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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Glargine Ezelin
* Drug: Insulin Glargine Pen Injector [Lantus]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Glargine Ezelin<br>Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk) | Drug: Insulin Glargine Ezelin<br>* Insulin Glargine (Ezelin) once daily at individually adjusted dose<br>* Other names: Ezelin;|
| Active Comparator: Insulin Glargine Lantus<br>Insulin Glargine Pen Injector [Lantus] | Drug: Insulin Glargine Pen Injector [Lantus]<br>* Insulin Glargine (Lantus) once daily at individually adjusted dose<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of immune response | Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin glargine, diabetes mellitus, immunogenicity