Glucagon Counterregulation in Type 1 Diabetes

What Was Tested

This registered not phased trial tested Amylin (Islet Amyloid Polypeptide).

The purpose of this study is to find out whether the combination of insulin and pramlintide is better than insulin alone at helping the pancreas release glucagon in response to a low blood sugar episode.

A secondary goal is to assess whether basal pramlintide will delay gastric emptying.

It had four arms (groups): Insulin hypoglycemia + pramlintide (experimental), Insulin hypoglycemia (active comparator), Exercise hypoglycemia + pramlintide (experimental) and Exercise hypoglycemia (active comparator).

The registry classes the interventions as other.

More on the Plan

The two overnight visits will last about 22 hours.

During the CRU admission, all subjects will wear a Continuous Glucose Monitor (CGM) starting 2-3 days prior to the CRU admission and after having a CGM training.

Eligible subjects will be randomized to either insulin- or exercise-induced hypoglycemia group.

The study team will collect blood samples during the hypoglycemic induction and the gastric emptying monitoring which will be analysed for levels of various substances used to address the study goals.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 21 years up to 55 years.

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

Examples of who could join: Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 5 years and using insulin for at least 5 years. Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: admission for diabetic ketoacidosis in the 6 months prior to enrollment; severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment; hematocrit less that the lower limit of normal for the assay.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Amylin (Islet Amyloid Polypeptide) study: the participants and staff both knew the treatment.

It started in 2018-05-20 with completion listed for 2019-03-11.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Relative glucagon counterregulation (GCR) response (time frame: about 19 hours).

It also tracked 2 secondary outcomes, for example Maximal glucagon counterregulation (GCR) response and Rate of gastric emptying.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 13 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.