Dr.ReddyPharma major Dr Reddy’s Laboratories Ltd., (DRL), on Monday, announced results from the first phase III trials of its chemical entity, Balaglitazone, an insulin sensitizer used in the treatment of diabetes.

Dr.ReddyThe 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, oedeman, weight gain and body composition, DRL said in a release.

“These results offer the opportunity for a constructive series of dialogues with both potential partners as well as regulatory agencies. We look forward to workig with Rheoscience to define the path forward for Balaglitazone,” said G V Prasad, Vice Chairman & CEO, DRL.

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, it results in lower body fluid accumulation, lower fat accumulation, less heart enlargement and no reduction of bone.

As per estimates, the number of Type 2 diabetes is expected to reach between 300 and 380 million by 2025.
 
“We are encouraged by these results, which demonstrate the safety and efficacy of Balaglitazone, especially of the 10mg dose in relation to Pioglitazone. We intend to further seek guidance from regulatory agencies on additional studies needed to register Balaglitazone,” said Claus Christiansen, Chairman – Nordic Bioscience.

DRL said, the results of the study will be submitted for presentation in future international scientific meetings and to peer-reviewed journals.