Treatment of Type 2 Diabetes with Gliclazide Modified Release 60mg in the Primary Care Setting of India

Abstract

The majority of Indian type 2 diabetic patients are treated in the primary care setting, and not more than one quarter attain recommended glycemic control targets. This study examines whether substituting twice daily gliclazide 80mg with once daily gliclazide modified release (MR) 60mg achieves better control of type 2 diabetes in the primary care setting. In a prospective multicentre study, medication with twice daily gliclazide 80mg in the treatment regimen of uncontrolled type 2 diabetic patients was substituted with once daily gliclazide MR 60mg, without changing any other antidiabetic drugs or their doses for 14 weeks. The primary outcome was the number of patients achieving glycemic control. 101 investigators recruited 162 patients distributed throughout India. On intention to treat analysis, 64.8% (57.4 to 72.2%) of patients achieved fasting blood glucose of less than 130 mg/dl, and there were 4.3% fewer hypoglycaemic episodes. Mean (95% confidence interval) fasting plasma glucose decreased by 73.3 (69.5 to 87.1, P< 0.01) mg/dl, total cholesterol by 20.2 (13.4 to 27.0, P< 0.01) mg/dl; low density lipoprotein cholesterol by 13.2 (7.8 to 18.6, P< 0.01) mg/dl; and total triglycerides by 21.5 (10.7 to 32.3, P< 0.01) mg/dl. Mean compliance was 96.9% with gliclazide MR 60mg. Once daily gliclazide MR 60mg is more effective than twice daily gliclazide 80mg in glycemic control and causes less hypoglycemia, both in monotherapy and in combination with other agents. Gliclazide MR is a useful once daily sulphonylurea formulation for the management of type 2 diabetes in primary care.