Treatment of Post-bariatric Hypoglycaemia

What Was Tested

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

The study is divided into an in-patient and out-patient part.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Subcutaneous placebo self-administration.

The registry classes the interventions as device and drug.

More on the Plan

After enrolment in the study, the participants will wear a CGM for the entirety of the study period (apart from the four weeks before the follow-up visit).

During the in-patient part, the participants will undergo two separate MMTs, with a minimum of 7 days in-between, accompanied by one of the following double-blind, randomised, placebo-controlled crossover interventions: 1.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Normal electrocardiogram (ECG). Negative urine human chorionic gonadotropin (hCG) (for fertile women).

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: treatment with medication(s) affecting insulin secretion, glucose metabolism or any antidiabetic drugs; treatment with antipsychotics; current participation in another clinical trial with administration of investigational drug.

How the Study Was Run

It was run as a randomized, crossover 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.

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

As a double-blind Glucagon study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-08-20 with completion listed for 2022-05-15.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time spent in hypoglycaemia (IG < [amount hidden]).

It also tracked 24 secondary outcomes, for example Glycaemic variability assessed as coefficient of variance (CV), Glycaemic variability assessed as standard deviation (SD), Change in QoL as assessed by the World Health Organization's quality of life assessment (WHOQOL-BREF), Change in hypoglycaemic symptoms will be evaluated by Edinburgh Hypoglycaemia Symptom Scale (EHSS), Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale (HFS-II) and Change in administration frequency (as measured by percentage).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 24 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.