Pharmaceutical and therapeutic equivalence study of the generic drug containing gliclazide

Objectives: The use of generic drugs is recommended for reducing of medical costs. However, many doctors and pharmacists do not trust the quality, efficacy and safety of some generic drugs. Glimicron® containing gliclazide is widely used for the treatment of diabetes mellitus, and glimiran® is the generic drug of glimicron®. Then, the pharmaceutical and therapeutic equivalence of glimiran® was compared to glimicron®. Methods: The elution rate of gliclazide from glimiran® was compared to that of glimicron®. In addition, clinical data of the patients treated with glimiran® in Fukuoka Memorial Hospital was compared to those treated with glimicron® in Fukuoka University Chikushi Hospital. The number of patients treated with glimiran® and glimicron® was 28 and 56, and the mean age was 63.9 years old and 60.3 years old, respectively. Results: One of two lots of glimiran® did not satisfy the standards of elution of gliclazide. However, the effect of glimiran® on both blood sugar and hemoglobin A1c after 8-12 weeks was equivalent to glimicron®. In addition, in a manner similar to that of glimicron®, glimiran® did not induce hematopoietic injury, hepatic dysfunction or renal dysfunction during the period from 8-12 weeks after the initiation of treatment. Conclusions: Although glimiran® is not 100% pharmaceutically equivalent to glimicron®, the efficacy and safety are considered to be equivalent to glimicron®.