mg of Acomplia, or a placebo along with diet based on the American Diabetes Association recommendations. Those who were overweight also had a 600 calorie reduction in their diet.

The trial showed that HbA1c levels in patients with a baseline average of 7.9 who took a 20 mg Acomplia pill once daily fell 0.8 percentage points compared to a drop of 0.3 points in those taking a placebo.

Patients with an HbA1c level of at least 8.5 when they started taking Acomplia saw their their blood sugar level decrease 1.9 points compared to 0.7 points in patients on a placebo.

Over 50 percent of the patients in the Acomplia arm of the trial achieved HbA1c levels of below 7 percent, the target level for good glucose control recommended by the American Diabetes Association.

The patients taking Acomplia in the trial lost on average 14.8 pounds of weight compared to 5.95 pounds for those on a placebo. The waist circumference of patients on Acomplia shrank an average of 2.34 inches compared to .93 inch for those on a placebo.

Patients in the Acomplia arm of the trial also saw improvements in multiple cardiometabolic risk factors.

Dr Julio Rosenstock (University of Texas Southwestern Medical School, Dallas), who presented SERENADE, said the issue of whether rimonabant should now be labeled an oral antidiabetic agent “was an issue of semantics.” The new study met its primary objective, and the findings on HbA1_c were “robust,” he said during a company-sponsored webcast of the results. “There was a lot of consistency with the RIO-Diabetes study, where blood-sugar control was a secondary end point,” he noted.

He believes that rimonabant has “tremendous potential” in the treatment of diabetes. “Every time we improve diabetes control, we have a price to pay in terms of weight gain. But with rimonabant we see an improvement in HbA1_c with important reductions in weight–that is what makes it different and distinct.” Rimonabant also showed improvements in multiple cardiometabolic risk factors in the trial, and there is hope that it can be successfully combined with other antidiabetic drugs, he said.

December 6, 2006 (Cape Town, South Africa) – Rimonabant produces significant improvements in blood sugar beyond what would be expected from its effects on weight loss, a new study in treatment-naive diabetics shows [1]. The Study Evaluating Rimonabant Efficacy in Drug-Naive Diabetic Patients (SERENADE) is the second study of rimonabant in diabetics but the first with HbA1_c as a primary end point; the results were reported yesterday at the International Diabetes Federation 19th World Diabetes Congress