Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: Exenatide
* Genetic: Buccal/blood Sample Collection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing. | Drug: Exenatide<br>* 10 microgram injected sub-cutaneously once<br>* Other names: Byetta;Genetic: Buccal/blood Sample Collection<br>* Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing<br>|
| No Intervention: B<br>Patients given mixed meal test and blood samples drawn for laboratory testing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control through insulin, glucose, c-peptide and glucagon assays |  | duing testing days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCF7L2 polymorphism |  | During subject testing days | 
| Exenatide Pharmacodynamics and Pharmacokinetics |  | During testing days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exenatide, TCF7L2 polymorphism, Pharmacodynamics, Pharmacokinetics