NCT04461015

The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans

Completed Phase 3 Results posted Last updated 21 June 2022

What this trial tests

Phase 3 trial testing 0.4mU Insulin followed by withdrawal period followed by 0.8mU study in Healthy in 12 participants. Completed in 6 January 2022.

Timeline

14 October 2020

Primary endpoint
30 July 2021

6 January 2022

Quick facts

Lead sponsor	Adrian Vella
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	14 October 2020
Primary completion	30 July 2021
Estimated completion	6 January 2022
Sites	1 location across United States

Drugs / interventions tested

• 0.4mU Insulin followed by withdrawal period followed by 0.8mU study — full drug profile →
• 0.8mU Insulin followed by withdrawal period followed by 0.4mU study — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Adrian Vella — full company profile →

Who can join

Adults 18 to 40, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Endogenous Glucose Production (EGP) Primary · It will be quantified at 90, 180 and 270 minutes for the study with 0.4mU insulin infusion and compared to values obtained for the study with 0.8mU insulin infusion at the same timepoints

is calculated by tracer-based measurement and expressed per kg lean body mass

At 90 minutes

Group	Value	95% CI
0.4mU Insulin	4.99	± 0.53
0.8mU Insulin	5.02	± 0.74

At 180 minutes

Group	Value	95% CI
0.4mU Insulin	6.82	± 0.82
0.8mU Insulin	5.52	± 0.96

At 270 minutes

Group	Value	95% CI
0.4mU Insulin	8.48	± 1.07
0.8mU Insulin	5.38	± 1.13

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

0.4 Events

Serious: 0/12 (0%)

Deaths: 0/12

0.8 Events

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (2 terms — click to expand)

Reaction	System	0.4 Events	0.8 Events
Phlebitis	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04461015 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.