Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

What Was Tested

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

It had six arms (groups): Sequence 1 (experimental), Sequence 2 (experimental), Sequence 3 (experimental), Sequence 4 (experimental) and Sequence 5 (experimental).

The registry classes the interventions as drug.

Who Took Part

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: Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening. Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates. Body mass index (BMI) ≤ 40 kg/m2.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: history of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients; history of insulinoma, pheochromocytoma, men 2a, men 2b, neurofibromatosis, or von hippel-lindau disease; hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (uln).

How the Study Was Run

It was run as a randomized, crossover and quadruple-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, care provider, investigator and outcomes assessor.

It started in 2023-02 with completion listed for 2023-02.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Nadir plasma glucose concentration (time frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test).

It also tracked 4 secondary outcomes, for example Percent time spent in hypoglycemia, Percent time spent in target range and Percent time spent in hyperglycemia.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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