Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

Overview

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients

Full Title of Study: “Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 1, 2018

Detailed Description

Previous study has revealed that Insulin Glargine (Kalbe Farma) has similar efficacy with Lantus (Sanofi-Aventis) in controlling blood glucose in type 2 diabetes mellitus patients, but the immunogenicity potential of this product has not been known. Therefore, the present study is aiming to compare immunogenicity of Insulin Glargine (Kalbe Farma) and Lantus (Sanofi-Aventis) in type 2 diabetes mellitus patients in an open-label randomised multicenter clinical study.

Interventions

  • Drug: Insulin Glargine Ezelin
    • Insulin Glargine (Ezelin) once daily at individually adjusted dose
  • Drug: Insulin Glargine Pen Injector [Lantus]
    • Insulin Glargine (Lantus) once daily at individually adjusted dose

Arms, Groups and Cohorts

  • Experimental: Insulin Glargine Ezelin
    • Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)
  • Active Comparator: Insulin Glargine Lantus
    • Insulin Glargine Pen Injector [Lantus]

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of immune response
    • Time Frame: 6 months
    • Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups

Secondary Measures

  • HbA1c
    • Time Frame: 6 months
    • change in HbA1c level after 6 months of therapy compared to baseline value
  • Fasting blood glucose
    • Time Frame: 6 months
    • Change in fasting blood glucose
  • Hypoglycemia
    • Time Frame: 6 months
    • Incidence and severity of hypoglycaemia cases
  • Adverse events
    • Time Frame: 6 months
    • Incidence and severity of adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Men or women, 18 years old and above – 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 diabetic ketoacidosis more than 2 times in the past 1 year – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Tri Juli Edi Tarigan, SpPD-KEMD, Endocrinologist, Principal Investigator – Indonesia University
  • Overall Official(s)
    • Tri Juli Edi Tarigan, MD, Principal Investigator, Cipto Mangunkusumo Hospital/Faculty of Medicine Universities Indonesia

Citations Reporting on Results

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.

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