Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMaisa N. Feghali, MD

About this trial

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, the investigators 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 the participants' 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, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.

Eligibility criteria

Qualifiers

Pregnant women (singleton)

Gestational diabetes not requiring medical therapy

Between 18 and 50 years of age

Able to give written informed consent

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Exenatide

Treatment groups

13 Participants
are divided into 1 treatment group

Locations

1
Magee Womens Hospital of UPMC15213, PittsburghPennsylvania, United States

Sponsors and collaborators

Maisa N. Feghali, MD

Lead sponsor

University of Pittsburgh

Sponsor institution