Current partner codePEPTIDESDE
NCT05482789·Phase 4·INTERVENTIONAL

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Status

Recruiting

Phase

Phase 4

Enrollment

13

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Exenatide

10 microgram injected sub-cutaneously once

Timeline

From registration to results.

  1. First posted

    Aug 1, 2022

  2. Study start

    Apr 12, 2023

  3. Primary completion

    Dec 31, 2025

  4. Study completion

    Dec 31, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 20, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
50 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.