A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

It had two arms (groups): Placebo (placebo comparator) and Exenatide (Bydureon) (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a multi-site randomized placebo controlled trial of Bydureon in patients with type I diabetes (T1D) of at least 2 years duration who may or may not still have detectable levels of C-peptide during a mixed meal tolerance test (MMTT).

Bydureon is a recently approved long acting form of Exenatide.

Because of the lack of safety data for Bydureon in children, the researchers propose to conduct the trial in adults (\>18 yrs.).

Both the subject and the study personnel will be blinded to treatment assignment.

Who Took Part

79 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria. Diagnosis of T1DM at least 2 years from Visit 0. Absence of ketoacidosis in the past 6 months. Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period. Signed informed consent.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: inability or unwillingness to give informed consent; current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status; known hypersensitivity to exenatide, liraglutide or any product component.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

The Exenatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2013-09 with completion listed for 2018-06.

It ran at 8 sites in United States (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c Levels (time frame: 6 months).

It also tracked 3 secondary outcomes, for example Change From Baseline in HbA1c Levels, Major Hypoglycemic Event Rate On Drug and Major Hypoglycemic Event Rate Off Drug.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 79 people.

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.