Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide and Insulin (regular human).

It had three arms (groups): Pramlintide + Insulin Group (experimental), Exenatide + Insulin Group (experimental) and Insulin monotherapy (active comparator).

These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.

This group will get Exenatide(Byetta) along with insulin before breakfast and supper.

This group will be on their regular insulin therapy.

The registry classes the interventions as drug.

More on the Plan

After signing an informed consent, prior to study enrollment, a screening evaluation will be performed in the Clinical Research Center (CRC).

The evaluation will consist of: a medical history, a physical examination with vital signs, Tanner staging, and a waist circumference.

The following laboratory tests will be done: CBC, HbA1c, creatinine,Liver function tests, amylase, lipid profile, lipase, urine for pregnancy test (when appropriate) and microalbumin.

A urine pregnancy test will be done at each study visit in menstruating females.

Who Took Part

Enrollment: 37 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: Age of 12 to 21 years. Subjects must be on intensive insulin management. Tanner stage greater than or equal to 3. Willing to give consent.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: having any other chronic condition except hypothyroidism stable on medications; on chronic medications that may affect glucose excursions; anemia as defined as hb less than 9 gm/dl.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2009-08 with completion listed for 2016-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Difference in HbA1C Between the Treatment and the Control Groups.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin (regular human) in 37 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.