Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

What Was Tested

This registered phase 1 trial tested Glucagon.

The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The study is planned as open, randomised 3-period cross-over in patients with T1DM.

The study will include a total of 6 completing patients.

The study is not blinded due to the exploratory nature.

Who Took Part

Enrollment: 6 planned participants were the target.

It was open to people of any sex aged from 18 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 with diabetes mellitus type 1 , as defined by the American Diabetes Association1. Age ≥ 18 and ≤ 65 years.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; receipt of any investigational medicinal product within 3 months or 5 half-lives of that imp before randomisation in this trial.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

The Glucagon group and the comparison group ran side by side rather than switching.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-08 with completion listed for 2013-11.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: AUCGlucose of different glucagon dosages given s.c.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 6 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.