Effect of C-peptide on Hypoglycemic Counterregulation

What Was Tested

In this early phase 1 trial, researchers set out to test C-Peptide.

It had four arms (groups): Healthy Control- Saline (placebo comparator), Healthy Control- C-peptide (active comparator), T1D- Saline (placebo comparator) and T1D- C-peptide (active comparator).

Saline will be infused in healthy control subjects during insulin-induced hypoglycemia.

C-peptide will be infused in healthy control subjects during insulin-induced hypoglycemia.

Saline will be infused in T1D subjects during insulin-induced hypoglycemia.

The registry classes the interventions as biological and other.

More on the Plan

In previous experiments in the dog, the researchers observed that C-peptide infusion augmented glucagon secretion and hepatic glucose production during insulin-induced hypoglycemia.

The proposed experiments will determine the translational impact of this finding in patients with and without T1D.

Specific Aim #1 is to determine, in healthy control subjects, the effect of C-peptide co-infusion with insulin on endogenous glucose production (EGP) and counterregulatory hormone levels during hypoglycemia.

This will be addressed by studying a single group of healthy subjects two times.

Who Took Part

The registry lists 38 planned participants were the target.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI less than 30 kg/m2.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: pregnant or lactating women cigarette smoking presence of hiv or hepatitis presence of cardiovascular disease presence of microvascular disease.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got C-Peptide and who got the comparison, which limits bias.

Each person switched between C-Peptide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on C-Peptide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-06-01 with completion listed for 2027-06-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Glucagon (time frame: During procedure, up to 2.5 hours).

It also tracked 2 secondary outcomes, for example Hepatic glucose production and Liver glycogen.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of C-Peptide in 38 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the C-Peptide compound page, all human trials.