Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women.

There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects.

It had 1 arm (groups): Exenatide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 13 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Pregnant women (singleton). Gestational diabetes not requiring medical therapy. Between 18 and 50 years of age. Able to give written informed consent.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: women in the first trimester of pregnancy; current or past treatment with any hypoglycemic agent; women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment.

How the Study Was Run

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

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 2023-04-12 with completion listed for 2025-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose (time frame: Baseline and 1 week later).

It also tracked 1 secondary outcome, for example Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Exenatide in 13 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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