NCT00572689

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	Exenatide	10 microgram injected sub-cutaneously once
GENETIC	Buccal/blood Sample Collection	Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2007-12-13
• Last updated: 2015-08-21

Locations

2 sites across 1 country: United States