IDegLira for the real‐world treatment of type 2 diabetes in Italy. Final results from the REX observational study

Author:

Fadini Gian Paolo12ORCID,Buzzetti Raffaella3ORCID,Pitocco Dario4,Tortato Elena5,Scatena Alessia6,Lamacchia Olga7,Lastoria Giusi8,Simoni Lucia9,Consoli Agostino10,

Affiliation:

1. Department of Medicine University of Padova Padua Italy

2. Division of Metabolic Diseases Padova Hospital Padua Italy

3. Department of Experimental Medicine Sapienza University of Rome Rome Italy

4. Diabetology Unit Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy

5. Metabolic Diseases and Diabetology Department, IRCCS INRCA Ancona Italy

6. Diabetology Unit San Donato Hospital Arezzo Italy

7. Endocrinology Unit, Department of Medical and Surgical Sciences University of Foggia Foggia Italy

8. Clinical Medical & Regulatory Department Novo Nordisk SpA Rome Italy

9. Medineos Observational Research, an IQVIA Company Modena Italy

10. Department of Medicine and Aging Sciences (DMSI) and Center for Advanced Studies and Technology (CAST) University G. D'Annunzio Chieti Italy

Abstract

AbstractAimThe study was designed to generate real‐world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal‐bolus insulin regimen (BB group).Materials and MethodsThis was a non‐interventional, multicentre, single‐cohort, prospective study assessing the long‐term glycaemic control in patients with T2D, who switched to IDegLira from a basal insulin ± glucose‐lowering medication regimen with or without a bolus insulin component for approximately 18 months, conducted in 28 Italian diabetes centres. The primary endpoint was the change in glycated haemoglobin (HbA1c) levels from baseline to 6 months after IDegLira initiation.ResultsThe study included 358 patients with a mean age 67.2 years and diabetes duration of 15.7 years. HbA1c significantly decreased from IDegLira start to all study time points in the overall population (basal group −1.19%; BB group −0.60% at the end of observation). Patients achieving HbA1c <7% levels increased from 12.9% (n = 43) to 40.3% (n = 110) at 18 months. Fasting blood glucose and body weight also significantly decreased in both groups, although more in the BB group. Overall, 14.3% of completed patients had an intensification of treatment (mainly in the basal group) and 48.6% had a simplification of treatment (mainly in the BB group).ConclusionsSwitching to IDegLira in a real‐world clinical setting is a valid therapeutic option for patients with T2D with inadequate glycaemic control on basal or BB insulin regimen and/or need to simplify their insulin therapy, with specific reasons and therapeutic goals according to different T2D management trajectories.

Funder

Novo Nordisk

Publisher

Wiley

Reference36 articles.

1. 9. Pharmacologic approaches to glycemic treatment: standards of medical Care in Diabetes—2022;Committee ADAPP;Diabetes Care,2021

2. A review of GLP‐1 receptor agonists in type 2 diabetes: A focus on the mechanism of action of once‐weekly agents

3. Basal Insulin Use With GLP-1 Receptor Agonists

4. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

5. Glucagon‐like peptide‐1 receptor agonists as add‐on therapy to basal insulin in patients with type 2 diabetes: a systematic review;Berlie H;Diabetes Metab Syndr Obes,2012

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