Dr. Reddy’s and Rheoscience commences the first Phase III trial of Balaglitazone
Dr Reddy’s Laboratories and Rheoscience A/S, a Danish biopharmaceutical company has announced that the first patient has been dosed in a phase III study with balaglitazone, which is an insulin sensitiser that acts 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.
Balaglitazone is a second generation of PPAR 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. 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 multicentre trial in which type two diabetes patients will be given daily doses of either 10 mg 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 levels – the preferred standard measure of a patient’s blood glucose control over time.
The study is designed to show non-inferiority to actos. As a secondary 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.Balaglitazone is being developed under a co-development agreement between 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. Rheoscience will obtain all necessary regulatory approvals on behalf of Dr Reddy's in the US.