Sanofi-aventis reports positive results from diabetes trial

Arpeggio, performed in 60 centers, throughout 12 countries, was a double-blind, randomized, parallel-group, fixed-dose, two-arm, controlled trial (rimonabant 20mg/once daily versus control). Patients had type 2 diabetes treated with insulin (greater than or equal to 30U/day for at least four weeks) with an HbA1c greater than or equal to 7%.

The primary objective of the study was to assess the effect of rimonabant 20mg/day on HbA1c over a period of 48 weeks (336 days) in patients with type 2 diabetes treated with insulin. Other measures included body weight, waist circumference, serum lipids, glycemic measures and adverse event data.

Rimonabant 20mg significantly improved HbA1c by 0.89% from the baseline value, and 0.64% 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 in this 11-month trial had been treated with insulin for an average duration of six years prior to entering 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 hypoglycemia were reported with rimonabant 20mg/day and control, eight and seven cases, respectively. An increase in hemoglobin A1c of 1% was generally associated with a 24% increase in the risk of death from any cause for men and a 28% increase for women.