Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

NCT05482789 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY22070080
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline and 1 week later

Secondary Outcomes (1)

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

  1 week after study enrollment

Study Arms (1)

Exenatide

EXPERIMENTAL

Participant receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.

Drug: Exenatide

Interventions

Exenatide DRUG

10 microgram injected sub-cutaneously once

Exenatide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women (singleton)
• Gestational diabetes not requiring medical therapy
• Between 18 and 50 years of age
• Able to give written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maisa N. Feghali, MD: lead

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Exenatide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Maisa Feghali, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maisa Feghali, MD

CONTACT

412 647 1000; feghalim@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: August 1, 2022
• Study Start: April 12, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)