What this trial means for you
This study is recruiting now at 1 US site. It's studying Exenatide for gestational diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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 sites by state
Pennsylvania
- Magee Womens Hospital of UPMC — Pittsburgh · Recruiting now
View the official record on ClinicalTrials.gov →
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