Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Key facts
- Who runs it
- Maisa N. Feghali, MD
- Where
- Pittsburgh, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 13 people, planned
- Started
- 12 Apr 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Exenatide
- Record updated
- 20 April 2026
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Pregnant women (singleton)
- Gestational diabetes not requiring medical therapy
- Between 18 and 50 years of age
- Able to give written informed consent
Who cannot take part
- 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)
- Women in the first trimester of pregnancy
- Hematocrit less than 30%
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- Magee-Womens Hospital of UPMCPittsburgh, United StatesContact: Maisa Feghali, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- ExenatideTreatment being tested
Participant receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
- Fit questions
- Built from NCT05482789, who can take part
- Record updated
- 20 April 2026