Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00572689
• Other study ID #: Exenatide.GDM
• Secondary ID: 202-801-2636
• Status: Withdrawn
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: August 20, 2015
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• Exenatide
10 microgram injected sub-cutaneously once

Genetic:
• Buccal/blood Sample Collection
Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Washington Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control through insulin, glucose, c-peptide and glucagon assays		duing testing days	No
Secondary	TCF7L2 polymorphism		During subject testing days	No
Secondary	Exenatide Pharmacodynamics and Pharmacokinetics		During testing days	No