Evaluating Intensive Insulin Therapy With Empagliflozin in Type 2 Diabetes: A Randomised Study

Abstract

Aims/Introduction: Glucotoxicity exacerbates hyperglycemia by impairing insulin secretion and sensitivity, necessitating effective interventions. Although short-term intensive insulin therapy (SIIT) mitigates glucotoxicity, the effect of combining SIIT with sodium-glucose co-transporter 2 (SGLT2) inhibitors in hospitalised type 2 diabetes mellitus (T2DM) patients with severe hyperglycemia remains unclear. Herein, we aimed to evaluate the efficacy and safety of combining SGLT2 inhibitors with basal bolus therapy (BBT) for glycemic control in hospitalised patients with T2DM. Materials and Methods: In this randomised, open-label, single-centre trial, 35 eligible T2DM patients hospitalised for treating hyperglycemia were allocated to the BBT (n = 17) or BBT with empagliflozin (BBT + E) groups (n = 18). Patients were monitored for 7 days using flash glucose monitoring. The primary outcome was time-in-range (TIR, 70–180 mg/dL). The secondary outcomes included time-above-range (TAR), time-below-range (TBR), daily glucose levels, total daily insulin dose and ketone body concentration. Results: The BBT + E group exhibited a significantly higher TIR from day 2, which exceeded 70% by day 5, with reduced TAR and insulin requirements. Blood glucose levels declined more rapidly in the BBT + E group, accompanied by a modest ketone elevation without severe ketoacidosis. The TBR increased marginally on day 7, primarily nocturnally; but no symptomatic hypoglycaemia occurred. Conclusion: The addition of SGLT2 inhibitors to BBT significantly improved early glycaemic control and reduced insulin requirements without severe ketone elevation in hospitalised T2DM patients. Routine monitoring of ketone levels and careful insulin titration are critical to ensure safety.