Abstract
AIM: To determine whether de-escalating from advanced insulin therapy (AIT) to the combined use of metformin, an SGLT2 inhibitor, a GLP1 receptor agonist and basal insulin is the better option than multiple daily insulin injections (MDI) in obese patients with poorly controlled T2DM. METHODS: This was a 16-week, prospective, randomized, controlled trial. Twenty-two obese patients with T2DM on AIT were randomized to intervention (step-down) or control (MDI) group. In the intervention group, all prandial insulin injections were discontinued, but the patient remained on basal insulin and metformin, to which an SGLT2i and a GLP1 RA were added. In the control group, the patient remained on MDI. RESULTS: Compared to control group (n = 8), A1c was significantly lower at week 4 (9.54% vs 8.25%; p = .0088) and week 16 (9.7% vs 7.31%; p < .001) in intervention group (n = 10). In intervention group, compared to baseline, there was a significant decrease in weight (-16.38 pounds; p = .003), BMI (-3.06; p < .001), LDL cholesterol (-15.7 mg/dl; p = .0378), total cholesterol (-18.5 mg/dl; p = .0386), total daily insulin dose (-57.3 units; p < .001) and a significant improvement in DM-SAT patient satisfaction 0-100 scores: total score (+45.3; p < .001) and subscale scores (Convenience + 35.28, p = .019; Lifestyle + 35.8, p = .0052; Medical control + 51.3, p < .001; Wellbeing + 47.2, p = .0091) at week 16. CONCLUSION: De-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin in obese patients with poorly controlled T2DM on MDI resulted in significant improvement in glycaemic control, weight loss and significantly higher patient satisfaction. This stepping-down approach may be the better option than continuing MDI in these patients.