Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-08-31

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.

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Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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A

Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

10 microgram injected sub-cutaneously once

Buccal/blood Sample Collection

Intervention Type GENETIC

Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

B

Patients given mixed meal test and blood samples drawn for laboratory testing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exenatide

10 microgram injected sub-cutaneously once

Intervention Type DRUG

Buccal/blood Sample Collection

Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing

Intervention Type GENETIC

Other Intervention Names

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Byetta

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No