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NCT Number: NCT03352674

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Jakarta Pusat, Jakarta Special Capital Region, 10520, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Glargine Ezelin

Drug

Insulin Glargine (Ezelin) once daily at individually adjusted dose

Other names: Ezelin

Insulin Glargine Pen Injector [Lantus]

Drug

Insulin Glargine (Lantus) once daily at individually adjusted dose

Other names: Lantus

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2017
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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