Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

NCT00572689 · Withdrawn

Last updated 2026-05-28

This clinical trial is testing how a diabetes medication called exenatide affects blood sugar levels in pregnant women with gestational diabetes.

Status Withdrawn Stopped before any participant enrolled.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) study

Who can join Ages 18–50 · female only

Timeline Started 2013-08 · est. completion 2015-08

Where 2 sites · United States

What this study is testing ClinicalTrials.gov NCT00572689 ↗

Description as written by the study sponsor.

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. To do this, we will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps your pancreas secrete insulin and how well it controls blood sugar after a meal). 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. Therefore, we hope to find out if exenatide might also be helpful in gestational diabetes.

Treatments tested

Exenatide also known as Byetta Drug

10 microgram injected sub-cutaneously once
Buccal/blood Sample Collection Genetic

Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

Main thing measured	glycemic control through insulin, glucose, c-peptide and glucagon assays
Sponsor	Georgetown University
Conditions studied	Gestational Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00572689 ↗