Noninferiority Effects on Glycemic Control and β-Cell Function Improvement in Newly Diagnosed Type 2 Diabetes Patients: Basal Insulin Monotherapy Versus Continuous Subcutaneous Insulin Infusion Treatment

Aims: In newly diagnosed type 2 diabetes mellitus (T2DM) patients, short-term insulin therapy might improve beta-cell function and glycemic control. This study aimed to compare the effects of basal insulin monotherapy with continuous subcutaneous insulin infusion (CSII) treatment. Methods: Fifty-nine cases of newly diagnosed T2DM patients with fasting plasma glucose of 9.0-16.7 mmol/L were recruited into this study. They were hospitalized and randomly assigned to a basal insulin monotherapy group (n = 27) or a CSII group (n = 32). Insulin dosage was titrated according to fasting capillary blood glucose levels, and treatment was stopped after 2 weeks. Intravenous glucose tolerance tests were performed, and blood glucose, insulin, C-peptide, and lipid profiles were measured before therapy and 2 days after therapy withdrawal. Results: Both treatments reduced fasting and postprandial blood glucose levels (after treatment vs. baseline, both P < 0.05). Fasting glycemic control target was achieved in 52 cases (88.14%) with 2 weeks of insulin treatment, and there were no significant differences between the glargine and CSII groups (P = 0.059). The time to achieve fasting glycemic target in the CSII group was shorter than that in the glargine group (P < 0.01). Plasma lipid profiles such as triglycerides and total cholesterol also decreased significantly after the intervention. Overall b-cell function improved significantly after insulin intervention (P < 0.01). Variation did not differ between two groups, nor did the effects on insulin and C-peptide secretion (P > 0.05). Conclusions: The effect of basal insulin monotherapy was similar to that of CSII, and thus basal insulin monotherapy might be a reasonable alternative to CSII for initial insulin therapy in newly diagnosed T2DM patients.