Phase 2 N=92 Randomized Prevention

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

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02580877 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Change in GAD65 Autoantibody Titer (DK Units/mL) — 247; 234; 193; 196 DK Units/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 67.5 mg oral insulin crystals daily (Drug); 500mg oral insulin crystals every other week (Drug)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in GAD65 Autoantibody Titer (DK Units/mL)	247; 234; 193; 196	—
PRIMARY Change in mIAA Autoantibody Titer From Baseline	0.021; 0.020; 0.020; 0.017	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02580877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.