Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
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.
Conditions:
🦠 Gestational Diabetes
🗓️ Study Start (Actual) 12 April 2023
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 13
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 July 2022
  • First Submitted that Met QC Criteria 28 July 2022
  • First Posted 1 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 March 2024
  • Last Update Posted 8 March 2024
  • Last Verified March 2024