Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes



Status:Withdrawn
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:August 2013
End Date:August 2015

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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.


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)
We found this trial at
2
sites
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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