Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
NCT ID: NCT03352674
Last Updated: 2020-04-01
Study Results
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Basic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2016-09-30
2018-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Insulin Glargine Ezelin
Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)
Insulin Glargine Ezelin
Insulin Glargine (Ezelin) once daily at individually adjusted dose
Insulin Glargine Lantus
Insulin Glargine Pen Injector \[Lantus\]
Insulin Glargine Pen Injector [Lantus]
Insulin Glargine (Lantus) once daily at individually adjusted dose
Interventions
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Insulin Glargine Ezelin
Insulin Glargine (Ezelin) once daily at individually adjusted dose
Insulin Glargine Pen Injector [Lantus]
Insulin Glargine (Lantus) once daily at individually adjusted dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diabetes mellitus type 2 patients who has failed an oral hypoglycemic drug products, insulin-naive, disease duration of at least 6 months, inadequate glycemic control (HbA1c \> 7.0 %)
* BMI ranged from 19 - 35 kg/m2
* Consent from patients of childbearing potential to use contraception method throughout the study
* Signed informed consent form
Exclusion Criteria
* History of pancreatectomy
* Estimated glomerular filtration rate \<30 mL/min
* Positive ZnT8 Antibody
* Treatment with glucocorticoids, immunodepressant or cytostatics in 60 days before study.
* Any malignant disease, including in medical history
* Drugs and alcohol abuse, including in medical history
* Hipersensitivity to insulin glargine or any excipient of the drugs from medical history
* Mental disorders
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Dr Tri Juli Edi Tarigan, SpPD-KEMD
Endocrinologist, Principal Investigator
Principal Investigators
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Tri Juli Edi Tarigan, MD
Role: PRINCIPAL_INVESTIGATOR
Cipto Mangunkusumo Hospital/Faculty of Medicine Universities Indonesia
Locations
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Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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References
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Chakkarwar PN, Manjrekar NA. Insulin glargine: a long acting insulin analog. J Postgrad Med. 2005 Jan-Mar;51(1):68-71.
McKeage K, Goa KL. Insulin glargine: a review of its therapeutic use as a long-acting agent for the management of type 1 and 2 diabetes mellitus. Drugs. 2001;61(11):1599-624. doi: 10.2165/00003495-200161110-00007.
Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, Davidson MB, Einhorn D, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez G, Davidson MH; American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013 Mar-Apr;19(2):327-36. doi: 10.4158/endp.19.2.a38267720403k242. No abstract available.
Pihoker C, Gilliam LK, Hampe CS, Lernmark A. Autoantibodies in diabetes. Diabetes. 2005 Dec;54 Suppl 2:S52-61. doi: 10.2337/diabetes.54.suppl_2.s52.
Bingley PJ. Clinical applications of diabetes antibody testing. J Clin Endocrinol Metab. 2010 Jan;95(1):25-33. doi: 10.1210/jc.2009-1365. Epub 2009 Oct 29.
Vaziri-Sani F, Oak S, Radtke J, Lernmark K, Lynch K, Agardh CD, Cilio CM, Lethagen AL, Ortqvist E, Landin-Olsson M, Torn C, Hampe CS. ZnT8 autoantibody titers in type 1 diabetes patients decline rapidly after clinical onset. Autoimmunity. 2010 Dec;43(8):598-606. doi: 10.3109/08916930903555927. Epub 2010 Mar 19.
Pan CY, Sinnassamy P, Chung KD, Kim KW; LEAD Study Investigators Group. Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients. Diabetes Res Clin Pract. 2007 Apr;76(1):111-8. doi: 10.1016/j.diabres.2006.08.012. Epub 2006 Oct 2.
Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman A. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care. 2005 Apr;28(4):950-5. doi: 10.2337/diacare.28.4.950.
Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.
Rosenstock J, Schwartz SL, Clark CM Jr, Park GD, Donley DW, Edwards MB. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care. 2001 Apr;24(4):631-6. doi: 10.2337/diacare.24.4.631.
Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet. 2005 Apr 9-15;365(9467):1333-46. doi: 10.1016/S0140-6736(05)61032-X.
Rubin RR, Peyrot M, Siminerio LM. Health care and patient-reported outcomes: results of the cross-national Diabetes Attitudes, Wishes and Needs (DAWN) study. Diabetes Care. 2006 Jun;29(6):1249-55. doi: 10.2337/dc05-2494.
Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.
Yki-Jarvinen H, Juurinen L, Alvarsson M, Bystedt T, Caldwell I, Davies M, Lahdenpera S, Nijpels G, Vahatalo M. Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups. Diabetes Care. 2007 Jun;30(6):1364-9. doi: 10.2337/dc06-1357. Epub 2007 Mar 23.
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. Diabetes Metab Syndr Obes. 2021 Jan 12;14:107-116. doi: 10.2147/DMSO.S279385. eCollection 2021.
Other Identifiers
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IndonesiaU-01
Identifier Type: -
Identifier Source: org_study_id
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