DRUG
Exenatide
10 microgram injected sub-cutaneously once
Status
Recruiting
Phase
Phase 4
Enrollment
13
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
10 microgram injected sub-cutaneously once
Timeline
First posted
Aug 1, 2022
Study start
Apr 12, 2023
Primary completion
Dec 31, 2025
Study completion
Dec 31, 2026
Results posted
Not reported
Registry updated
Apr 20, 2026
Outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose
Time frame · Baseline and 1 week later
Glucose concentration over the course of each study visit following mixed tolerance test
Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide
Time frame · 1 week after study enrollment
Drug concentration over the course of the second study visit
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)
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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