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Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

This study is currently recruiting participants.
Verified November 2011 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: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Gestational Diabetes
 Drug: Exenatide
Genetic: Buccal Sample Collection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Resource links provided by NLM:

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

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • glycemic control through insulin, glucose, c-peptide and glucagon assays [ Time Frame: duing testing days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 13
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Sample Collection
Buccal Sample collection for TCF7L2 polymorphism genetic testing
No Intervention: B
Patients given mixed meal test and blood samples drawn for laboratory testing

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572689

Contacts
Contact: Maisa N Feghali, MD 202 801 4987 maisafeghali@gmail.com
Contact: Jason G Umans, MD, PhD 301 560 2959 jason.umans@gmail.com

Locations
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Maisa N Feghali, MD     202-801-4987     maisafeghali@gmail.com    
Principal Investigator: Jason G Umans, MD, PhD            
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Maisa N Feghali, MD     202-801-4987     maisafeghali@gmail.com    
Principal Investigator: Jason G Umans, MD, PhD            
Sponsors and Collaborators
Georgetown University
Washington Hospital Center
Investigators
Principal Investigator: Jason G Umans, MD, PhD Georgetown University Medical Center, Medstar Health Research Institute
Study Director: Maisa N Feghali, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: Kim W Hickey, Maternal Fetal Medicine specialist - Assistant professor, Georgetown University
ClinicalTrials.gov Identifier: NCT00572689     History of Changes
Other Study ID Numbers: Exenatide.GDM, 202 801 4987
Study First Received: December 12, 2007
Last Updated: November 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Exenatide
TCF7L2 polymorphism
Pharmacodynamics
Pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013