A double-blind comparison of two glibenclamide preparations, HB 419 and HB 420, in maturity-onset (type 2) diabetic patients.
A double-blind cross-over study was performed to compare the efficacy in maturity-onset (type 2) diabetes of two glibenclamide preparations, HB 419, currently in general use, and HB 420, a new product with more complete absorption. Nineteen diabetic outpatients participated in the study. Seventeen completed the trial. Before the trial, fasting blood glucose levels in all patients were over 7.0 mmol/l, relative body weights were below 130% and daily glibenclamide doses ranged from 10 to 15 mg. The study was made up of two periods, each lasting for two months. The trial dosage of HB 419 was 5 mg twice a day and of HB 420 3.5 mg twice a day. Fasting blood glucose levels, diurnal glucose excretion, glycohaemoglobin A1 (GHbA1) levels, body weight and blood pressure levels were determined. The mean (+/- SEM) fasting blood glucose concentration was 11.5 +/- 0.6 mmol/l at the end of the baseline period. After one month of treatment, the mean fasting blood glucose level was 11.4 +/- 0.6 mmol/l in patients on HB 419 and 12.5 +/- 0.7 mmol/l in patients on HB 420 (p less than 0.01) but at the end of the two treatment periods the mean fasting blood glucose value was the same (11.6 +/- 0.5 mmol/l) for both glibenclamide preparations. No significant differences were found in GHbA1 values, diurnal glucose excretion, body weight or blood pressure levels between the treatment regimens.
D000368:Aged; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005905:Glyburide / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged
D005905:Glyburide