Role of Exenatide in Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Exenatide and Insulin (regular human).

The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal.

This study may help in developing new treatments to help control high blood sugars after meals.

It had three arms (groups): one (experimental), one (experimental) and Insulin (active comparator).

Each subject received a baseline study with insulin alone.

The registry classes the interventions as drug.

More on the Plan

In people without diabetes, the "after meal" blood sugar level is very carefully controlled.

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

It is now known that a substance made by the body called GLP-1 also helps with this careful balance.

Glucagon like peptide-1 works in four ways.

Who Took Part

The registry lists 11 actual participants took part.

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

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

Examples of who could join: Between 12-21 years of age at the time of enrollment. Menstruating women must have a negative pregnancy test. Weight greater than 44 kg. Tanner stage greater than 3.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: lack of a supportive family environment as detected by the clinicians and/or social workers; positive pregnancy test in menstruating young women; BMI greater than 90th percentile for age or less than 10th percentile for age.

How the Study Was Run

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

Because people in this Exenatide 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 Exenatide and the comparison in turn, acting as their own control.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2007-03 with completion listed for 2009-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide [amount hidden] or Exenatide [amount hidden] Treated Groups Along With Insulin, Compared to Insulin Alone.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide and Insulin (regular human) in 11 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 and the Insulin (regular human) compound page, all human trials.