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Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

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ClinicalTrials.gov 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Recruitment Status : Withdrawn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

Brief 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Drug: Exenatide Genetic: Buccal/blood Sample Collection Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Study Start Date : August 2013
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arm Intervention/treatment
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
10 microgram injected sub-cutaneously once
Other Name: Byetta
Genetic: Buccal/blood Sample Collection
Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing
No Intervention: B
Patients given mixed meal test and blood samples drawn for laboratory testing

Primary Outcome Measures :
  1. glycemic control through insulin, glucose, c-peptide and glucagon assays [ Time Frame: duing testing days ]

Secondary Outcome Measures :
  1. TCF7L2 polymorphism [ Time Frame: During subject testing days ]
  2. Exenatide Pharmacodynamics and Pharmacokinetics [ Time Frame: During testing days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572689

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
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

Responsible Party: Jason Umans, Prinipal Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT00572689     History of Changes
Other Study ID Numbers: Exenatide.GDM
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Keywords provided by Jason Umans, Georgetown University:
TCF7L2 polymorphism

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists