The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Subjects With and Without Type 1 Diabetes

What Was Tested

This registered not phased trial tested GIP (Gastric Inhibitory Polypeptide).

The hormone glucose-dependent insulinotropic polypeptide (GIP) is naturally produced in the intestine during a meal and stimulates insulin secretion from the pancreas.

Insulin ensures that nutrients from the meal are transported from the blood into the cells, allowing the body to use it as energy.

If blood sugar levels drop too much, the body naturally releases another hormone: glucagon.

It had four arms (groups): GIP (active comparator), Alanine (active comparator), GIP + Alanine (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to men only aged from 18 years up to 70 years.

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

Examples of who could join: Age between 18 and 70 years. Body mass index between 20-27 kg/m2. T1D duration of 2-20 years. Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months. Informed and written consent.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: anaemia (haemoglobin below normal range); late microvascular complications except mild nonproliferative retinopathy; liver disease (alanine aminotransferase (alat) and/or aspartate aminotransferase (asat) \>2 times normal values) or history of hepatobiliary disorder.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this GIP (Gastric Inhibitory Polypeptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both GIP (Gastric Inhibitory Polypeptide) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on GIP (Gastric Inhibitory Polypeptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2025-01-01 with completion listed for 2026-01-16.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: bsAUC of glucagon concentration (time frame: From 0-150 minutes).

It also tracked 2 secondary outcomes, for example bsAUC Glucagon 30-90 and bsAUC glucagon 90-150 min.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of GIP (Gastric Inhibitory Polypeptide) 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 GIP (Gastric Inhibitory Polypeptide) compound page, all human trials.