Efficacy and Safety of Plus a Sulfonylurea
A 20–23-week, double-blind study was conducted to determine the efficacy and tolerability of the combination of pioglitazone and a in the treatment of poorly controlled (HbA1c >8.0%) in patients who had been on a stable dose of a for at least one month. Patients were randomized to treatment with their usual treatment plus once-daily 15 mg (n=184), pioglitazone 30 mg (n=189), or placebo (n=187).
Patients who received pioglitazone plus a had significant decreases from baseline (P<0.05) in HbA1c and fasting glucose levels compared with those who received placebo plus a sulfonylurea. Compared with placebo, patients treated with 15 mg had a mean decrease of HbA1c of 0.9% (95% CI: 0.06% to 1.2%) and those treated with pioglitazone 30 mg had a mean decrease of of 1.3% (95% CI: 1% to 1.6%). Both groups had significant (P<0.05) decreases in triglyceride levels and increases in levels compared with the placebo group. was well tolerated. The adverse events rates were similar in all groups.
It was concluded that pioglitazone plus a significantly improves HbA1c and fasting glucose levels and has beneficial effects on and triglyceride levels.
Kipnes MS, Krosnick A, Rendell MS, et al. hydrochloride in combination with therapy improves glycemic control in patients with mellitus: a randomized, placebo-controlled study. Am J Med. 2001;111:10-17.
The above summary is adapted from the cited reference.