The Role of Amylin and Glucagon in T1DM

What Was Tested

This registered phase 3 trial tested Glucagon and Amylin (Islet Amyloid Polypeptide).

The studies outlined in this proposal might help in developing new treatment options to target "after meal" high blood sugar and before meal low blood sugar in children.

The registry classes the interventions as drug.

More on the Plan

Description of Project: In health individuals, "after meal" blood sugar level is very carefully controlled.

Insulin (the hormone that lowers blood sugar) and glucagon (the hormone that raises blood sugar) play a key role in maintaining this careful balance.

Recently the researchers understand that a hormone called amylin also contributes to this careful after meal blood glucose balance.

In T1DM, there is the lack of insulin and failure of glucagon suppression leading to hyperglycemia immediately following when food is eaten.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 12 years up to 21 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age \>12 years \< 19 years. Be on continuous subcutaneous insulin infusion using an insulin pump. Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism. Menstruating women must have negative pregnancy test. Weight more than 44 kg.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: age \>18 or \< 12 y at the time of study; lack of a supportive family environment; positive pregnancy test in menstruating young women.

How the Study Was Run

The set-up was randomized, single-group and open-label.

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

Being open-label, the Glucagon study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2002-07 with completion listed for 2005-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the curve for glucose.

It also tracked 1 secondary outcome, for example Glucagon and gastric emptying.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon and Amylin (Islet Amyloid Polypeptide) in 30 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 and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.