Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05482789

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Maisa Feghali, MD

CONTACT

[email protected]

412 641 4874

Maisa Feghali, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

exenatide

Drug

10 microgram injected sub-cutaneously once

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose

    Time frame: Baseline and 1 week later

    Glucose concentration over the course of each study visit following mixed tolerance test

Secondary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide

    Time frame: 1 week after study enrollment

    Drug concentration over the course of the second study visit

Study contacts

Contact information is provided by the study sponsor or research team.

Maisa Feghali, MD

CONTACT

[email protected]

412 647 1000

Sponsors and collaborators

Lead sponsor

Maisa N. Feghali, MD

Other

Registry information

Official study title

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.