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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

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