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

Area of Science:

• Endocrinology and Metabolism
• Pharmacology
• Clinical Diabetes Research

Background:

• Glucotoxicity worsens hyperglycemia by impairing insulin secretion and sensitivity in type 2 diabetes mellitus (T2DM).
• Short-term intensive insulin therapy (SIIT) can mitigate glucotoxicity, but its combination with SGLT2 inhibitors for hospitalized T2DM patients with severe hyperglycemia is not well understood.

Purpose of the Study:

• To evaluate the efficacy and safety of combining SGLT2 inhibitors with basal bolus therapy (BBT) for glycemic control in hospitalized T2DM patients.
• To assess the impact on time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), insulin dosage, and ketone body concentration.

Main Methods:

• A randomized, open-label, single-center trial involving 35 hospitalized T2DM patients with hyperglycemia.
• Patients were assigned to either BBT (n=17) or BBT with empagliflozin (BBT+E) (n=18) for 7 days.
• Glycemic control was monitored using flash glucose monitoring, with TIR (70-180 mg/dL) as the primary outcome.

Main Results:

• The BBT+E group showed significantly higher TIR from day 2, exceeding 70% by day 5, with reduced TAR and insulin requirements.
• Blood glucose levels decreased more rapidly in the BBT+E group, with a modest increase in ketone levels but no severe ketoacidosis.
• A marginal increase in TBR was observed, primarily nocturnally, without symptomatic hypoglycemia.

Conclusions:

• Adding SGLT2 inhibitors to BBT significantly enhances early glycemic control and lowers insulin needs in hospitalized T2DM patients.
• The combination therapy demonstrated a favorable safety profile regarding ketone elevation, with no severe ketoacidosis reported.
• Routine monitoring of ketone levels and careful insulin titration are crucial for ensuring patient safety during this combined therapy.