Balaglitazone cuts down HbA1c levels in clinical studies: Dr Reddy’s & Rheoscience

Balaglitazone (DRF 2593), an investigative drug to treat diabetes cuts down HbA1c levels significantly, according to Dr. Reddy’s and Rheoscience, the developers of the drug.

Balaglitazone results from first phase III clinical trial of has shown that it can significantly reduce in HbA1c wand improve safety profile.

The phase III balaglitazone study was a randomized, double blind, parallel-group placebo- and active comparator-controlled clinical study to determine the efficacy and safety of balaglitazone.

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.

409 patients were randomized in roughly equal proportions across the four arms of the study.

All three active arms (balaglitazone 10mg, 20mg and pioglitazone 45mg) showed similar levels of efficacy with respect to both HbA1c and fasting plasma glucose.

Balaglitazone has also showed good tolerability and adverse event profile, with balaglitazone 10mg demonstrating less water retention, less fat accumulation, lower weight/BMI gain and less bone loss when compared to the pioglitazone arm.

“These results offer the opportunity for a constructive series of dialogues with both potential partners as well as regulatory agencies. We look forward to working with Rheoscience to define the path forward for Balaglitazone”, said GV Prasad, vice chairman & CEO, Dr. Reddy’s.

Balaglitazone is a novel partial agonist of PPAR-gamma, which elicits only 52% of the PPAR-gamma activation observed with both pio- and rosiglitazone.

Pre-clinical studies have indicated that besides robust glucose lowering ability, balaglitazone results in lower body fluid accumulation, lower fat accumulation, less heart enlargement and no reduction of bone formation, indicating that Balaglitazone may be able to displace the balance between desired and side effects, and thus show a better safety profile than full agonists of PPAR-gamma.

Type 2 diabetes is a major cause of morbidity and mortality in the industrialized world, with cardiovascular disease as the leading cause of death, accounting for almost 50% of all type 2 diabetes deaths.

The number of type 2 diabetes patients is increasing rapidly, and the number of patients is expected to reach between 300 and 380 million by 2025, thereby placing an enormous economical burden on global healthcare.

Dr. Reddy’s Laboratories has three core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Our products are marketed globally, with a focus on India, US, UK, Germany and Russia.

Rheoscience is a Danish biopharmaceutical company focused on the discovery and development of novel pharmaceutical products for the treatment of metabolic diseases such as diabetes and obesity.