Epidemiologic Surveillance of Glycemic Response to a Scored, Breakable, Extended Release, Fixed Dose Combination of Gliclazide and Metformin in Persons with Type 2 Diabetes.

BACKGROUND The combination of metformin and a sulphonylurea has been recommended for treatment of type 2 diabetes. A, scored, breakable, extended release, once daily fixed dose combination (FDC) of gliclazide and metformin is available in India. OBJECTIVE To assess the initial blood glucose lowering efficacy, glycemic control and patient acceptability of the fixed dose combination of original gliclazide 60mg and metformin 500mg in an extended release, scored and breakable formulation (in a range of 1, 1½, and 2 tablets) among Indian patients in day to day practice. METHODS In a multi-center epidemiologic surveillance protocol of 60 days, patients with type 2 diabetes were prospectively prescribed 1 to 2 tablet of gliclazide 60mg + metformin 500mg during the course of study. The possibility of breaking the tablet in two equal halves enabled administration of 1½ tablets wherever required. Primary data on fasting plasma glucose response and adverse events was extracted for analysis from the case records of patients kept with the investigators. The primary outcome was the proportion of patients achieving glycemic control, defined as fasting plasma glucose of 90-130 mg/dl at the end of the study. RESULTS Of the 759 patients treated with an extended release FDC of gliclazide 60mg + metformin 500mg, the number (%, 95% CI) which achieved glycemic control was 474/759 (62.5%, 59.0% to 65.8%). The proportion controlled with 1 tablet was, 252/759 (33.2%, 29.9% to 36.6%); with 1½ tablets, 149/298, (50.0%, 44.3% to 55.6%); and with 2 tablets, 73/94, (77.5%, 68.2% to 85.0%). Mean (95% CI) FPG mg/dl decreased from baseline by 48.7 (45.0 to 51.4) with 1 tablet; by 71.3 (66.0 to 76.6) with 1½ tablets; and by 86.3 (75.7 to 96.9) with 2 tablets. Frequency of hypo-glycaemia was 0.7%. CONCLUSIONS Extended release FDC of gliclazide 60mg + metformin 500mg, a scored, breakable, once daily, formulation was effective in controlling blood glucose in a large proportion of type 2 diabetes with a low risk of hypoglycaemia.