Dr Reddys 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
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 prechnical experiments, balaglitazone
has been shown to cause less fluid retention than full
PPAR gamma agonists, the company stated in its filing.
drug will be tested in a 6-month double-blinded, randomised,
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 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.
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.
Reddy''s is developing Balaglitazone under a co-development
agreement with Rheoscience. The latter will retain the
marketing rights to European Union and China and DRL will
retain the marketing rights for the United States and
rest of the world.
Rheoscience shall obtain all necessary regulatory approvals
on behalf of the company in the United States, the statement