MedTrace Logo

The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus

NCT04591457 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-10-19

No results posted yet for this study

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

Conditions

Interventions

DRUG

Insulin Glargine Sansulin

Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose

DRUG

Insulin Glargine Pen Injector [Lantus]

Insulin Glargine (Lantus) once daily at individually adjusted dose

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Tri Juli Edi Tarigan · Cipto Mangunkusumo General Hospital/Faculty of Medicine Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04591457 on ClinicalTrials.gov