Rheoscience, Dr. Reddy’s Commence the First Phase III Trial of Balaglitazone

Danish drugmaker Rheoscience and Indian pharmaceutical company Dr. Reddy’s announced that the first patient has been dosed in a Phase III study with Balaglitazone, which is an insulin sensitizer that acts as a partial peroxisome proliferator-activated receptor (PPAR) gamma agonist.

The study is the first in a series of planned Phase III trials that will investigate the safety and efficacy of Balaglitazone (DRF2593-307) as an oral antidiabetic drug, Rheoscience and Dr. Reddy’s said.

In the trial, Balaglitazone will be tested in a six-month, double-blinded, randomized, placebo-controlled, multicenter trial, in which Type 2 diabetes patients will be given daily doses of either 10 or 20 mg of Balaglitazone versus the active comparator Actos (45 mg/day) as an add on to stable insulin treatment, the companies said.

The primary clinical endpoint of the study is a glucose lowering effect assessed as a change in haemoglobin A1c (HbA1c) levels — the preferred standard measure of a patient’s blood glucose control over time, the companies added.

According to the companies, the study is designed to show noninferiority to Actos. As a secondary end point, major emphasis will be focused on assessing the safety profile, including its impact on weight gain and edema, the companies said.

A complete Phase III program has been designed in which the glucose-lowering effects of Balaglitazone will be tested either alone, or in combination with a number of other oral agents, such as metformin and sulfonylurea, the companies said.

Rheoscience said it will retain the marketing rights to European Union and China, and Dr. Reddy’s said it will retain the marketing rights in the territories of U.S. and rest of the world. Rheoscience added that it shall obtain all necessary regulatory approvals on behalf of Dr. Reddy’s in the U.S.