Sanofi-Aventis has presented data from a Phase III trial of its new obesity drug Acomplia (rimonabant) which shows that treatment-naive patients with type 2 diabetes who received the drug experienced significant improvements in blood glucose control and weight loss, compared to those who took placebo.
In the Serenade study, data for which was presented at the World Diabetes
Congress in Cape Town, South Africa, 278 patients with type 2 diabetes who could not adequately control their disease with diet alone were randomised to receive placebo or Acomplia once daily for six months. Patients receiving the drug lowered their HbA1C (glycosylated haemoglobin - a measure of long-term glucose control) levels by 0.8% from a baseline value of 7.9, compared to a reduction of 0.3% for patients taking placebo.
Sanofi added that patients with a baseline HbA1C value of 8.5 or higher, and who received Acomplia, reduced their levels by 1.9%, compared to 0.7% in those who took placebo. The study also revealed that patients
who received Sanofi’s drug saw reductions in body weight of 6.7kg,
compared to 2.7kg for patients in the placebo group. The Acomplia group
also saw improvements in cardiometabolic risk factors such as a decrease
in waist circumference, higher HDL or ‘good’ cholesterol levels, and lower
triglyceride levels.
Glucose control independent of weight loss
Sanofi estimated that 57% of the improvements in HbA1c levels were
independent of the weight loss achieved, which could suggest that Acomplia
has a direct impact on this measure of blood glucose control.
Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center and
an investigator on the Serenade trial, said that “the management of type 2
diabetes should not only focus on controlling blood sugar levels, but also
improve other risk factors such as weight, good and bad cholesterol,
triglycerides and blood pressure. This study suggests that rimonabant can
achieve improvement in blood glucose with the added benefit of significant
weight loss and improvement in other risk factors.”
The results from the trial suggest that Acomplia’s positive effect on
cardiometabolic risk factors come from the product itself and not just
from weight loss, which could prove crucial in the thorny issue of
reimbursement.
Sanofi shares rose as investors greeted the data with enthusiasm, and the study “helps them to say, ‘this is a proper drug, not just an anti-obesity drug’,” according to Nomura Code analyst Paul Diggle, who added that Acomplia did cut blood sugar levels by more than he had estimated, but that its side effects – dizziness, nausea, anxiety, depressed mood and headache – were worse than expected.
Acomplia is a key product for Sanofi, especially as a number of its major
drugs are facing pressure from generics, notably the antithrombotic Plavix
(clopidogrel), Allegra (fexofenadine) for allergies, Amaryl (glimepiride) for diabetes and its oncology agents Eloxatin (oxaliplatin) and Taxotere (docetaxel). Depending on its indications, some observers believe Acomplia could be worth up to $3 billion a year to the firm at its peak.
