Status:
COMPLETED
Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Indonesia University
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patie...
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 immunogenic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT03352674
Start Date
September 1 2016
End Date
December 1 2018
Last Update
April 1 2020
Active Locations (1)
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1
Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10520