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

NCT03352674 | Completed Phase 2 DMC

• 1 other identifier: IndonesiaU-01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

insulin glargine; diabetes mellitus; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Incidence of immune response

  Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups

  6 months

Secondary Outcomes (4)

• HbA1c

  6 months

• Fasting blood glucose

  6 months

• Hypoglycemia

  6 months

• Adverse events

  6 months

Study Arms (2)

Insulin Glargine Ezelin

EXPERIMENTAL

Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)

Drug: Insulin Glargine Ezelin

Insulin Glargine Lantus

ACTIVE COMPARATOR

Insulin Glargine Pen Injector \[Lantus\]

Drug: Insulin Glargine Pen Injector [Lantus]

Interventions

Insulin Glargine Ezelin DRUG

Insulin Glargine (Ezelin) once daily at individually adjusted dose

Also known as: Ezelin

Insulin Glargine Ezelin

Insulin Glargine Pen Injector [Lantus] DRUG

Insulin Glargine (Lantus) once daily at individually adjusted dose

Also known as: Lantus

Insulin Glargine Lantus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10520, Indonesia

Location

Related Publications (15)

• Chakkarwar PN, Manjrekar NA. Insulin glargine: a long acting insulin analog. J Postgrad Med. 2005 Jan-Mar;51(1):68-71.

  PMID: 15793346 RESULT

• 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.

  PMID: 11577797 RESULT

• 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.

  PMID: 23598536 RESULT

• 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.

  PMID: 16306341 RESULT

• 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.

  PMID: 19875480 RESULT

• 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.

  PMID: 20298127 RESULT

• 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.

  PMID: 17011662 RESULT

• 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.

  PMID: 15793205 RESULT

• 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.

  PMID: 18204830 RESULT

• 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.

  PMID: 11315821 RESULT

• 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.

  PMID: 15823385 RESULT

• 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.

  PMID: 16732004 RESULT

• 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.

  PMID: 15111519 RESULT

• 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.

  PMID: 17384341 RESULT

• 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.

  PMID: 33469328 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tri Juli Edi Tarigan, MD

  Cipto Mangunkusumo Hospital/Faculty of Medicine Universities Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, Principal Investigator

Study Record Dates

• First Submitted: October 14, 2017
• First Posted: November 24, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)