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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02580877




Registration number
NCT02580877
Ethics application status
Date submitted
30/09/2015
Date registered
20/10/2015
Date last updated
27/07/2020

Titles & IDs
Public title
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Scientific title
Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1
Secondary ID [1] 0 0
UC4DK106993
Secondary ID [2] 0 0
Oral Insulin-TN20
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 67.5 mg oral insulin crystals daily
Treatment: Drugs - 500mg oral insulin crystals every other week

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

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


Treatment: Drugs: 67.5 mg oral insulin crystals daily
human insulin crystals in capsules

Treatment: Drugs: 500mg oral insulin crystals every other week
human insulin crystals in capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in GAD65 Autoantibody Titer (DK Units/mL)
Timepoint [1] 0 0
13 and 26 weeks after first dose versus baseline
Primary outcome [2] 0 0
Change in mIAA Autoantibody Titer From Baseline
Timepoint [2] 0 0
13 and 26 weeks after first dose versus baseline

Eligibility
Key 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
Minimum age
3 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2018
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Walter and Eliza Hall Institute of Medical Research - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Italy
State/province [14] 0 0
Milan

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Type 1 Diabetes TrialNet
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02580877
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Carla Greenbaum, MD
Address 0 0
Type 1 Diabetes TrialNet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02580877