Clinical trial NCT03352674: Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
Official title: Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: insulin glargine
diabetes mellitus
immunogenicity
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of immune response
timeFrame: 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: 6 months
measure: Fasting blood glucose
timeFrame: 6 months
measure: Hypoglycemia
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia
state: Jakarta
Study officials:
affiliation: Cipto Mangunkusumo Hospital/Faculty of Medicine Universities Indonesia
name: Tri Juli Edi Tarigan, MD
role: PRINCIPAL_INVESTIGATOR
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