Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-13 @ 12:34 PM
Study NCT ID:
NCT04591457
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2020-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus
Sponsor:
Indonesia University
Organization:
Study Overview
Official Title:
The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin® Log-G With Its Reference Lantus® in Patients With Type 2 Diabetes Mellitus
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients
Detailed Description:
Sansulin® Log-G is an insulin glargine biosimilar. For a biosimilar, its efficacy, safety, and immunogenicity should be compared head-to-head with its reference product in at least non-inferiority study. Immunogenicity assessment should always be done because it is influenced by so many factors, from nature of the drug substance until patient and disease related factors. Moreover its consequences also vary considerably, from clinically irrelevant to serious and life-threatening. Immunogenicity of a biosimilar should always be investigated in humans, since animal data are usually not predictive of the immune response in humans.
Since blinding of study participants is likely unfeasible, at least anti-drug antibodies should be determined in a blinded fashion. Since anti-insulin antibodies develop early, then 6 months duration of study is adequate.
Since blinding of study participants is likely unfeasible, at least anti-drug antibodies should be determined in a blinded fashion. Since anti-insulin antibodies develop early, then 6 months duration of study is adequate.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: