| Trial ID: | L3126 |
| Source ID: | NCT04591457
|
| Associated Drug: |
Insulin Glargine Sansulin
|
| Title: |
The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin Glargine Sansulin|DRUG: Insulin Glargine Pen Injector [Lantus]
|
| Outcome Measures: |
Primary: HbA1c, Change in HbA1c level after 24 weeks of therapy compared to baseline value, 24 weeks|Number of patients, Number of patients with HbA1c \< 7%, 24 weeks|Anti-insulin antibodies (AIAs), Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value, 24 weeks | Secondary: FBG & PPBG, Change in FBG \& PPBG compared to baseline, 24 weeks|Hypoglycemia, Incidence and severity of hypoglycemia, 24 weeks|Weight gain, Incidence of weight gain, 24 weeks|Adverse events, Incidence and severity of adverse events, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Indonesia University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-10
|
| Completion Date: |
2021-08
|
| Results First Posted: |
|
| Last Update Posted: |
2020-10-19
|
| Locations: |
Department of Internal Medicine Cipto Mangunkusumo General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta Pusat, Jakarta, 10520, Indonesia
|
| URL: |
https://clinicaltrials.gov/show/NCT04591457
|
