Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Recruiting now · Phase 4
Conditions studied: Gestational Diabetes
In brief
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 facts
- Study ID
- NCT05482789
- Run by
- Maisa N. Feghali, MD
- People needed
- 13
- Starts
- 2023-04-12
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-20
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
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)
Where it is running
- Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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