Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572689
Recruitment Status : Withdrawn
First Posted : December 13, 2007
Last Update Posted : August 21, 2015
Washington Hospital Center
Information provided by (Responsible Party):
Jason Umans, Georgetown University

December 12, 2007
December 13, 2007
August 21, 2015
August 2013
August 2015   (Final data collection date for primary outcome measure)
glycemic control through insulin, glucose, c-peptide and glucagon assays [ Time Frame: duing testing days ]
Same as current
Complete list of historical versions of study NCT00572689 on Archive Site
  • TCF7L2 polymorphism [ Time Frame: During subject testing days ]
  • Exenatide Pharmacodynamics and Pharmacokinetics [ Time Frame: During testing days ]
Same as current
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Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
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.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Gestational Diabetes
  • Drug: Exenatide
    10 microgram injected sub-cutaneously once
    Other Name: Byetta
  • Genetic: Buccal/blood Sample Collection
    Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing
  • 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.
    • Drug: Exenatide
    • Genetic: Buccal/blood Sample Collection
  • No Intervention: B
    Patients given mixed meal test and blood samples drawn for laboratory testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2015
August 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Jason Umans, Georgetown University
Georgetown University
Washington Hospital Center
Principal Investigator: Jason G Umans, MD, PhD Georgetown University Medical Center, Medstar Health Research Institute
Study Director: Maisa N Feghali, MD Washington Hospital Center
Georgetown University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP