CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Ultra-rapid insulindrug
Likely dose
Not stated in 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.

Search/NCT04416737
NCT04416737Phase 1Completed

Evaluating the Benefits of Physiologic Insulin Delivery

Stanford University·interventional·Posted Jun 4, 2020·Updated Oct 1, 2024

In Brief

A Phase 1 clinical trial evaluating Ultra-rapid insulin for Type 1 Diabetes. Completed, enrolled 16 participants across 1 site.

Detailed Summary

In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. We will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJun 4, 2020
Enrollment StartNov 1, 2021
Primary CompletionJun 2, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.1 years ago

Interventions

Ultra-rapid insulindrug

Following 0.5-3 hours of insulin suspension from insulin pump, participants will receive insulin injection in respective locations (separated by at least 1 week) and then have serial lab measurements (YSI glucose, insulin and glucagon) taken during induced hypoglycemia.