Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMaisa N. Feghali, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women (singleton)

Gestational diabetes not requiring medical therapy

Between 18 and 50 years of age

Able to give written informed consent

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Exenatide

    Drug

    10 microgram injected sub-cutaneously once

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: ExenatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose

Glucose concentration over the course of each study visit following mixed tolerance test

Time frame
Baseline and 1 week later

Secondary outcomes

1

Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide

Drug concentration over the course of the second study visit

Time frame
1 week after study enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maisa N. Feghali, MD

Lead sponsor

University of Pittsburgh

Sponsor institution