Initial treatment for uncontrolled type 2 diabetes: A clinical trial comparing basal insulin and modified-release gliclazide.

BACKGROUND: The global rise of type 2 diabetes (T2D) presents significant healthcare challenges in diagnosis, prevention, and treatment. This study compares basal insulin and modified-release gliclazide to assess their effectiveness in managing glycemic control and other clinical factors in T2D patients. METHODS: This open-label, randomized controlled trial included 90 patients with type 2 diabetes mellitus (T2DM) exhibiting poorly controlled glycemic levels (HbA1c > 10%), referred to endocrinology clinic of Imam Khomeini Hospital, Urmia, Iran, between 2023 and 2024. The patients were randomly assigned into one of two intervention groups: the Gliclazide-MR group (n=45), receiving 30 mg of modified-release gliclazide twice daily, or the Basal Insulin group (n=45), receiving basal insulin (detemir or glargine) at a dosage of 0.1--0.3 units per kilogram of body weight. RESULTS: The mean age of participants was 56.4±11.48 years in the gliclazide-MR group and 55.5±13.48 years in the basal insulin group. Baseline demographic characteristics and pre-intervention variables demonstrated no statistically significant differences between the groups (p > 0.05). Both intervention groups exhibited statistically significant reductions in three glycemic indices HbA1c, fasting blood glucose (FBS), and 2-hour postprandial blood glucose (BS2hpp) at the 3-month follow-up compared to baseline (p < 0.001). The gliclazide-MR group demonstrated comparable efficacy to the basal insulin group in reducing these glycemic indices. CONCLUSION: Both basal insulin and modified-release gliclazide demonstrated efficacy in improving glycemic control in patients with severe hyperglycemia. The optimal treatment choice should be individualized based on patient-specific factors and treatment goals.