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

July 24, 2020 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A minimum of 40 eligible participants will be identified for study participation from the TrialNet Pathway to Prevention study. Participants must have a relative with type 1 diabetes and be positive for insulin autoantibodies and at least one other autoantibody. All participants will receive active treatment of recombinant insulin treatment in capsules of either 67.5 mg daily or 500mg every other week. Participants will need to visit the study site up to eleven times over one year for blood tests and other study procedures. During the beginning treatment phase there are two visits one month apart for those given the 67.5 mg dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment group. There are three additional treatment visits at months 2, 3, and 6 and 4 additional visits for follow-up at months 7, 8, 9 and 12. The primary outcome is the change in immune function as assessed by change in level or quality of T lymphocyte or autoantibody biomarkers measured between 13 and 26 weeks compared to baseline. .

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Walter and Eliza Hall Institute of Medical Research
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children
  • Italy
      • Milan, Italy
        • San Raffaele Hospital
  • United States
    • California
      • San Francisco, California, United States, 94158-2549
        • University of California - San Francisco
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80109
        • Barbara Davis Center for Childhood Diabetes
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Children's Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University-Riley Hospital for Children
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University-Naomi Berrie Diabetes Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • University of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is relative of proband with type 1 diabetes
  • Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT
  • Confirmed positive for insulin autoantibodies within previous six months
  • Confirmed positive for one or more other autoantibodies on two separate occasions within the past six months

Exclusion Criteria:

  • Diagnosed with type 1 diabetes
  • History of treatment with insulin or oral hypoglycemic agent
  • History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months
  • Ongoing use of medications known to influence glucose tolerance
  • Pregnant or intending to become pregnant while on study or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 67.5 mg oral insulin crystals daily
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
Drug: 67.5 mg oral insulin crystals daily
human insulin crystals in capsules
Other Names:
  • Humulin R crystals
Experimental: 500mg oral insulin crystals every other week
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
Drug: 500mg oral insulin crystals every other week
human insulin crystals in capsules
Other Names:
  • Humulin R crystals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GAD65 Autoantibody Titer (DK Units/mL)
Time Frame: 13 and 26 weeks after first dose versus baseline
Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response
13 and 26 weeks after first dose versus baseline
Change in mIAA Autoantibody Titer From Baseline
Time Frame: 13 and 26 weeks after first dose versus baseline
Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response
13 and 26 weeks after first dose versus baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Type 1 Diabetes TrialNet

Investigators

  • Study Chair: Carla Greenbaum, MD, Type 1 Diabetes TrialNet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral Insulin-TN20
  • UC4DK117009 (U.S. NIH Grant/Contract)
  • UC4DK106993 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available at the NIDDK Central Repository

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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