Efficacy and safety of the partial PPARgamma agonist balaglitazone compared with pioglitazone and placebo: A phase III, randomised, parallel-group study in patients with type 2 diabetes on stable insulin therapy
Diabetes/Metabolism Research and Reviews, 03/01/2011
Henriksen K et al. – In the balaglitazone 10mg treated group clinically relevant reductions in HbA1c and glucose levels were observed, although it appeared to be a little less potent that pioglitazone 45mg.Methods
- 409 subjects from 3 countries with type 2 diabetes on stable insulin therapy were randomised to 26 weeks of double–blind treatment with once daily doses of 10 or 20mg balaglitazone, 45 mg pioglitazone, or matching placebo (n>=99 in each group).
- The primary endpoint was the efficacy of balaglitazone 10mg and 20mg versus placebo on the absolute change in HbA1c.
- Secondary endpoints included levels of fasting serum glucose (FSG), and changes in body composition and bone mineral density as measured by DXA, with comparison to pioglitazone 45mg.
- In the 10 and 20mg balaglitazone groups, and in the pioglitazone 45mg group, significant reductions in HbA1c levels were observed (–0.99%, –1.11% and –1.22%) versus placebo.
- FSG was similarly reduced in all treatment arms.
- DXA analyses showed balaglitazone 10mg led to less fat and fluid accumulation and no change in bone mineral density, when compared to pioglitazone.