Background and aims: Data on second generation basal insulin (2BI) in people with type 2 diabetes (T2D) generated by clinical trials still need confirmation in real-world clinical set-tings. This study aimed at assessing the comparative effectiveness of 2BI [Glargine 300 U/mL (Gla-30 0) vs. Degludec 100 U/mL (Deg-10 0)] in T2D Italian patients switching from first gener-ation basal insulins (1BI).Methods and results: This was a retrospective, non-inferiority, multicenter study. Patients switch-ing to Gla-30 0 or Deg-10 0 from 1BI were 1:1 propensity score matched (PSM). Changes during 6 months in continuous endpoints were assessed through linear mixed models. Incidence rates (IR) of hypoglycemia (episodes per patient-months) were compared using Poisson regression.Each PSM cohort included 593 patients. HbA1c decreased from baseline (8.7%) to 6 months by-0.58% (95%CI-0.69;-0.47) in Gla-30 0 group and-0.50% (95%CI-0.61;-0.39) in Deg-10 0 group, confirming the non-inferiority of Gla-30 0 vs. Deg-100. No between-group differences emerged: FBG was reduced by about 20 mg/dl with both 2BI, mean dose of 2BI (24.5 U, 0.3 U/Kg at the first prescription) was suboptimally titrated during 6 months (+1.34 U in Gla-30 0 and + 1.76 U in Deg-10 0), body weight showed minor changes.IR of hypoglycemia <54 mg/dl was 0.32 (95%CI 0.21; 0.49) in Gla-30 0 group and 0.19 (95%CI 0.11; 0.33) in Deg-10 0 group (p Z 0.14). Conclusion: In subjects with T2D, switching to 2BI from 1BI was associated with similar improve-ments in glycemic control, low hypoglycemia rates and no weight gain in real-life setting. Clinical inertia, represented by late treatment intensification and suboptimal titration, represents a major issue in Italy. 2022 The Author(s). Published by Elsevier B.V. on behalf of The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Buzzetti, R., Fadini, G.P., Nicolucci, A., Larosa, M., Rossi, M.C., Cucinotta, D. (2022). Comparative effectiveness of Glargine 300 U/mL vs. Degludec 100 U/mL in patients with type 2 diabetes switching from 1° generation basal insulins. NMCD. NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES, 32(9), 2255-2263 [10.1016/j.numecd.2022.06.003].
Comparative effectiveness of Glargine 300 U/mL vs. Degludec 100 U/mL in patients with type 2 diabetes switching from 1° generation basal insulins
Cucinotta, Domenico
2022
Abstract
Background and aims: Data on second generation basal insulin (2BI) in people with type 2 diabetes (T2D) generated by clinical trials still need confirmation in real-world clinical set-tings. This study aimed at assessing the comparative effectiveness of 2BI [Glargine 300 U/mL (Gla-30 0) vs. Degludec 100 U/mL (Deg-10 0)] in T2D Italian patients switching from first gener-ation basal insulins (1BI).Methods and results: This was a retrospective, non-inferiority, multicenter study. Patients switch-ing to Gla-30 0 or Deg-10 0 from 1BI were 1:1 propensity score matched (PSM). Changes during 6 months in continuous endpoints were assessed through linear mixed models. Incidence rates (IR) of hypoglycemia (episodes per patient-months) were compared using Poisson regression.Each PSM cohort included 593 patients. HbA1c decreased from baseline (8.7%) to 6 months by-0.58% (95%CI-0.69;-0.47) in Gla-30 0 group and-0.50% (95%CI-0.61;-0.39) in Deg-10 0 group, confirming the non-inferiority of Gla-30 0 vs. Deg-100. No between-group differences emerged: FBG was reduced by about 20 mg/dl with both 2BI, mean dose of 2BI (24.5 U, 0.3 U/Kg at the first prescription) was suboptimally titrated during 6 months (+1.34 U in Gla-30 0 and + 1.76 U in Deg-10 0), body weight showed minor changes.IR of hypoglycemia <54 mg/dl was 0.32 (95%CI 0.21; 0.49) in Gla-30 0 group and 0.19 (95%CI 0.11; 0.33) in Deg-10 0 group (p Z 0.14). Conclusion: In subjects with T2D, switching to 2BI from 1BI was associated with similar improve-ments in glycemic control, low hypoglycemia rates and no weight gain in real-life setting. Clinical inertia, represented by late treatment intensification and suboptimal titration, represents a major issue in Italy. 2022 The Author(s). Published by Elsevier B.V. on behalf of The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
