Dr. Reddy’s Laboratories Ltd. (NYSE:RDY) and Rheoscience, a subsidiary
of Nordic Bioscience A/S, today announced the headline results from the
first phase III study for their investigational agent, Balaglitazone.
The study (Study 307) was a phase III, randomized, double blind,
parallel-group placebo- and active comparator-controlled clinical study
to determine the efficacy and safety of balaglitazone. The study
showed that the trial met its primary endpoint of reduction in HbA1c.
“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”
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. The primary
endpoint was HbA1c reduction, while several secondary endpoints
including fasting plasma glucose, oedema, weight gain, and body
composition were considered.
In all, 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.