Pharma major Dr Reddy’s Laboratories Ltd. announced results from the first phase III trials of its chemical entity, Balaglitazone, an insulin sensitizer used in the treatment of diabetes.
The company, which conducted the study to determine the efficacy and safety of the drug with Rheoscience — a subsidiary of Nordic Bioscience – said, it met its primary endpoint of reducing HbA1c or Glycoslated haemoglobin’ molecule, which indicates glucose level in blood. Besides, the oral anti- diabetic drug also showed effective results on fasting plasma glucose, weight gain and body composition, DRL said in a release.
DRL, which conducted the trial on 409 patients spread over 26 weeks, said Balaglitazone 10mg, 20mg and Pioglitazone 45mg, showed high efficacy levels. According to DRL, pre-clinical studies showed that Balaglitazone besides robust glucose lowering ability, results in lower body fluid accumulation, lower fat accumulation, less heart enlargement and no reduction of bone formation.
DRL said, the results of the study will be submitted for presentation in future international scientific meetings and to peer-reviewed journals.