Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass

What Was Tested

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

The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.

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

The registry classes the interventions as drug and other.

More on the Plan

However, several RYGB-individuals, post surgery, suffers from dumping syndrome and postprandial hyperinsulinemic hypoglycemia (PHH) due to the anatomical rearrangement of the gastro-intestinal system.

The study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days in which participants will undergo an MMT along with one of the following double-blinded interventions: 1.

Subcutaneous (sc) placebo (saline) injection 2.

Who Took Part

The registry lists 10 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 8 inclusion and 8 exclusion criteria; among the exclusions: treatment with medication(s) affecting insulin secretion 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.

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

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Glucagon.

Those kept unaware of assignments: participant and investigator.

It started in 2019-09-18 with completion listed for 2020-02-26.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Nadir plasma glucose concentration within two hundred forty minutes after MMT (time frame: Two hundred forty minutes).

It also tracked 8 secondary outcomes, for example Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level, Time below fasting plasma glucose level from study drug administration until two hundred forty minutes, The Dumping Severity Score (DSS) and Frequency and severity of adverse events and serious adverse events recorded during the meal test.

What This Means in Plain Language

Put simply, this is a phase 2, 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.