The Effect of Glycemic Control and of GLP-1 Receptor Agonism on Islet GLP-1 in People With Type 1 and Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Liraglutide.

However, its regulation is at present unknown.

It had four arms (groups): Type 1 diabetes - Placebo arm (placebo comparator), Type 1 diabetes - Liraglutide arm (active comparator), Type 2 diabetes - Placebo arm (placebo comparator) and Type 2 diabetes - Liraglutide arm (active comparator).

Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase.

Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase.

The registry classes the interventions as drug and other.

More on the Plan

This supports other evidence (rodents and humans) that through the (inducible) expression of a prohormone convertase (PC-1/3), the α-cell can process proglucagon to intact GLP-15,6. 'Islet' or 'pancreatic' GLP-1 acts in a paracrine fashion to regulate insulin (basal and 1st phase) and glucagon secretion.

This is a testable hypothesis in humans; people with type 1 diabetes (T1DM) have dysregulated glucagon secretion and evidence of islet GLP-1.

It is unclear if the effects of GLP1R agonism on islet GLP-1 differ compared to T2DM.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 25 years up to 70 years.

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

Examples of who could join: Type 1 or type 2 diabetes treated with insulin.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: age \< 25 or \> 70 years; for female subjects: positive pregnancy test at the time of enrollment or study; history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Only one side, usually the participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: participant.

It started in 2025-10-03 with completion listed for 2028-10-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Effect of exendin 9-39 on fasting glucagon secretion rate before and after liraglutide treatment. Effect of exendin 9-39 on glucagon secretion rate during hyperglycemia before and after liraglutide.

It also tracked 2 secondary outcomes, for example Effect of exendin 9-39 on fasting glucagon secretion rate in people with type 1 diabetes vs type 2 diabetes and Effect of exendin 9-39 on glucagon secretion rate during hyperglycemia in people with type 1 diabetes vs type 2 diabetes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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