CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
0.4mU Insulin followed by withdrawal period followed by 0.8mU study +1 moredrug
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/NCT04461015
NCT04461015Phase 3Completed
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The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans

Adrian Vella·interventional·Posted Jul 8, 2020·Updated Jun 21, 2022

In Brief

A Phase 3 clinical trial evaluating 0.4mU Insulin followed by withdrawal period followed by 0.8mU study and 0.8mU Insulin followed by withdrawal period followed by 0.4mU study for Healthy. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this research is to help understand the relative importance of changes in insulin secretion (which lowers glucose) and changes in glucagon (which raises glucose) to regulate metabolism and the body's ability to make glucose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJul 8, 2020
Enrollment StartOct 14, 2020
Primary CompletionJul 30, 2021
Study CompletionJan 6, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.0 years ago

Interventions

0.4mU Insulin followed by withdrawal period followed by 0.8mU studydrug

Clamp study with insulin infused at 0.4 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.8 mU/Kg/min

0.8mU Insulin followed by withdrawal period followed by 0.4mU studydrug

Clamp study with insulin infused at 0.8 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.4 mU/Kg/min