Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

• Status: Withdrawn
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

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, we 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 your 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, we hope to find out if exenatide might also be helpful in gestational diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborators: Medstar Health Research Institute; Washington Hospital Center
• Treatments: Exenatide

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)