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Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Georgetown University
Sponsor:
Collaborator:
Washington Hospital Center
Information provided by (Responsible Party):
Kim W Hickey, Georgetown University
ClinicalTrials.gov Identifier:
NCT00572689
First received: December 12, 2007
Last updated: August 5, 2013
Last verified: August 2013

December 12, 2007
August 5, 2013
August 2013
June 2015   (final data collection date for primary outcome measure)
glycemic control through insulin, glucose, c-peptide and glucagon assays [ Time Frame: duing testing days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572689 on ClinicalTrials.gov Archive Site
  • TCF7L2 polymorphism [ Time Frame: During subject testing days ] [ Designated as safety issue: No ]
  • Exenatide Pharmacodynamics and Pharmacokinetics [ Time Frame: During testing days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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.
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
13
June 2015
June 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)
Female
18 Years to 50 Years
No
Contact: Patricia Tanjutco, MD 202-877-5811 Patricia.Tanjutco@Medstar.net
Contact: Jason G Umans, MD, PhD 301 560 2959 jason.umans@gmail.com
United States
 
NCT00572689
Exenatide.GDM, 202-801-2636
Yes
Kim W Hickey, 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 2013

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