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Study of Tolerability and Safety of Adding Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With TD1 Melitis

NCT02204397 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-05-30

No results posted yet for this study

Summary

A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in patients with established T1DM.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

INGAP Peptide, Ustekinumab

Sponsors & Collaborators

  • Jewish General Hospital

    lead OTHER

Principal Investigators

  • George Tsoukas, MD · Department of Endocrinology and Metabolism, Montreal General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-03-08
Completion
2017-03-08

Countries

  • Canada

Study Locations

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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 NCT02204397 on ClinicalTrials.gov