Dr Reddy's and Rheoscience commence Phase III diabetes drug trials
By Our Corporate Bureau | 02 Aug 2007
Mumbai: Dr Reddy's Laboratories Ltd and Rheoscience A/S, a Danish biopharmaceutical company, have started joint Phase III trials of Balaglitazone (DRF2593-307), an insulin sensitizer that acts as a partial PPAR (peroxisome proliferator-activated receptor) gamma agonist.
The first patient has been dosed in a study with Balaglitazone on July 31. 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, the company said in a filing with the Bombay Stock Exchange (BSE).
Balaglitazone is a second generation PPAR gamma agonist with only partial agonistic properties, which in clinical phase II studies have shown to have glucose lowering capabilities and is body-weight neutral. In preclinical experiments, Balaglitazone has been shown to cause less fluid retention than full PPAR gamma agonists, the company stated in its filing.
The drug will be tested in a 6-month double-blinded, randomised, placebo-controlled multi-centre 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 primary clinical end-point 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 overtime.
The study is designed to show non-inferiority to Actos. As a secondary end paint, 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 company said.
Dr Reddy's is developing Balaglitazone under a co-development agreement with Rheoscience. The latter will retain the marketing rights to the European Union and China and DRL will retain the marketing rights for the United States and rest of the world.
Rheoscience will obtain all necessary regulatory approvals on behalf of the company in the United States, the statement added.
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