Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study.

Introduction: To evaluate in an Italian real-world setting the safety and effectiveness of insulin degludec 100 units/mL, given once daily in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) after switching from other basal insulins.

Methods: ReFLeCT was a multicenter, prospective, observational study conducted across seven European countries which involved adult patients whose physician planned to switch their medication from basal insulin to insulin degludec. The primary outcome was the change in the number of hypoglycemic episodes before and after the switch to insulin degludec. Results are expressed as 12-month follow-up/baseline incidence rate ratios (IRRs) with 95% confidence intervals (95% CIs).

Results: The Italian cohort of the ReFLect study comprised 148 patients with T1DM and 311 patients with T2DM. In patients with T1DM, the switch to insulin degludec was associated with significantly lower rates of overall (IRR 0.69, 95% CI 0.57-0.82), non-severe (IRR 0.72, 95% CI 0.60-0.85), and nocturnal hypoglycemia (IRR 0.46, 95% CI 0.31-0.69). Following the switch, hemoglobin A (HbA) levels decreased significantly by 0.35% (95% CI - 0.50 to  - 0.20), with no significant changes in fasting plasma glucose (FPG) and basal insulin dose. Body weight increased by 0.83 kg (95% CI 0.16-1.50). In patients with T2DM, significant reductions in the rates of overall (IRR 0.40, 95% CI 0.29-0.55), non-severe (IRR 0.47, 95% CI 0.34-0.63), and nocturnal hypoglycemia (IRR 0.27, 95% CI 0.09-0.86) were documented. HbA and FPG decreased significantly by 0.45% (95% CI - 0.58 to - 0.31) and 0.90 mmol/L (95% CI - 1.21 to - 0.59], respectively, with no significant changes in basal insulin dose or body weight. Treatment satisfaction significantly improved in both diabetes types.

Conclusion: In Italian routine clinical practice, switching from other basal insulins to insulin degludec reduced the total episodes of hypoglycemia and improved glycemic control and treatment satisfaction in patients with T1DM and T2DM.

Trial Registration: ClinicalTrials.gov NCT02392117.