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Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Primary Purpose

Gestational Diabetes

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Sponsored by
Maisa N. Feghali, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Magee Womens Hospital of UPMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exenatide

Arm Description

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

Outcomes

Primary Outcome Measures

Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose
Glucose concentration over the course of each study visit following mixed tolerance test

Secondary Outcome Measures

Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide
Drug concentration over the course of the second study visit

Full Information

First Posted
July 18, 2022
Last Updated
April 12, 2023
Sponsor
Maisa N. Feghali, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05482789
Brief Title
Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Official Title
Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maisa N. Feghali, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Experimental
Arm Description
Participant receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
10 microgram injected sub-cutaneously once
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose
Description
Glucose concentration over the course of each study visit following mixed tolerance test
Time Frame
Baseline and 1 week later
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide
Description
Drug concentration over the course of the second study visit
Time Frame
1 week after study enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maisa Feghali, MD
Phone
412 647 1000
Email
feghalim@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maisa Feghali, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maisa Feghali, MD
Phone
412-641-4874
Email
feghalim@upmc.edu
First Name & Middle Initial & Last Name & Degree
Maisa Feghali, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

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