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

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

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

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.

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