Diabetes Mellitus
Conditions
Keywords
insulin glargine, diabetes mellitus, immunogenicity
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.
Interventions
DRUGInsulin Glargine Ezelin
Insulin Glargine (Ezelin) once daily at individually adjusted dose
Insulin Glargine (Lantus) once daily at individually adjusted dose
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of immune response | 6 months | Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months | change in HbA1c level after 6 months of therapy compared to baseline value |
| Fasting blood glucose | 6 months | Change in fasting blood glucose |
| Hypoglycemia | 6 months | Incidence and severity of hypoglycaemia cases |
| Adverse events | 6 months | Incidence and severity of adverse events |
Countries
Indonesia
Outcome results
None listed