Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Phase 4

Withdrawn

• Conditions: Gestational Diabetes
• Interventions: Drug: Exenatide; Genetic: Buccal/blood Sample Collection

• Registration Number: NCT00572689
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Study Start: 2013-08
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Buccal/blood Sample Collection	Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
A	Exenatide	Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
TCF7L2 polymorphism	During subject testing days
Exenatide Pharmacodynamics and Pharmacokinetics	During testing days

Trial Locations

Locations (2)

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States