Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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, 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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Pregnant women (singleton)

• Gestational diabetes not requiring medical therapy

• Between 18 and 50 years of age

• Able to give written informed consent

Locations
United States
Pennsylvania
Magee Womens Hospital of UPMC
RECRUITING
Pittsburgh
Contact Information
Primary
Maisa Feghali, MD
feghalim@upmc.edu
412 647 1000
Time Frame
Start Date: 2023-04-12
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 13
Treatments
Experimental: Exenatide
Participant receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
Related Therapeutic Areas
Sponsors
Leads: Maisa N. Feghali, MD

This content was sourced from clinicaltrials.gov