At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 92 enrolled
Drug / intervention
67.5 mg oral insulin crystals daily +1 moredrug
Likely dose
67.5 mg oral insulin crystals dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Oct 20, 2015·Updated Jul 27, 2020
In Brief
A Phase 2 clinical trial evaluating 67.5 mg oral insulin crystals daily and 500mg oral insulin crystals every other week for Type 1 Diabetes. Completed, enrolled 92 participants across 19 sites in 4 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesAustralia, Canada, Italy, United States
CollaboratorsType 1 Diabetes TrialNet
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartJan 2016
Primary CompletionMar 2018
TodayJul 2026
First PostedOct 20, 2015
Enrollment StartJan 1, 2016
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.7 years ago
Interventions
67.5 mg oral insulin crystals dailydrug
human insulin crystals in capsules
500mg oral insulin crystals every other weekdrug
human insulin crystals in capsules