Objective: To evaluate the efficacy and safety profile of a slow-released-gliclazide (Diamicron MR) in type 2 diabetes patients.
Methods: 159 patients with type 2 diabetes were parallelly assigned to a slow-released-gliclazide or gliclazide group in a randomized, open, multi-center phase III study to compare the efficacy of slow-released-gliclazide and gliclazide on overall diabetes control through HbA1c and the adverse events including hypoglycemic episodes and change of vital signs, electrocardiogram and clinical laboratory parameters after a 12-week treatment period.
Results: No statistically significant difference was found in HbA1c levels between the slow-released-gliclazide and the gliclazide group (P = 0.66) after 12 weeks of treatment. HbA1c levels in the slow-released-gliclazide group were extremely close to those in the gliclazide group after 12 weeks of treatment (95% CI -0.15; +0.24%). Furthermore, plasma glucose area under curve/24 hours, mean daily plasma glucose and fasting serum insulin levels between these two groups were also not statistically different, indicating that the efficacy of treatment was similar. The number of patients reported to experience at least one episode of hypoglycemia, which was confirmed by capillary or venous glucose assessment, but by no means severe, was similar in both the treatment groups. The main reason for the hypoglycemic episodes was related to good plasma glucose control. No adverse event led to withdrawal of the medication. Systolic and diastolic blood pressure, heart rate and body weight did not change during the study. There was also no noticeable change in electrocardiogram, lipid profile, and parameters in blood biochemistry and hematologic testing during the study.
Conclusion: Slow-released-gliclazide and gliclazide had a similar efficacy and safety profile.