Treatment of Type 2 Diabetes with a Breakable Extended Release Gliclazide Formulation in Primary Care: The Xrise Study.

OBJECTIVE:This study examines whether a new, scored and breakable once daily gliclazide tablet formulation, gliclazide XR 60 mg, that enables a simple 2-steps titration, can improve glycemic control rates in the community. METHODS:In a prospective multicenter study of 4 months duration, organised in the primary care setting of urban India, type 2 diabetes patients, uncontrolled with diet alone or metformin monotherapy, received 1 (60 mg), 1½ (90 mg), or 2 (120 mg) tablets of gliclazide XR 60 mg to achieve a target fasting plasma glucose of 126 mg/dl, or HbA1c of 7%. The primary outcome was the frequency of patients achieving glycemic control. RESULTS:Two hundred eleven investigators recruited 679 patients distributed throughout India. On intention to treat analysis, the number (%, 95% confidence interval, CI) of patients achieving glycemic control was, 526 (81.9, 78.8 to 84.6); with gliclazide XR 60 mg 1 tablet, 285 (42.0, 38.3 to 45.7); 1½ tablets, 143 (21.1, 18.2 to 24.3); and 2 tablets, 98 (14.4, 12.0 to 17.3). Hypoglycaemic episodes were reported by 27 (4.0, 2.8 to 5.7) patients. Mean (95% CI) FPG decreased by 78.3 (73.9 to 82.7, P < 0.01) mg/dl; with 1 tablet gliclazide XR 60 mg, by 66.0 (61.1 to 70.9, P < 0.01) mg/dl; 1-½ tablets, by 80.1 (71.2 to 88.5, P < 0.01) mg/dl; and 2 tablets, by 106.5 (93.4 to 119.5, P< 0.01) mg/dl. HbA1c decreased by 1.5 (1.3 to 1.5, P < 0.01). CONCLUSIONS:In primary care, once daily, breakable extended release gliclazide XR 60 mg, with a simple two step titration to administer maximum recommended dosage is effective in achieving short term glycemic control with a low frequency of hypoglycaemia, in monotherapy or in combination with metformin.