Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

NCT ID: NCT05482789

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2026-03-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

10 microgram injected sub-cutaneously once

Interventions

Exenatide

10 microgram injected sub-cutaneously once

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maisa N. Feghali, MD

OTHER

Sponsor Role: lead

Responsible Party

Maisa N. Feghali, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maisa Feghali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maisa Feghali, MD

Role: CONTACT

feghalim@upmc.edu

412 647 1000

Facility Contacts

Maisa Feghali, MD

Role: primary

feghalim@upmc.edu

412-641-4874

Other Identifiers

STUDY22070080

Identifier Type: -

Identifier Source: org_study_id