Official Title: “Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes”

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.

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Exenatide
  • 10 microgram injected sub-cutaneously once
• Genetic: Buccal Sample Collection
  • Buccal Sample collection for TCF7L2 polymorphism genetic testing

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
• No Intervention: B
  • Patients given mixed meal test and blood samples drawn for laboratory testing

Primary Measures

• glycemic control through insulin, glucose, c-peptide and glucagon assays
  • Time Frame: duing testing days
    Safety Issue?: No

Secondary Measures

• TCF7L2 polymorphism
  • Time Frame: During subject testing days
    Safety Issue?: No
• Exenatide Pharmacodynamics and Pharmacokinetics
  • Time Frame: During testing days
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Georgetown University

Overall Clinical Trial Officials and Contacts

Kimberly W Hickey, MD Principal Investigator Georgetown University  

Overall Contact: Maisa N Feghali, MD 202 415 9162 maisafeghali@gmail.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00572689

Study ID Number: Exenatide.GDM

ClinicalTrials.gov Identifier: NCT00572689

Health Authority: United States: Institutional Review Board