Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

What Was Tested

The trial (phase 4) is built around 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 two arms (groups): A (experimental) and B (no intervention).

Patients given mixed meal test and blood samples drawn for laboratory testing.

The registry classes the interventions as drug and genetic.

Who Took Part

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

Design: non-randomized, 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 2013-08 with completion listed for 2015-08.

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

What Was Measured

Primary outcome: glycemic control through insulin, glucose, c-peptide and glucagon assays (time frame: duing testing days).

It also tracked 2 secondary outcomes, for example TCF7L2 polymorphism.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized 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It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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.