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Sanofi Anti-Obesity Drug May Help Diabetes Patients
Posted on 2006-12-05 08:35:00
Sanofi-Aventis's Acomplia pill can significantly improve blood sugar levels in patients with type 2 diabetes while also reducing their weight, clinical trial data sponsored by the French drug manufacturer showed.
It was Sanofi’s first non-obesity trial with the treatment, which it has touted as a potential $3 billion annual seller. Acomplia, or rimonabant, is being prescribed as an anti-obesity drug in several countries but is still awaiting U.S. marketing approval.
The six-month study involved 278 patients with type 2 diabetes who were not taking any diabetic drugs. In this most common form of the disease, chiefly linked to obesity, the body can't regulate the insulin hormone the body needs to use sugar.
Sanofi's so-called Serenade trial showed that HbA1c blood sugar levels in patients on a once-daily 20 mg Acomplia pill fell 0.8 percentage points from their baseline value of 7.9 percent against a drop of 0.3 points in those taking a placebo.
More significantly, Sanofi said, patients with a blood sugar level of at least 8.5 percent at baseline saw their blood sugar level decrease 1.9 percentage points when taking Acomplia compared with 0.7 points in patients on a placebo.
“It is extraordinary that in this last group––about 25% of the participants––rimonabant was as efficient as several of the best anti-diabetic treatments,” said Marc Cluzel, the company’s head of international development scientific and medical affairs.
The blood sugar level in more than half of the patients on Acomplia fell to below 7%––the target that the American Diabetes Association sees as good glucose control––and they lost 15 pounds of their weight, compared to 6 pounds among those on a placebo. Many diabetic drugs lead to weight gains.
In addition, patients’ waist circumference, which measures abdominal obesity, shrank 2.4 inches if they were on Acomplia, while those on a placebo saw their waists shrink 1 inch, the trial showed. Furthermore, those on Acomplia benefited from improved good HDL cholesterol and cut bad fat levels in the blood.
In several European countries Acomplia is approved for use along with diet and exercise to treat people who are obese or overweight and who also have diabetes or high cholesterol. In Mexico it may also be prescribed as a complement to other anti-diabetics to improve blood sugar.
The outcome of the randomized Serenade trial, conducted in seven countries among females and males of at least 18 years, was presented at the International Diabetes Federation (IDF) World Diabetes Congress in Cape Town.
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