Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

NCT00572689 | Withdrawn Phase 4 DMC

• 2 other identifiers: Exenatide.GDM202-801-2636
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes

Keywords

Exenatide; TCF7L2 polymorphism; Pharmacodynamics; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• glycemic control through insulin, glucose, c-peptide and glucagon assays

  duing testing days

Secondary Outcomes (2)

• TCF7L2 polymorphism

  During subject testing days

• Exenatide Pharmacodynamics and Pharmacokinetics

  During testing days

Study Arms (2)

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; Genetic: Buccal/blood Sample Collection

B

NO INTERVENTION

Patients given mixed meal test and blood samples drawn for laboratory testing

Interventions

Exenatide DRUG

10 microgram injected sub-cutaneously once

Also known as: Byetta

A

Buccal/blood Sample Collection GENETIC

Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women (singleton)
• Gestational diabetes not requiring medical therapy
• Between 18 and 50 years of age
• Able to give written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Georgetown University: lead
• Medstar Health Research Institute: collaborator

Study Sites (2)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Jason G Umans, MD, PhD

  Georgetown University Medical Center, Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

• Maisa N Feghali, MD

  Medstar Health Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinipal Investigator

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (2)