Dr Reddy's starts human drug trials on diabetes drug

Chennai, Aug 1 (UNI) Dr Reddy's Laboratories and Rheoscience A/S today announced the first patient had been dosed in a Phase III study with Balaglitazone, an insulin sensitizer acting as a partial PPAR (peroxisome proliferator-activated receptor) gamma agonist.

The study is the first in a series of planned Phase III trials which will investigate the safety and efficacy of Balaglitazone as an oral anti-diabetic drug, a company release here said.

Balaglitazone was a second generation of PPAR gamma agonist with only partial agonistic properties, which in clinical phase II studies had shown to have glucose lowering capabilities and be body-weight neutral.

In preclinical experiments, balaglitazone has been shown to cause less fluid retention than full PPAR gamma agonists.

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

The primary clinical end-point of the study was 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 study was designed to show non-inferiority to Actos.

As asecondary end point, major emphasis will be focused on assessing the safety profile, including its impact on weight gain and oedema.

A complete Phase III programme 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 release added.

Balaglitazone was being developed under a co-development agreement between India based Dr. Reddy's and Rheoscience in Denmark.

Rheoscience will retain the marketing rights to European Union and China and Dr. Reddy's will retain the marketing rights in the territories of United States and rest of the world.

UNI