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Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)

NCT02580877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2020-07-27

Study results available
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Summary

The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).

Conditions

Interventions

DRUG

67.5 mg oral insulin crystals daily

human insulin crystals in capsules

DRUG

500mg oral insulin crystals every other week

human insulin crystals in capsules

Sponsors & Collaborators

  • Type 1 Diabetes TrialNet

    collaborator NETWORK

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Carla Greenbaum, MD · Type 1 Diabetes TrialNet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States
  • Australia
  • Canada
  • Italy

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 NCT02580877 on ClinicalTrials.gov