Efficacy and safety of gliclazide in the treatment of non-insulin-dependent diabetes mellitus: a Canadian multicenter study
Mailhot, J.
Clinical Therapeutics 15(6): 1060-1068
1993
ISSN/ISBN: 0149-2918 PMID: 8111803 Document Number: 419201
A postmarketing study involving 114 office practices provides the largest body of clinical experience to date in Canada with the second-generation sulfonylurea gliclazide in the treatment of non-insulin-dependent diabetes mellitus (NIDDM). This study focused on efficacy and safety in 411 NIDDM patients. Subjects included patients whose disease was not controlled by diet alone or by diet plus an antidiabetic drug. The dose of gliclazide was 80 mg/day to 320 mg/day. Patients were treated for 3 months, with monthly evaluations. Fasting and 2-hour blood glucose and glycated hemoglobin levels were measured before and after the study period, with all values showing a significant decrease (P = 0.01). Total cholesterol and triglyceride levels also decreased significantly during the study (P = 0.05). Adverse effects were recorded in 30 (7.3%) of patients and led to the withdrawal of 1.2% from the study. Hypoglycemia symptoms were less frequently encountered with gliclazide than with previous treatments (P = 0.001). Gliclazide was found to be safe and well tolerated in the majority of patients. The results of this study appear to confirm the established efficacy of gliclazide in treating NIDDM.