Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Condition(s) targeted: Gestational Diabetes

Intervention: Exenatide (Drug); Buccal Sample Collection (Genetic)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Georgetown University

Official(s) and/or principal investigator(s):
Kimberly W Hickey, MD, Principal Investigator, Affiliation: Georgetown University
Jason G Umans, MD, Study Chair, Affiliation: Georgetown University
Maisa N Feghali, MD, Study Director, Affiliation: Georgetown University
Robert Ratner, MD, Study Chair, Affiliation: Washington Hospital Center

Overall contact:
Maisa N Feghali, MD, Phone: 202 415 9162, Email: maisafeghali@gmail.com

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.

Official title: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

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

Primary outcome: glycemic control through insulin, glucose, c-peptide and glucagon assays

Secondary outcome:

TCF7L2 polymorphism

Exenatide Pharmacodynamics and Pharmacokinetics

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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)

Maisa N Feghali, MD, Phone: 202 415 9162, Email: maisafeghali@gmail.com

Georgetown University Medical Center, Washington, District of Columbia 20007, United States

Washington Hospital Center, Washington, District of Columbia 20001, United States

Starting date: December 2009
Ending date: August 2010
Last updated: August 10, 2009