Anti-Diabetes Pill Balaglitazone on Track for Approval, Offers Less Weight Gain than Other Treatments

The experimental diabetes drug balaglitazone, under development by Dr. Reddy’s Laboratories, has hit its primary target in recent late-stage clinical trials, successfully lowering blood glucose levels in patients with type 2 diabetes, with less weight gain and water retention than seen with pioglitazone (Actos) treatment.

Researchers announced on January 4, 2010, that the drug met its primary endpoint of lowering blood sugar with few adverse events. The 26-week clinical trial tested 10 mg and 20 mg doses of balaglitazone against 45 mg pioglitazone (Actos), a widely-used, once-daily medication that helps to control blood sugar in people with type 2 diabetes. The Phase III trials with balaglitazone showed that the 10 mg dose of the drug had less impact on weight and less water retention than Actos. Additionally, balaglitazone showed less fat accumulation, less bone loss, and less heart enlargement.

“We are encouraged by these results, which demonstrate the safety and efficacy of balaglitazone, especially of the 10 mg dose in relation to pioglitazone,” said G.V. Prasad, Vice Chairman and CEO of Dr. Reddy’s Laboratories, India’s second largest pharmaceutical company. “We intend to further seek guidance from regulatory agencies on additional studies needed to register balaglitazone.”

Balaglitazone is under development as a partial PPAR (peroxisome proliferator-activated receptor)-gamma agonist, believed to have a better safety profile than full PPAR-gamma agonists like pioglitazone (Actos) and rosiglitazone (Avandia). In 2007, the Food and Drug Administration (FDA) issued Black Box warnings for Actos and Avandia concerning the cardiac risks associated with the drugs. Both have been linked to congestive heart failure, fluid retention, and heart enlargement.

Researchers report that balaglitazone is on track for regulatory approval by the FDA.