Effects of gliclazide dose escalation on postprandial hyperglycemia in type 2 diabetes mellitus: A prospective, open-label, case-controlled, dose-escalation study

AbstractObjectives: The aims of this study were to determine the effects of increasing doses of gliclazide on postprandial glucose excursions after a standardized breakfast and lunch, and to clarify the relationship between gliclazide dose and glucose response.Methods: This prospective, open-label, case-controlled, dose-escalation study was conducted at the Addington Hospital Diabetes Clinic, eThekwini/Durban, KwaZulu-Natal, South Africa. Male and female patients aged ≥18 years with type 2 diabetes mellitus (DM) and postprandial hyperglycemia (2-hour postprandial blood glucose [PPBG2 h] level, ≥11.1 mmol/L [≥200 mg/dL]) and receiving an oral hypoglycemic agent were eligible. After a 1-week washout period during which patients were asked to discontinue treatment with all oral hypoglycemic agents, baseline glycemic measurements were performed (fasting blood glucose, PPBG2 h, 6-hour postprandial blood glucose [PPBG6 h], mean blood glucose [MBG], plasma insulin, fasting serum fructosamine, and glycosylated hemoglobin). All patients subsequently received 2 weeks of oral treatment with each of 3 doses of gliclazide: 40, 80, and 160 mg/d. Glycemic parameters were measured at the end of each dosing interval. Adverse-effect monitoring included direct reporting of untoward effects to the resident medical practitioner, clinical examination, monitoring of home blood glucose records, hematology, and liver and kidney function tests. Compliance was assessed using pill counts, examination of diary entries, and patient interview.Results: Thirty-three patients were screened; 14 entered the dose-escalation phase. Thirteen patients completed the study (7 women, 6 men; mean [SD] age, 52.0 [11.1] years); 1 was withdrawn because of poor compliance. Dose escalation from 40 to 80 mg/d was associated with a significant change only in MBG (mean [SD], 11.3 [4.2] vs 10.0 [3.9] mmol/L [203.6 (75.7) vs 180.1 (70.3) mg/dL]; P