June 7, 2008 / 5:02 PM / 11 years ago

Sanofi diabetes drug shows promise in study

NEW YORK (Reuters) - An experimental injectable type 2 diabetes drug being developed by Sanofi-Aventis SA was well tolerated and significantly improved blood sugar control compared with a placebo, according to data presented on Saturday.

The 13-week study, presented at the American Diabetes Association scientific meeting in San Francisco, involved 542 patients whose type 2 diabetes was inadequately controlled by metformin — a common diabetes medicine — and tested Sanofi’s AVE0010 in once daily and twice daily regimens.

The once daily treatment demonstrated similar reductions in A1C levels — a key measure of blood sugar — to the twice daily regimen, researchers said. The trial tested the drug at 5, 10, 20 and 30 micrograms against a placebo.

While patients in the study had only mildly elevated baseline A1C levels, the drug demonstrated a highly statistically significant dose response, researchers said.

“The results of the once daily AVE0010 regimen are very promising and this new GLP-1 agonist has a potential to become an important addition to the treatment armamentarium for type 2 diabetes,” Robert Ratner, the study’s lead investigator, said in a statement.

In addition to lowering blood glucose levels, the drug led to modest weight loss, a highly desirable effect in diabetes treatments as obesity is a leading cause of the disease. Some older diabetes medicines cause weight gain.

Patients on the once-daily regimen lost between 2 kilograms (4.4 pounds) at the 5 microgram dose and 3.5 kg (7.7 pounds) at 30 micrograms compared with a loss of 1.9 kg (4.2 pounds) on placebo.

AVE0010 was also associated with reduction in postprandial glucose levels — another measure of blood sugar — in the mid-stage study, researchers said.

Few patients discontinued treatment due to adverse events (1.8 percent to 11.1 percent) on the once daily regimen compared with 1.8 percent on placebo. The most common adverse event was transient dose-dependent nausea.

The French drugmaker last month began an ambitious phase 3 clinical trial program for the drug that is expected to involve more than 3,800 patients.

Phase 3 is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.

Editing by Carol Bishopric

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below