RIO-Diabetes was a phase III, multinational, multicenter, radnomized, double-blind and placebo-controlled trial carried out at 151 centers in 11 countries.

The 1,045 participants enrolled in the trial had Type 2 diabetes, and were 51 percent male, mean age 56 years, mean Body Mass Index (BMI) of 34, and mean A1c of 7.5 percent.

Two-thirds of the patients were taking Glucophage (metformin) as a therapy for diabetes, and the rest were taking sulfonylurea.

Patients were randomized to receive for one year either a low daily, fixed dose of 5 mg of Acomplia, a higher dose of 20 mg of Acomplia, or a placebo along with a reduced calorie diet.

Patients on the higher dose of Acomplia were far more successful than patients on the lower dose or in the placebo control group. In fact, researchers said, the differences in results for those on placebo vs. the low rimonabant dose were so minor that only higher dose results thus far have been.

Patients in this study treated with the higher dose of Acomplia lost an average of 11.7 lbs compared to 3 lbs for patients in the placebo group. In addition, patients treated with the higher Acomplia dose saw a reduction in waist circumference of 2 inches versus 0.7 inches for those taking the placebo.

Among all patients who entered the RIO-Diabetes study, patients on the higher dose of rimonabant achieved an HbA1c reduction of 0.6 percent from a baseline value of 7.3 percent compared to an increase of .1 percent for those taking the placebo -- a difference of .7 percent.

Forty three percent of patients on higher Acomplia dose got their A1c level below 6.5 percent -- the target treatment goal of the American Association of Clinical Endocrinologists -- compared to only 21 percent on the placebo.

Among patients whose baseline A1c was higher than 7 percent, 52.7 percent of patients on the higher Acomplia dose got it below 7 per cent -- the target treatment goal of the American Diabetes Association -- by the end of the study compared to 26.8% of patients on a placebo.

Researchers said a statistical analysis indicated that .3 percent of the improvement in HbA1c observed with the higher rimonabant dose was attributable to wait loss and .4 percent of the improvement in HbA1c could not be explained by weight loss and thus was an independent effect attributable to Acomplia.

HDL-cholesterol and triglycerides were also significantly improved in patients treated with the higher dose of Acomplia throughout the one year period.

Among all patients who entered the study, the good HDL-cholesterol increased by 15.4 percent in the group taking the higher Acomplia dose vs 7.1 percent in the placebo group.

Furthermore, triglycerides were reduced by 9.1 percent in patients treated with the higher Acomplia dose compared to an increase of 7.3 percent in the placebo group.

In addition to the improvements in lipid profiles, the number of patients meeting the criteria for metabolic syndrome -- a cluster of conditions linked to an increased risk of cardiovascular disease -- was reduced by 18.9 percent in the group taking the higher Acomplia dose compared to 7.6 percent in the group taking a placebo.

Contributing to that was a small decline of 0.8 mmHg in systolic blood pressure in the higher dose rimonabant group compared to a 1.6 mmHg increase in the placebo group. The difference in diastolic blood pressure between the two groups was not statistically significant.

Side effects were mainly mild and transient, the researchers said, and most frequently included nausea (experienced by 12.1 percent of patients on the higher Acomplia dose), dizziness (experienced by 9.1 percent), diarrhea (experienced by 7.4 percent), vomiting (5.9 percent), hypoglycemia (5.3 percent), fatigue (5.3 percent) and anxiety (5. 0 percent).

These side effects, which mostly occurred within the first few weeks, led to a drop-out rate of 3.3 percent among those on the higher dose of Acomplia compared to 0.9 percent in the placebo group.

"The RIO-Diabetes trial results indicated that rimonabant delivered a clinically meaningful reduction in HbA1c and may offer a broad range of cardiometabolic risk factor improvements that are essential for the comprehensive management of people with type 2 diabetes," concluded Dr. Andre Scheen of the Academic Hospital of Liege, Belgium, principal researcher.