Autoinjector Device Assessment Study

What Was Tested

In this phase 1 trial, researchers set out to test Exenatide.

Phase I study to determine the device-related injection failure rate of the single-use, pre-filled autoinjector.

It had five arms (groups): Arm 1 (experimental), Arm 2 (experimental), Arm 3 (experimental), Arm 4 (experimental) and Arm 5 (experimental).

The registry classes the interventions as drug.

More on the Plan

Phase I multi-cohort study will employ a flexible study design to accommodate multiple cohorts.

Injection failure rates will be continually assessed.

Injection pain will also be assessed.

Who Took Part

3052 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Is at least 18 years old at Visit 1 (Screening). Subjects must be of legal age of consent. Has body mass index of 22 kg/m2 to 45 kg/m2, inclusive, at Visit 1 (Screening). Is male, or is female and meets all the following criteria:. Negative pregnancy test result (human chorionic gonadotropin, beta subunit \[bhCG\]) at Visit 1 (Screening).

The full record lists 11 inclusion and 23 exclusion criteria; among the exclusions: history of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations; presence of medullary carcinoma or multiple endocrine neoplasia (men ii) or a family history of medullary carcinoma or men ii; organ transplantation.

How the Study Was Run

The set-up was randomized, parallel-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.

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-02 with completion listed for 2013-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of device-related failure injections (time frame: 10 week study).

It also tracked 1 secondary outcome, for example Number of device-related injection failures of alternate device configuration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 3052 people.

With 3052 participants it is a large trial for this field.

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.