Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses

What Was Tested

In this phase 2 trial, researchers set out to test Glucagon.

This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo.

After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure.

Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo.

It had four arms (groups): CSGI high infusion rate (experimental), CSGI low infusion rate (experimental), Placebo high infusion rate (placebo comparator) and Placebo low infusion rate (placebo comparator).

Glucagon given as a continuous subcutaneous infusion for 28 days.

Glucagon given as a continuous subcutaneous infusion for 28 days.

Placebo given as a continuous subcutaneous infusion for 28 days.

The registry classes the interventions as drug.

Who Took Part

49 actual participants took part.

It was open to people of any sex aged from 21 years up to 64 years.

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

Examples of who could join: Males or females diagnosed with type 1 diabetes mellitus for at least 24 months. Random serum C-peptide concentration \< 0.5 ng/ml at Screening. Performs monitoring of glucose minimally 3 times a day. Patients using continuous glucose monitoring for monitoring should continue to do so during the course of the study. Age 21-64 years, inclusive, at screening. Willingness to provide informed consent and follow all study procedures, including using the Medtronic smart phone application "iPRO2mylog" for diabetes data logging and attending all scheduled visits.

The full record lists 7 inclusion and 26 exclusion criteria; among the exclusions: subjects using csii, who do not use a medtronic pump; chronic kidney disease stage 4 or 5; blood pressure (bp) reading at screening where systolic bp \<90 or \>150 mm hg, or diastolic bp \<50 or \>100 mm hg.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2018-03-15 with completion listed for 2019-11-04.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Plasma Epinephrine (time frame: 0-30 minutes).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 49 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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