A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Very Low Dose-Glucagon in Subjects With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Glucagon.

The registry classes the interventions as drug.

More on the Plan

Glucagon is currently used to treat severe hypoglycemia.

Who Took Part

10 planned participants were the target.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Males or females, 18 to 55 years of age, requiring daily insulin for the management of type 1 diabetes mellitus for \>10 years. Normal thyroid stimulating hormone. No history of HIV infection and negative results for hepatitis B and C. Negative serum pregnancy test, non-lactating, and using adequate contraception, if female and of child bearing potential (intact uterus and pre-menopausal). Medications for the treatment of high blood pressure and/or dyslipidemia are allowed if regimen stable for 2 months prior to screening.

The full record lists 15 inclusion and 7 exclusion criteria; among the exclusions: participation in a clinical trial with or use of an investigational agent within 30 days of study visit 1; history of atherosclerosis including coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident, or transient ischemic attacks; history or symptoms of pheochromocytoma.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

It started in 2006-03 with completion listed for 2006-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 10 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.