Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes

Tri Juli Edi Tarigan,1 Adisti Dwijayanti,2 Susie Setyowati,3 Melva Louisa4 1Division of Endocrinology and Metabolism, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; 2Department of Medical Pharmacy, F...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Tarigan TJE, Dwijayanti A, Setyowati S, Louisa M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	biosimilar insulin autoantibody zinc transporter 8 antibody hyperglycemia Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/e27ef62c838e4bd0b2b40e3c8d590d0a
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:e27ef62c838e4bd0b2b40e3c8d590d0a
record_format	dspace
spelling	oai:doaj.org-article:e27ef62c838e4bd0b2b40e3c8d590d0a2021-12-02T15:14:37ZImmunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes1178-7007https://doaj.org/article/e27ef62c838e4bd0b2b40e3c8d590d0a2021-01-01T00:00:00Zhttps://www.dovepress.com/immunogenicity-and-efficacy-of-insulin-glargine-biosimilar-ezelin-vers-peer-reviewed-article-DMSOhttps://doaj.org/toc/1178-7007Tri Juli Edi Tarigan,1 Adisti Dwijayanti,2 Susie Setyowati,3 Melva Louisa4 1Division of Endocrinology and Metabolism, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; 2Department of Medical Pharmacy, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; 3Division of Endocrinology, Department of Internal Medicine, Gatot Soebroto Presidential Hospital, Jakarta, Indonesia; 4Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia, Jakarta, IndonesiaCorrespondence: Tri Juli Edi TariganDivision of Endocrinology and Metabolism, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, IndonesiaTel +62 21-3907703Email tri.judi@ui.ac.idPurpose: To compare the immunogenicity and efficacy of insulin glargine biosimilar Ezelin (EZL) versus originator insulin glargine Lantus (LAN) as a reference basal insulin in patients with type 2 diabetes (T2D).Patients and Methods: This was a randomized, multicenter, open-label, 24-week study in insulin-naïve patients with T2D, with HbA1c of > 7.0%. We randomly assigned 133 eligible patients to receive either EZL or LAN. Baseline characteristics, including insulin autoantibody (IAA), zinc transporter 8 (ZnT8) antibody, HbA1C, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPPG), AST, ALT, BUN, eGFR, and oral antidiabetic drugs, were obtained before starting insulin treatment. After starting treatment, insulin dose was titrated to achieve FPG target along with oral antidiabetic drugs. Patients were given home glucometer and assisted to record plasma glucose measurement and adverse event (AE). Every month, patients came to the diabetes clinic and performed a regular physical examination and intensifying treatment if needed. Out of the 133 randomized patients, only 122 completed the study and can be examined for their IAA and ZnT8 after 6 months of treatment. The study was registered in clinicaltrials.gov, NCT03352674.Results: There is a similar proportion of patients with changes of IAA from baseline: 1 out of 58 (1.7%) patients receiving EZL versus 1 out of 64 (1.6%) patients receiving LAN (p = 1.000). One patient in the EZL group (1.7%) versus none in the LAN group experienced a change of ZnT8 antibody from baseline. Similar glucose control in EZL versus LAN was determined by the change in HbA1c, FPG, and 2hPPG (− 2.0%, − 67.46 mg/dL, and − 76.51 mg/dL in the EZL group versus − 1.7%, − 58.11 mg/dL, and − 70.03 mg/dL in the LAN group). There were six events of documented hypoglycemia in the EZL group versus five events in the LAN group. No patients experienced diabetic ketoacidosis during the study.Conclusion: Overall, insulin glargine biosimilar EZL and originator insulin glargine LAN have shown a similar immunogenicity profile, as well as efficacy in providing glucose control and safety findings in T2D populations.Keywords: biosimilar, insulin autoantibody, zinc transporter 8 antibody, hyperglycemiaTarigan TJEDwijayanti ASetyowati SLouisa MDove Medical Pressarticlebiosimilarinsulin autoantibodyzinc transporter 8 antibodyhyperglycemiaSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol Volume 14, Pp 107-116 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	biosimilar insulin autoantibody zinc transporter 8 antibody hyperglycemia Specialties of internal medicine RC581-951
spellingShingle	biosimilar insulin autoantibody zinc transporter 8 antibody hyperglycemia Specialties of internal medicine RC581-951 Tarigan TJE Dwijayanti A Setyowati S Louisa M Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes
description	Tri Juli Edi Tarigan,1 Adisti Dwijayanti,2 Susie Setyowati,3 Melva Louisa4 1Division of Endocrinology and Metabolism, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; 2Department of Medical Pharmacy, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; 3Division of Endocrinology, Department of Internal Medicine, Gatot Soebroto Presidential Hospital, Jakarta, Indonesia; 4Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia, Jakarta, IndonesiaCorrespondence: Tri Juli Edi TariganDivision of Endocrinology and Metabolism, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, IndonesiaTel +62 21-3907703Email tri.judi@ui.ac.idPurpose: To compare the immunogenicity and efficacy of insulin glargine biosimilar Ezelin (EZL) versus originator insulin glargine Lantus (LAN) as a reference basal insulin in patients with type 2 diabetes (T2D).Patients and Methods: This was a randomized, multicenter, open-label, 24-week study in insulin-naïve patients with T2D, with HbA1c of > 7.0%. We randomly assigned 133 eligible patients to receive either EZL or LAN. Baseline characteristics, including insulin autoantibody (IAA), zinc transporter 8 (ZnT8) antibody, HbA1C, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPPG), AST, ALT, BUN, eGFR, and oral antidiabetic drugs, were obtained before starting insulin treatment. After starting treatment, insulin dose was titrated to achieve FPG target along with oral antidiabetic drugs. Patients were given home glucometer and assisted to record plasma glucose measurement and adverse event (AE). Every month, patients came to the diabetes clinic and performed a regular physical examination and intensifying treatment if needed. Out of the 133 randomized patients, only 122 completed the study and can be examined for their IAA and ZnT8 after 6 months of treatment. The study was registered in clinicaltrials.gov, NCT03352674.Results: There is a similar proportion of patients with changes of IAA from baseline: 1 out of 58 (1.7%) patients receiving EZL versus 1 out of 64 (1.6%) patients receiving LAN (p = 1.000). One patient in the EZL group (1.7%) versus none in the LAN group experienced a change of ZnT8 antibody from baseline. Similar glucose control in EZL versus LAN was determined by the change in HbA1c, FPG, and 2hPPG (− 2.0%, − 67.46 mg/dL, and − 76.51 mg/dL in the EZL group versus − 1.7%, − 58.11 mg/dL, and − 70.03 mg/dL in the LAN group). There were six events of documented hypoglycemia in the EZL group versus five events in the LAN group. No patients experienced diabetic ketoacidosis during the study.Conclusion: Overall, insulin glargine biosimilar EZL and originator insulin glargine LAN have shown a similar immunogenicity profile, as well as efficacy in providing glucose control and safety findings in T2D populations.Keywords: biosimilar, insulin autoantibody, zinc transporter 8 antibody, hyperglycemia
format	article
author	Tarigan TJE Dwijayanti A Setyowati S Louisa M
author_facet	Tarigan TJE Dwijayanti A Setyowati S Louisa M
author_sort	Tarigan TJE
title	Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes
title_short	Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes
title_full	Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes
title_fullStr	Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes
title_full_unstemmed	Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes
title_sort	immunogenicity and efficacy of insulin glargine biosimilar ezelin versus originator insulin glargine in patients with type 2 diabetes
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/e27ef62c838e4bd0b2b40e3c8d590d0a
work_keys_str_mv	AT tarigantje immunogenicityandefficacyofinsulinglarginebiosimilarezelinversusoriginatorinsulinglargineinpatientswithtype2diabetes AT dwijayantia immunogenicityandefficacyofinsulinglarginebiosimilarezelinversusoriginatorinsulinglargineinpatientswithtype2diabetes AT setyowatis immunogenicityandefficacyofinsulinglarginebiosimilarezelinversusoriginatorinsulinglargineinpatientswithtype2diabetes AT louisam immunogenicityandefficacyofinsulinglarginebiosimilarezelinversusoriginatorinsulinglargineinpatientswithtype2diabetes
_version_	1718387603998244864

Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes

Ejemplares similares