Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian
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ORIGINAL RESEARCH
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 Gian Paolo Fadini
. Carla Giordano . Laura Salvi . Antonio Nicolucci on behalf of The REFLECT Italian Study
Group
Received: July 27, 2020 / Accepted: September 19, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: To evaluate in an Italian realworld 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 The full list of Italian sites participating in this study (contact name, site name, city) can be found in the Electronic Supplementary Material.
Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s13300020-00936-5) contains supplementary material, which is available to authorized users. G. P. Fadini (&) Department of Medicine, University of Padova, Padua, Italy e-mail: [email protected] C. Giordano Section of Endocrinology, Diabetology and Metabolism, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy L. Salvi Novo Nordisk Spa, Rome, Italy A. Nicolucci The Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy
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 A1c (HbA1c) 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. HbA1c 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.
Diabetes Ther
Conclusion: In Italian routine clinical practice, switching from other basal insulins to insulin deglud
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