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Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

NCT00572689 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-08-21

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes

Interventions

DRUG

Exenatide

10 microgram injected sub-cutaneously once

GENETIC

Buccal/blood Sample Collection

Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Jason G Umans, MD, PhD · Georgetown University Medical Center, Medstar Health Research Institute

  • Maisa N Feghali, MD · Medstar Health Research Institute

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572689 on ClinicalTrials.gov