Recruiting

Exenatide

Sponsor:

Maisa N. Feghali, MD

Code:

NCT05482789

Conditions

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Exenatide

Study Details

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, 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.

Conditions

Gestational Diabetes

Study ID

NCT05482789

Start date

Apr 12, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

13 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Exenatide

10 microgram injected sub-cutaneously once

Primary outcome measure

  • Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose [ Time Frame: Baseline and 1 week later ]

Central Contacts and Locations

Central contacts

Maisa Feghali, MD

412 647 1000feghalim@upmc.edu

Locations

Magee Womens Hospital of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Maisa Feghali, MD

412 641 4874feghalim@upmc.edu

Principal Investigator:

Maisa Feghali, MD

More Information

Sponsor

Maisa N. Feghali, MD

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisa N. Feghali, MD on 2026-04-20.