Real-world experience of treatment individualization based on fixed-dose combination of gliclazide extended release+ metformin extended release in type 2 diabetes mellitus

Objective To evaluate efficacy of gliclazide extended release (XR) 60 mg + metformin XR 500 mg fixed-dose combination (FDC) with metformin as add-on (as needed) in real-world clinical practice. Methods This prospective observational study was performed in patients with type 2 diabetes mellitus uncontrolled on metformin (group M) or on conventional gliclazide XR 60 mg + metformin XR 500 mg (group GM); and newly diagnosed or untreated patients with HbA1c >9% (group U) at 6 out-patient diabetes care units. Patients received gliclazide XR 60 mg + metformin XR 500 mg FDC and metformin (as needed) at baseline for 30 days. Up-titration with gliclazide capped at 120 mg and metformin every 30 days till day-90. Proportion of patients achieving target FPG was primary endpoint. Results Of 455 patients (mean age:51.9±11.3 years; mean BMI 26.7±6.2 kg/m2), 261 patients had family history of diabetes and 161 patients had hypertension. Target FPG was achieved with 1 tablet each of gliclazide XR 60 mg + metformin XR 500 mg FDC and metformin by 73.09%, 74.26%, and 60.66% patients in groups M, GM, and U, respectively. Only 29.23% patients required up-titration to 1 tablet of FDC + 2 tablets each of metformin and FDC at days 60 and 90. Mean FPG, PPG and HbA1c significantly reduced at day-90 (P<0.001). Conclusions It can be concluded from this real-world primary-care practice study that the use of gliclazide XR 60 mg + metformin XR 500 mg FDC and metformin (as needed) was effective and well tolerated, and >3 out-of 5 patients achieved target glycemic control within 30 days in all groups.