New Onset Type 1 Diabetes: Role of Exenatide

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

It had four arms (groups): Part A (experimental), Part B (active comparator), Part C (active comparator) and Healthy controls (no intervention).

Exenatide and long acting insulin before the boost.

Rapid and long acting insulin before the boost.

The registry classes the interventions as drug.

More on the Plan

The specific aims of this study are to determine the following: 1.

The role of exenatide on postprandial glucagon and gastric emptying. 3.

The effect of long acting insulin on postprandial glucose excursions, glucagon concentrations and gastric emptying. 4.

Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 12 years up to 18 years.

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

Examples of who could join: Age between 12-18 years of age at the time of enrollment. Diagnosed with antibody positive T1DM in the past 3 months. Otherwise healthy except for their TIDM and treated hypothyroidism. Females must have a negative pregnancy test. Weight greater than 44 kg.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: any medications that may affect glucose metabolism; abnormal ast, alt, amylase, lipase, creatinine (more than 3 times normal values); lack of a supportive family environment as detected by the clinicians and/or social workers.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

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

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2010-12 with completion listed for 2017-01-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example The Role of Exenatide on Postprandial Glucagon and Gastric Emptying and Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 13 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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