Study of Exenatide Once-Weekly Suspension in Chinese Patients With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Exenatide.

It had 1 arm (groups): Single arm of exenatide once-weekly suspension (experimental).

Exenatide once-weekly suspension via subcutaneous (SC) injection.

The registry classes the interventions as drug.

More on the Plan

Up to 30 patients may initially be enrolled to target at least 20 patients completing the study.

Follow-up observations will be conducted at Visits 22 to 29 (Weeks 15 to 26), with the final follow-up at/after Visit 29 (Week 26 ±2 days).

During follow-up period, Blood samples will be collected for PK analyses.

Subjects will be monitored closely for adverse events throughout the study.

Who Took Part

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Provision of informed consent prior to any study-specific procedures. Between 20 to 75 years of age inclusive at Visit 1 (Screening). The following criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only:. Test negative for pregnancy at the time of screening. Intend not to become pregnant during the study.

The full record lists 12 inclusion and 32 exclusion criteria; among the exclusions: previous enrollment in the present study or have previously completed or withdrawn from any other study investigating exenatide; known allergy or hypersensitivity to exenatide or any of the excipients contained in these agents (exenatide: sodium acetate buffer, mannitol, metacresol, mct vehicle); previous treatment with exenatide or related glp-1 receptor agonist compounds.

How the Study Was Run

It was run as a single-group and open-label study.

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

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

It started in 2020-06-30 with completion listed for 2021-07-02.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Plasma concentrations versus time profile of exenatide. Cmax. tmax.

It also tracked 11 secondary outcomes, for example Electrocardiograms (ECGs), Blood pressure (BP), Pulse rate, Body temperature, Safety and tolerability as determined by abnormality in clinical chemistry compared to baseline and Safety and tolerability as determined by abnormality in hematology compared to baseline.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.