Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00572689

Enrollment

Registered

2007-12-13

Start date

2013-08-31

Completion date

2015-08-31

Last updated

2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Exenatide, TCF7L2 polymorphism, Pharmacodynamics, Pharmacokinetics

Brief summary

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.

Interventions

DRUGExenatide

10 microgram injected sub-cutaneously once

GENETICBuccal/blood Sample Collection

Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Pregnant women (singleton) * Gestational diabetes not requiring medical therapy * Between 18 and 50 years of age * Able to give written informed consent

Exclusion criteria

* Women in the first trimester of pregnancy * Hematocrit less than 30% * 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. * Women with high triglyceride levels, history of gallbladder or pancreatic disease. * Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)

Design outcomes

Primary

Measure	Time frame
glycemic control through insulin, glucose, c-peptide and glucagon assays	duing testing days

Secondary

Measure	Time frame
TCF7L2 polymorphism	During subject testing days
Exenatide Pharmacodynamics and Pharmacokinetics	During testing days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026