About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women (singleton)
Gestational diabetes not requiring medical therapy
Between 18 and 50 years of age
Able to give written informed consent
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Exenatide
Drug10 microgram injected sub-cutaneously once
Treatment groups
Trial outcomes
Primary outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose
Glucose concentration over the course of each study visit following mixed tolerance test
Secondary outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide
Drug concentration over the course of the second study visit
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maisa N. Feghali, MD
Lead sponsor
University of Pittsburgh
Sponsor institution