The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide and Amylin (Islet Amyloid Polypeptide).

The purpose of this study is to see if giving study drugs before a meal may lower blood sugars after the meal.

It had two arms (groups): exenatide (active comparator) and pramlintide (active comparator).

The registry classes the interventions as drug.

More on the Plan

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

Also, the researchers now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance.

Amylin is made in the pancreas.

GLP-1 is made in the gut.

Who Took Part

The registry lists 16 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 the ages of 12-21 years,. Tanner stage 4-5 for pubertal development,. Menstruating females must have a negative urine pregnancy test for inclusion,. Must have T2DM for at least 6 months,. History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell antibodies,.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: BMI\> 40 kg/m2,; weight of \< 60 kg,; female with menstrual irregularities,.

How the Study Was Run

The set-up was randomized, single-group and single-blind.

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

Only one side, usually the participants, was kept unaware of whether Exenatide was given.

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

Those kept unaware of assignments: participant.

It started in 2009-07 with completion listed for 2011-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glucose (time frame: 4 hours).

It also tracked 4 secondary outcomes, for example glucagon, gastric emptying, pramlintide concentrations and exenatide concentrations.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Amylin (Islet Amyloid Polypeptide) in 16 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 Exenatide compound page and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.