New Delhi: Dr Reddy’s Laboratories Ltd (DRL), India’s second biggest drug maker, and Denmark’s Rheoscience said their balaglitazone diabetes drug met its primary target of reducing blood glucose levels in clinical trials.
The first of phase 3 clinical trials was conducted on 409 patients over 26 weeks, Hyderabad-based DRL said in a statement to the Bombay Stock Exchange on Monday. The results of the study will be presented to drug regulators, it said.
Balaglitazone belongs to the same family of drugs as Takeda Pharmaceutical Co.’s best-selling diabetes pill Actos, which generated $2.1 billion (Rs9,765 crore) in global sales in the six months ended 30 September. Actos accounted for 26% of Osaka-based Takeda’s revenue.
If successful in bringing balaglitazone to the market, DRL will become the first Indian firm to develop an original drug for diabetes. It will also help DRL lower dependence on revenue from copies of drugs developed by others.
The clinical trial showed that 10mg and 20mg doses of balaglitazone had similar efficacy to 45mg of pioglitazone, the active ingredient in Actos, in reducing glycated haemoglobin and fasting plasma glucose levels, the statement said.