[Comparison of the effect and tolerability of two glibenclamide preparations with different release rates].
In a double-blind, randomized, multicenter, two-way crossover study, efficacy and tolerability of two glibenclamide (CAS 1028-21-8) preparations with different rates of release were compared during a 28 day long-term treatment period for each preparation. It involved 80 patients with diabetes mellitus type II difficult to stabilize orally, who had received preliminary glibenclamide treatment. The switching from one treatment to the other in particular was strictly controlled: day profiles on glucose and insulin were prepared on the last day of the long-term therapy period and again on the first two days of the next long-term therapy period. Halfway through each treatment period and on the last day of each therapy period, the glucose content of the 24 h urine was determined in order to assess diabetes stabilization. The quality of diabetes stabilization and tolerability being comparable for both treatments, there were no statistically significant differences determined for AUC, Cmin, Cmax, tmin and tmax in the insulin day profile and glucose day profile on switching from treatment A (Glibenclamid-ratiopharm) to B (reference preparation) nor from B to A. The tolerability of both preparations was very good.
Schlich
D
D
Arztlicher Arbeitskreis für Praxismethodik e.V., Frankfurt/Main.
Lichtenberger
K
K
Klingmann
I
I
Pabst
G
G
Jaeger
H
H
D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005905:Glyburide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006443:Hemoglobin A2 / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000097:blood; D008297:Male; D008875:Middle Aged
D001786:Blood Glucose; D007328:Insulin; D006443:Hemoglobin A2; D005905:Glyburide
Vergleich der Wirksamkeit und Verträglichkeit zweier verschieden schnell freisetzender Glibenclamid-Zubereitungen.