Effects of Short-Term Intensive Insulin Therapy Combined With Oral Hypoglycemic Agents for Inducing Remission in Newly Diagnosed Type 2 Diabetes Mellitus: A Randomized Clinical Trial.

AIMS: To investigate the effects of combining oral hypoglycemic agents with short-term intensive insulin therapy (SIIT) via continuous subcutaneous insulin infusion (CSII) on glycemic outcomes in adults with newly diagnosed type 2 diabetes mellitus. MATERIALS AND METHODS: In this multicenter, open-label trial, 245 participants were randomized to three treatment arms: SIIT for 2 weeks (CSII group), SIIT plus 90-day metformin and pioglitazone (CSII + Met + Pio group), or SIIT plus 90-day sitagliptin (CSII + Sita group). The primary outcome was the 12-month diabetes remission rate. Parameters of glycemic control, β-cell function, and insulin resistance were compared among groups. RESULTS: The participants had a mean HbA1c of 10.6% ± 2.2%. Compared to the CSII group, both combination groups had lower total daily and pre-meal bolus insulin requirements with higher time in tight target range (TITR) during SIIT, and had significantly greater acute insulin response (AIR) after SIIT. Three months post SIIT, more participants in the CSII + Met + Pio group (78.7%, 59/75) achieved HbA1c < 6.5% compared with the CSII group (59.0%, 46/78; adjusted p < 0.05), but the 12-month diabetes remission rates were similar (p = 0.972). CONCLUSIONS: Oral hypoglycemic agents facilitated SIIT implementation and enhanced transient improvements in glycemic control. However, similar 12-month diabetes remission rates suggest prolonged sequential therapy may be needed for sustained glycemic benefit.