Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

NCTNCT05482789Other idSTUDY22070080

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 13 participants (estimated)
Sponsor: Maisa N. Feghali, MD · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 12 Apr 2023
Primary completion: 31 Dec 2025
Completion: 31 Dec 2026 (estimated)
First posted: 1 Aug 2022
Last update posted: 20 Apr 2026
Conditions: Gestational Diabetes

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024202520262027

Ph 4
Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
NCT05482789
12 Apr 2023 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

ExenatideDrug

Arms1

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 outcomes1

Outcomes the sponsor listed as primary.

Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose
Time frame · Baseline and 1 week later
Registry description
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
Registry description
Drug concentration over the course of the second study visit

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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