Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

What Was Tested

The trial (phase 2) is built around Glucagon.

Twelve eligible subjects will be randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research center (CRC) visits, followed by the other treatment at the second CRC visit.

Subjects will be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week Outpatient Stage.

It had two arms (groups): Glucagon RTU (glucagon injection) (experimental) and Placebo (placebo comparator).

Non-active vehicle for Glucagon RTU; 60 μL injection.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 14 actual participants took part.

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

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

Examples of who could join: Male or female. Aged 18 to 75 years of age, inclusive. Symptoms of hypoglycemia that developed after bariatric surgery (Roux-en-Y gastric bypass \[RYGB\] only) in the absence of antidiabetic medications. History of bariatric surgery (RYGB only), at least 6 months prior to screening. Ability to both experience and recognize hypoglycemic awareness.

The full record lists 14 inclusion and 21 exclusion criteria; among the exclusions: documented hypoglycemia occurring in the fasting state (\> 12 hours fast) within 12 months of study entry; hypoglycemic unawareness as evidenced by a gold scale score \> 4 at screening; early dumping syndrome.

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.

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

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 2019-05-10 with completion listed for 2020-02-26.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Blood glucose recovery: CRC (time frame: At 15 minutes following administration of study drug). Blood glucose recovery: Out-patient (time frame: At 15 minutes following administration of study drug).

It also tracked 7 secondary outcomes, for example Symptomatic Recovery: CRC, Incidence of severe hypoglycemia: CRC, Incidence of severe hypoglycemia: Out-patient, Incidence of serious hypoglycemia: CRC, Incidence of serious hypoglycemia: Out-patient and Hypoglycemia Fear Scale.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 14 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.