India-based drug maker Dr. Reddy's Laboratories and a subsidiary of Nordic Bioscience, Rheoscience, announced the success of a diabetic compound from the first phase III study. According to the study, their investigational agent, Balaglitazone, a diabetes compound was successful in the trial, meeting the study's primary endpoint of reduction in HbA1c.
The study was a randomized, double blind, parallel-group placebo- and active comparator-controlled clinical study to determine how effective and safe the diabetic compound Balaglitazone was, in usage. The study explored the impact of adding placebo, Balaglitazone 10mg, Balaglitazone 20mg or Pioglitazone 45mg to a background treatment regimen of stable insulin therapy for a period of 26 weeks. While the primary endpoint was HbA1c reduction, there were various secondary endpoints including fasting plasma glucose, edema, weight gain, and body composition.
The study had 409 patients randomized in roughly equal proportions across the four arms of the study. All three active arms (Balaglitazone 10mg, 20mg and Pioglitazone 45mg) showed levels of efficacy that were alike for HbA1c and fasting plasma glucose.
All three active arms demonstrated good tolerability and adverse event profile, with Balaglitazone 10mg showing less water retention, less fat accumulation, lower weight/BMI gain and less bone loss in comparison to the Pioglitazone arm. Adverse events were similar in number across the three active arms, with adverse events of special interest such as bone fracture, hematuria, heart failure, cardiac ischemia, oedema, weight gain, being less in number in the Balaglitazone 10mg group compared to Pioglitazone 45mg.
According to Mr GV Prasad, Vice Chairman and CEO, Dr. Reddy's, "These results offer the opportunity for a constructive series of dialogues with both potential partners as well as regulatory agencies." He added, "We look forward to working with Rheoscience to define the path forward for Balaglitazone."
Dr Claus Christiansen, Chairman of Nordic Bioscience said of the successful results, "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."