Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exenatide.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Overview
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
- Drug Exenatide
10 microgram injected sub-cutaneously once
Primary outcome measures
- Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose [Time frame: Baseline and 1 week later]
Secondary outcome measures (1)
- Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide [Time frame: 1 week after study enrollment]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Magee Womens Hospital of UPMC — Pittsburgh
Identifiers
NCT: NCT05482789 · STUDY22070080