Sanofi-aventis announced the results of Arpeggio, the first trial of rimonabant in patients with type 2 diabetes, not adequately controlled with insulin therapy. These results were presented at the 68th Scientific Sessions of the American Diabetes Association, in San Francisco.
Rimonabant 20 mg significantly improved HbA1c (a standard blood measure value that is indicative of a patients' glucose for about two months) by 0.89 per cent from the baseline value, and 0.64 per cent over the control group (p<0.0001). Glucose control was three times more pronounced when rimonabant was added than insulin and lifestyle advice alone.
The 368 type 2 diabetes patients participating to this 11-month trial 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", declared Priscilla L. Hollander, MD, Baylor University Medical Center, Dallas, Texas, USA, and Coordinating Investigator of the study.
Fewer patients in the rimonabant group compared with the control group experienced serious treatment emergent adverse events (16.8% versus 19.3%, respectively). Anxiety was reported in 5% of the patients in the control arm versus 14% in the rimonabant arm. Depression (including depressed mood) was 7.5% in the control group versus 14% in the rimonabant group; most of the patients had a medical history of depression. Similar numbers of severe hypoglycaemia were reported with rimonabant 20 mg/day and control, 8 and 7 cases, respectively.
Arpeggio is part of the phase III b programme to study the selective CB1 blocker rimonabant (20 mg daily) versus control in the management of type 2 diabetes and cardiovascular disease. Arpeggio was designed to assess the efficacy of rimonabant 20 mg/day as an adjunct therapy in patients with type 2 diabetes who are treated with insulin, yet require further glycaemic control (as measured by HbA1c).