Initiation of the Fixed Combination IDegLira in Patients with Type 2 Diabetes on Prior Injectable Therapy: Insights from the EASY French Real-World Study

Diabetes Therapy - Tập 13 - Trang 1947-1963 - 2022
Blandine Tramunt1,2, Emmanuel Disse3, Nicolas Chevalier4, Lyse Bordier5, Laurent Cazals1, Olivier Dupuy6, Michel Marre7, Odette Matar8, Laurent Meyer9, Chloé Noilhan1, Caroline Sanz10, Paul Valensi11, Fritz-Line Velayoudom12, Jean-François Gautier13,14, Pierre Gourdy1,2
1Service de Diabétologie, Maladies Métaboliques et Nutrition, CHU et Université de Toulouse, Toulouse Cedex 9, France
2Institut des Maladies Métaboliques et Cardiovasculaires, UMR1297 INSERM/UT3, Toulouse, France
3Service d’Endocrinologie, Diabète et Nutrition, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France
4Université Côte d'Azur, Centre Hospitalier Universitaire, Inserm U1065, C3M, Nice, France
5Service d’Endocrinologie, Hôpital d’instruction des Armées Begin, Saint-Mandé, France
6Service de Diabétologie et Endocrinologie, Groupe Hospitalier Saint-Joseph, Paris, France
7Clinique Ambroise Paré, Neuilly-sur-Seine, France
8Service d’Endocrinologie, Diabétologie et Nutrition, Hôpital Bichat, Paris, France
9Service d’Endocrinologie, Diabète et Maladies Métaboliques, CHU de Strasbourg, Strasbourg, France
10Cabinet d’Endocrinologie, de Diabétologie et de Nutrition, Clinique Pasteur, Toulouse, France
11Unit of Endocrinology, Diabetology and Nutrition, Jean Verdier Hospital, Paris Nord University, Bondy, France
12Service d’Endocrinologie-Diabétologie, CHU de Guadeloupe, Pointe-À-Pitre, France
13Service de Diabétologie et d’Endocrinologie, Hôpital Lariboisière, AP-HP, Paris Cité, INSERM 1151, Paris, France
14Université Paris Cité, INSERM UMR-S1151, CNRS UMR-S8253, Institut Necker Enfants Malades, Paris, France

Tóm tắt

Combining basal insulin (BI) with glucagon-like peptide-1 receptor agonist (GLP-1RA) is recognized as a relevant option to optimize glucose control in type 2 diabetes (T2D). The EASY real-world study aimed to evaluate the modalities of initiation and the effectiveness of the insulin Degludec plus Liraglutide (IDegLira) fixed-ratio combination in the French health care system. A retrospective analysis included all patients with T2D and prior injectable therapy (GLP1-RA and/or insulin) who started treatment with IDegLira from September 2016 to December 2017 in 11 French diabetes centers. Baseline characteristics, reasons for IDegLira initiation, and modes of implementation were collected from the medical records. Changes in HbA1c and body weight were determined in patients with available follow-up data (nearest 6-month visit). IDegLira was initiated in 629 patients previously treated with GLP-1RA alone (11.6%), insulin alone (31.5% including 16.5% with BI and 14.9% with multiple daily injections [MDI]) or a free combination of GLP-1RA and insulin (56.9% including 44.8% with BI and 12.1% with MDI), associated or not with oral agents. IDegLira starting dose (mean of 29 ± 11 dose steps) most often exceeded the recommended dose, and was significantly correlated with prior BI but not GLP-1RA dosage. At initiation, mean age, body mass index (BMI) and HbA1c were 60.1 ± 10.2 years, 33.4 ± 6.2 kg/m2 and 8.8 ± 1.7%, respectively. In 461 patients with available follow-up (median 178 days), HbA1c decreased in all subgroups submitted to treatment intensification (− 1.7 ± 1.8% [p < 0.0001], − 1.2 ± 1.8% [p < 0.001] and − 0.8 ± 1.8% [p = 0.0026] in patients with prior GLP-1RA, BI or MDI therapy, respectively) but also in those switching from BI and GLP-1RA free combination (− 0.2 ± 0.9%, p = 0.0419). Significant body weight gain occurred in patients previously treated with GLP-1RA alone (+ 1.5 ± 5.8 kg, p = 0.0572) or combined to BI (+ 1.0 ± 3.1 kg, p < 0.0001) while those on BI (− 1.4 ± 4.6 kg, p = 0.0139) or MDI (− 1.4 ± 5.0 kg, p = 0.0484) experienced weight loss. While providing new information on the use of IDegLira in the French healthcare system, these data confirm the effectiveness of this fixed-ratio combination in the management of T2D.

Tài liệu tham khảo

Holst JJ, Vilsbøll T. Combining GLP-1 receptor agonists with insulin: therapeutic rationales and clinical findings. Diabetes Obes Metab. 2013;15:3–14. American Diabetes Association Professional Practice Committee, Draznin B, Aroda VR, Bakris G, Benson G, Brown FM, et al. 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2022. Diabetes Care. 2022;45:S125–43. Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, et al. Management of hyperglycemia in type 2 diabetes, 2022. A American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022. https://doi.org/10.2337/dci22-0034. Eng C, Kramer CK, Zinman B, Retnakaran R. Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis. Lancet. 2014;384:2228–34. Maiorino MI, Chiodini P, Bellastella G, Capuano A, Esposito K, Giugliano D. Insulin and glucagon-like peptide 1 receptor agonist combination therapy in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care. 2017;40:614–24. Valentine V, Goldman J, Shubrook JH. Rationale for, initiation and titration of the basal insulin/GLP-1RA fixed-ratio combination products, IDegLira and IGlarLixi, for the management of type 2 diabetes. Diabetes Ther. 2017;8:739–52. Perreault L, Rodbard H, Valentine V, Johnson E. Optimizing fixed-ratio combination therapy in type 2 diabetes. Adv Ther. 2019;36:265–77. Harris S, Abrahamson MJ, Ceriello A, Charpentier G, Evans M, Lehmann R, et al. Clinical considerations when initiating and titrating insulin degludec/liraglutide (IDegLira) in people with type 2 diabetes. Drugs. 2020;80:147–65. Rayner CK, Wu T, Aroda VR, Whittington C, Kanters S, Guyot P, et al. Gastrointestinal adverse events with insulin glargine/lixisenatide fixed-ratio combination versus glucagon-like peptide-1 receptor agonist s in people with type 2 diabetes mellitus: a network meta-analysis. Diabetes Obes Metab. 2021;23:136–46. Price H, Blüher M, Prager R, Phan T-M, Thorsted BL, Schultes B, et al. Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: Results from a European, multicentre, retrospective chart review study. Diabetes Obes Metab. 2018;20:954–62. Taybani Z, Bótyik B, Katkó M, Gyimesi A, Várkonyi T. Simplifying complex insulin regimens while preserving good glycemic control in type 2 diabetes. Diabetes Ther. 2019;10:1869–78. Eliasson B, Ekelund J, Miftaraj M, Ranthe MF, Mårdby A-C, Da Rocha Fernandes JD, et al. Persistence with IDegLira in patients in clinical practice: a nationwide observational study in Sweden. Diabetes Ther. 2020;11:1807–20. Zenari L, Da Porto A, De Moliner L, Lugli F, Guazzoni V, Groppelli G, et al. Real-world evaluation of glycemic outcomes and extra-glycemic parameters in diabetic patients treated with the combined formulation degludec-liraglutide (IDegLira). Diabetes Ther. 2021;12:197–209. Persano M, Nollino L, Sambataro M, Rigato M, Negro I, Marchetto S, et al. Real-world study on the effectiveness and safety of basal insulin IDegLira in type 2 diabetic patients previously treated with multi-injective insulin therapy. Eur Rev Med Pharmacol Sci. 2021;25:923–31. Melzer-Cohen C, Chodick G, Naftelberg S, Shehadeh N, Karasik A. Metabolic control and adherence to therapy in type 2 diabetes mellitus patients using IDegLira in a real-world setting. Diabetes Ther. 2020;11:185–96. Egede LE, Bogdanov A, Fischer L, Da Rocha Fernandes JD, Kallenbach L. Glycemic control among patients newly prescribed IDegLira across prior therapy group in US real-world practice. Diabetes Ther. 2020;11:1579–89. Buse JB, Vilsbøll T, Thurman J, Blevins TC, Langbakke IH, Bøttcher SG, et al. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014;37:2926–33. Lingvay I, Pérez Manghi F, García-Hernández P, Norwood P, Lehmann L, Tarp-Johansen MJ, et al. Effect of insulin glargine up-titration vs insulin degludec/liraglutide on glycated hemoglobin levels in patients with uncontrolled type 2 diabetes: the DUAL V randomized clinical trial. JAMA. 2016;315:898–907. Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, et al. Efficacy and safety of IDegLira versus basal-bolus insulin therapy in patients with type 2 diabetes uncontrolled on metformin and basal insulin: the DUAL VII randomized clinical trial. Diabetes Care. 2018;41:1009–16. Linjawi S, Bode BW, Chaykin LB, Courrèges J-P, Handelsman Y, Lehmann LM, et al. The efficacy of IDegLira (insulin degludec/liraglutide combination) in adults with type 2 diabetes inadequately controlled with a GLP-1 receptor agonist and oral therapy: dual III randomized clinical trial. Diabetes Ther. 2017;8:101–14. Giugliano D, Scappaticcio L, Longo M, Caruso P, Maiorino MI, Bellastella G, et al. Simplification of complex insulin therapy: a story of dogma and therapeutic resignation. Diabetes Res Clin Pract. 2021;178: 108958. Giugliano D, Longo M, Caruso P, Di Fraia R, Scappaticcio L, Gicchino M, et al. Feasibility of simplification from a basal-bolus insulin regimen to a fixed-ratio formulation of basal insulin plus a GLP-1RA or to basal insulin plus an SGLT2 inhibitor: BEYOND, a randomized. Pragmat Trial Diabetes Care. 2021;44:1353–60. Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JFE, Nauck MA, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311–22. Fadini GP, Buzzetti R, Fittipaldi MR, D’Incau F, Da Porto A, Girelli A, et al. IDegLira for the real-world treatment of type 2 diabetes in Italy: protocol and interim results from the REX observational study. Diabetes Ther. 2022;13:1483–97. Kalra S, Bhattacharya S, Kapoor N. Contemporary classification of glucagon-like peptide 1 receptor agonists (GLP1RAs). Diabetes Ther. 2021;12:2133–47.