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

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ClinicalTrials.gov Identifier: NCT03352674
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Tri Juli Edi Tarigan, SpPD-KEMD, Indonesia University

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Insulin Glargine Ezelin Drug: Insulin Glargine Pen Injector [Lantus] Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin Glargine Ezelin
Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)
Drug: Insulin Glargine Ezelin
Insulin Glargine (Ezelin) once daily at individually adjusted dose
Other Name: Ezelin

Active Comparator: Insulin Glargine Lantus
Insulin Glargine Pen Injector [Lantus]
Drug: Insulin Glargine Pen Injector [Lantus]
Insulin Glargine (Lantus) once daily at individually adjusted dose
Other Name: Lantus




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]
    change in HbA1c level after 6 months of therapy compared to baseline value

  2. Fasting blood glucose [ Time Frame: 6 months ]
    Change in fasting blood glucose

  3. Hypoglycemia [ Time Frame: 6 months ]
    Incidence and severity of hypoglycaemia cases

  4. Adverse events [ Time Frame: 6 months ]
    Incidence and severity of adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352674


Contacts
Contact: Melva Louisa, PhD melva.louisa@gmail.com
Contact: Adisti Dwijayanti, MD adistimiltiades@gmail.com

Locations
Indonesia
Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia Recruiting
Jakarta Pusat, Jakarta, Indonesia, 10520
Contact: Tri Juli Edi Tarigan, MD       tje_tar@yahoo.com   
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Tri Juli Edi Tarigan, MD Cipto Mangunkusumo Hospital/Faculty of Medicine Universities Indonesia

Publications of Results:

Responsible Party: Dr Tri Juli Edi Tarigan, SpPD-KEMD, Endocrinologist, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03352674     History of Changes
Other Study ID Numbers: IndonesiaU-01
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Tri Juli Edi Tarigan, SpPD-KEMD, Indonesia University:
insulin glargine
diabetes mellitus
immunogenicity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs