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

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

November 1, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00572689 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Official Title ^ICMJE

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Gestational Diabetes

Intervention ^ICMJE

Drug: Exenatide
10 microgram injected sub-cutaneously once

Other Name: Byetta
Genetic: Buccal Sample Collection
Buccal Sample collection for TCF7L2 polymorphism genetic testing

Study Arm (s)

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 Sample Collection
No Intervention: B
Patients given mixed meal test and blood samples drawn for laboratory testing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00572689

Other Study ID Numbers ^ICMJE

Exenatide.GDM, 202 801 4987

Has Data Monitoring Committee

Yes

Responsible Party

Kim W Hickey, Georgetown University

Study Sponsor ^ICMJE

Georgetown University

Collaborators ^ICMJE

Washington Hospital Center

Investigators ^ICMJE

Principal Investigator:	Jason G Umans, MD, PhD	Georgetown University Medical Center, Medstar Health Research Institute
Study Director:	Maisa N Feghali, MD	Washington Hospital Center

Information Provided By

Georgetown University

Verification Date

November 2011

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

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