Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482789
• Other study ID #: STUDY22070080
• Status: Recruiting
• Phase: Phase 4
• Start date: April 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Maisa Feghali, MD
• Phone: 412 647 1000
• Email: feghalim[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• Exenatide
10 microgram injected sub-cutaneously once

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Maisa N. Feghali, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose	Glucose concentration over the course of each study visit following mixed tolerance test	Baseline and 1 week later
Secondary	Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide	Drug concentration over the course of the second study visit	1 week after study enrollment