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Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
This study is currently recruiting participants.
Verified by Georgetown University, May 2008
First Received: December 12, 2007   Last Updated: May 13, 2008   History of Changes
Sponsors and Collaborators: Georgetown University
Washington Hospital Center
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00572689
  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 IV

MedlinePlus related topics: Diabetes
Drug Information available for: Exenatide
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

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: December 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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
Genetic: Buccal Sample Collection
Buccal Sample collection for TCF7L2 polymorphism genetic testing
B: No Intervention
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 202 415 9162 maisafeghali@gmail.com
Contact: Kimberly W Hickey, MD 202 444 8801 kwhickey@hotmail.com

Locations
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Maisa N Feghali, MD     202-415-9162     maisafeghali@gmail.com    
Principal Investigator: Kimberly W Hickey, MD            
Sub-Investigator: Jason G Umans, MD            
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20001
Contact: Maisa N Feghali, MD     202-415-9162     maisafeghali@gmail.com    
Sub-Investigator: Jason G Umans, MD            
Sub-Investigator: Robert Ratner, MD            
Sponsors and Collaborators
Georgetown University
Washington Hospital Center
Investigators
Principal Investigator: Kimberly W Hickey, MD Georgetown University
Study Chair: Jason G Umans, MD Georgetown University
Study Director: Maisa N Feghali, MD Georgetown University
Study Chair: Robert Ratner, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: Georgetown University Medical Center ( Kimberly W Hickey )
Study ID Numbers: Exenatide.GDM, 202 444 1202
Study First Received: December 12, 2007
Last Updated: May 13, 2008
ClinicalTrials.gov Identifier: NCT00572689     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Exenatide
TCF7L2 polymorphism
Pharmacodynamics
Pharmacokinetics

Study placed in the following topic categories:
Hypoglycemic Agents
Pregnancy Complications
Metabolic Diseases
Exenatide
Diabetes Mellitus
Endocrine System Diseases
Diabetes, Gestational
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

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

ClinicalTrials.gov processed this record on May 07, 2009