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Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

NCT03352674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2020-04-01

No results posted yet for this study

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

Conditions

Interventions

DRUG

Insulin Glargine Ezelin

Insulin Glargine (Ezelin) 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, MD · Cipto Mangunkusumo Hospital/Faculty of Medicine Universities Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-12-01
Completion
2018-12-01

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 NCT03352674 on ClinicalTrials.gov