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

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Insulin Glargine Ezelin; Drug: Insulin Glargine Pen Injector [Lantus]

• Registration Number: NCT03352674
• Lead Sponsor: 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

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-10-14
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Glargine Ezelin	Insulin Glargine Ezelin	Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)
Insulin Glargine Lantus	Insulin Glargine Pen Injector [Lantus]	Insulin Glargine Pen Injector \[Lantus\]

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia