| Trial ID: | L2408 |
| Source ID: | NCT03352674
|
| Associated Drug: |
Insulin Glargine Ezelin
|
| Title: |
Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin Glargine Ezelin|DRUG: Insulin Glargine Pen Injector [Lantus]
|
| Outcome Measures: |
Primary: Incidence of immune response, Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups, 6 months | Secondary: HbA1c, change in HbA1c level after 6 months of therapy compared to baseline value, 6 months|Fasting blood glucose, Change in fasting blood glucose, 6 months|Hypoglycemia, Incidence and severity of hypoglycaemia cases, 6 months|Adverse events, Incidence and severity of adverse events, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Indonesia University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
133
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-09
|
| Completion Date: |
2018-12-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-04-01
|
| Locations: |
Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia, Jakarta Pusat, Jakarta, 10520, Indonesia
|
| URL: |
https://clinicaltrials.gov/show/NCT03352674
|
