Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes - Full Text View

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:	Other, 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

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

Keywords provided by Georgetown University:

Exenatide

TCF7L2 polymorphism

Pharmacodynamics

Pharmacokinetics

Study placed in the following topic categories:

Pregnancy Complications

Metabolic Diseases

Exenatide

Diabetes Mellitus

Endocrine System Diseases

Diabetes, Gestational

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	Georgetown University Washington Hospital Center
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00572689