Physiologic Response to Glucagon at Varying Insulin Levels

What Was Tested

This registered not phased trial tested Insulin (regular human) and Glucagon.

Insulin is a hormone that lowers blood glucose.

It had six arms (groups): Low, Medium and High insulin infusion (experimental), Low, High and Medium insulin infusion (experimental), Medium, Low and High insulin infusion (experimental), Medium, High and Low insulin infusion (experimental) and High, Low and Medium insulin infusion (experimental).

All study subjects in this arm were randomized as follows: First study is regular insulin infused at lowest level with glucagon administration. Second study is regular insulin infused at medium level with glucagon adminstration. Third study is regular insulin infused at highest level with glucagon administration.

All study subjects in this arm were randomized as follows: First study is regular insulin infused at lowest level with glucagon administration. Second study is regular insulin infused at highest level with glucagon adminstration. Third study is regular insulin infused at medium level with glucagon administration.

All study subjects in this arm were randomized as follows: First study is regular insulin infused at medium level with glucagon administration. Second study is regular insulin infused at lowest level with glucagon adminstration. Third study is regular insulin infused at highest level with glucagon administration.

The registry classes the interventions as drug.

More on the Plan

This study is designed to address this question.

On each study day, there will be a continuous infusion of a different rate of IV Regular insulin in order to achieve different steady state free insulin levels.

Octreotide will be infused by IV at a constant rate to suppress endogenous production of glucagon.

A stable glucose isotope will also be infused to allow for measurement of hepatic glucose production and glucose turnover.

Who Took Part

The registry lists 11 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female subjects 21 to 65 years of age. Current use of an insulin pump. Willingness to sign informed consent and HIPAA documents and follow all study procedures.

The full record lists 4 inclusion and 23 exclusion criteria; among the exclusions: adrenal insufficiency; A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence; congestive heart failure, nyha class iii or iv.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2011-11 with completion listed for 2013-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Area Under the Curve for Glucose Above Baseline (time frame: 60 minutes after each glucagon administration).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Glucagon in 11 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Glucagon compound page, all human trials.