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Diabetes drug: Dr Reddy’s, Danish co start phase III trials

Our Bureau

Hyderabad, Aug 1 Dr Reddy’s Laboratories and the Danish biopharmaceutical company Rheoscience today announced the commencement of the first phase III trial of Balaglitazone (DRF 2593), a potential drug for diabetes.

Balaglitazone, a novel insulin sensitizer, is being developed under a co-development agreement between the two companies. Rheoscience will retain the marketing rights to the EU and China and Dr Reddy’s will have the marketing rights in the territories of the US and rest of the world.

Rheoscience shall obtain all necessary regulatory approvals on behalf of Dr Reddy’s in the US, according to a joint global announcement by the two companies.

With the first patient administered the drug, the study would be 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 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 over time.

Balaglitazone is a second generation of PPAR (Peroxisome Proliferator-Activated Receptor) gamma agonist with only partial agonistic properties, which in clinical phase II studies have shown to have glucose lowering capabilities and to be body-weight neutral.

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