Feasibility Study of Exenatide by Continuous Subcutaneous Infusion

What Was Tested

This registered phase 1 trial tested Exenatide.

This is an open-label study to investigate the feasibility of administering exenatide by continuous subcutaneous infusion to healthy subjects.

Study will consist of two parts i.e.

In Part A 2 healthy subjects will receive exenatide infusion over 24 hours followed by a follow-up visit 10 to 14 days after discharge from clinic.

It had two arms (groups): Exenatide infusion in Part A (experimental) and Exenatide infusion in Part B (experimental).

Subjects in Part A will receive exenatide as a subcutaneous infusion at a constant rate for 24 hours.

The registry classes the interventions as drug.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male/females aged between 18 and 60 years of age inclusive, at the time of signing the informed consent.

How the Study Was Run

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

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.

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

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

It started in 2013-05-16 with completion listed for 2013-11-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Characterization of interruptions or deviations from prescribed exenatide infusion in Part A (time frame: 2 days). Characterization of interruptions or deviations from prescribed exenatide infusion in Part B (time frame: 8 days). Infusion rate adjustments when nausea/vomiting occurs in Part B (time frame: 8 days).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 10 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, all human trials.