Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Maisa N. Feghali, MD
Study ID
NCT05482789
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Exenatide — DRUG
    10 microgram injected sub-cutaneously once

Study Details

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.

Key Dates

Start date
Apr 12, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Magee Womens Hospital of UPMCPittsburghPennsylvania15213
Maisa Feghali, MD
[email protected]
412 641 4874
Maisa Feghali, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Magee Womens Hospital of UPMC· Pittsburgh, PA

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