NCT02580877

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Geographic Reach
4 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 27, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

September 30, 2015

Results QC Date

February 4, 2020

Last Update Submit

July 24, 2020

Conditions

Type 1 Diabetes

Keywords

oral insulin

Outcome Measures

Primary Outcomes (2)

  • Change in GAD65 Autoantibody Titer (DK Units/mL)

    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

    Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response

    13 and 26 weeks after first dose versus baseline

Study Arms (2)

67.5 mg oral insulin crystals daily

EXPERIMENTAL

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

500mg oral insulin crystals every other week

EXPERIMENTAL

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

Interventions

67.5 mg oral insulin crystals dailyDRUG

human insulin crystals in capsules

Also known as: Humulin R crystals
67.5 mg oral insulin crystals daily
500mg oral insulin crystals every other weekDRUG

human insulin crystals in capsules

Also known as: Humulin R crystals
500mg oral insulin crystals every other week

Eligibility Criteria

Age3 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of California - San Francisco

San Francisco, California, 94158-2549, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80109, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University-Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Columbia University-Naomi Berrie Diabetes Center

New York, New York, 10032, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Benaroya Research Institute

Seattle, Washington, 98101, United States

Location

Walter and Eliza Hall Institute of Medical Research

Parkville, Victoria, 3050, Australia

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

San Raffaele Hospital

Milan, Italy

Location

Related Publications (3)

  • Skyler JS, Krischer JP, Wolfsdorf J, Cowie C, Palmer JP, Greenbaum C, Cuthbertson D, Rafkin-Mervis LE, Chase HP, Leschek E. Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1. Diabetes Care. 2005 May;28(5):1068-76. doi: 10.2337/diacare.28.5.1068.

    PMID: 15855569BACKGROUND

  • Bonifacio E, Ziegler AG, Klingensmith G, Schober E, Bingley PJ, Rottenkolber M, Theil A, Eugster A, Puff R, Peplow C, Buettner F, Lange K, Hasford J, Achenbach P; Pre-POINT Study Group. Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. JAMA. 2015 Apr 21;313(15):1541-9. doi: 10.1001/jama.2015.2928.

    PMID: 25898052BACKGROUND

  • Jacobsen LM, Schatz DA. Insulin immunotherapy for pretype 1 diabetes. Curr Opin Endocrinol Diabetes Obes. 2021 Aug 1;28(4):390-396. doi: 10.1097/MED.0000000000000648.

    PMID: 34091488DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Carla Greenbaum, MD
Organization
Benaroya Research Institute
cjgreen@benaroyaresearch.org
1-800-425-8631

Study Officials

  • Carla Greenbaum, MD

    Type 1 Diabetes TrialNet

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 20, 2015

Study Start

January 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 27, 2020

Results First Posted

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Data will be available at the NIDDK Central Repository

More information

Locations

IT(1)AU(1)CA(1)US(16)