Gestational DiabetesPhase 4NCT00572689
Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
A Phase 4 study testing Exenatide and Buccal/blood Sample Collection in people with Gestational Diabetes, run by Georgetown University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Exenatide and Buccal/blood Sample Collection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women (singleton)
- Gestational diabetes not requiring medical therapy
- Between 18 and 50 years of age
- Able to give written informed consent
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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
- Being tested
- Exenatide, Buccal/blood Sample Collection
- Keywords
- Exenatide, TCF7L2 polymorphism, Pharmacodynamics, Pharmacokinetics
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
10 microgram injected sub-cutaneously once
Buccal/blood Sample CollectionGenetic
Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing. Receives: Drug: Exenatide; Genetic: Buccal/blood Sample Collection |
| B | No intervention | Patients given mixed meal test and blood samples drawn for laboratory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control through insulin, glucose, c-peptide and glucagon assays
Measured: duing testing days
Secondary outcomes (2)
TCF7L2 polymorphism
Measured: During subject testing days
Exenatide Pharmacodynamics and Pharmacokinetics
Measured: During testing days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Principal investigator, Jason Umans, Georgetown University
- Investigators
- Jason G Umans, MD, PhD, Principal investigator, Georgetown University Medical Center, Medstar Health Research InstituteMaisa N Feghali, MD, Study director, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572689
- Sponsor's protocol ID
- Exenatide.GDM
- Other IDs
- 202-801-2636
- Status last verified
- Aug 2015
- First submitted
- 12 Dec 2007
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT00572689
- Acronym / sponsor ID
- Exenatide.GDM
- Conditions
- Gestational Diabetes
- Keywords
- Exenatide, TCF7L2 polymorphism, Pharmacodynamics, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Medstar Health Research Institute
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Exenatide, Genetic: Buccal/blood Sample CollectionSubject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing. |
| B | No intervention | –Patients given mixed meal test and blood samples drawn for laboratory testing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women (singleton)
- Gestational diabetes not requiring medical therapy
- Between 18 and 50 years of age
- Able to give written informed consent
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: Byetta10 microgram injected sub-cutaneously once | Drug | A |
| Buccal/blood Sample CollectionBuccal/blood Sample collection for TCF7L2 polymorphism genetic testing | Genetic | A |
Primary outcome
glycemic control through insulin, glucose, c-peptide and glucagon assays
Time frame: duing testing days
2 secondary outcomes
TCF7L2 polymorphism
Time frame: During subject testing days
Exenatide Pharmacodynamics and Pharmacokinetics
Time frame: During testing days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason G Umans, MD, PhD principal investigator
Georgetown University Medical Center, Medstar Health Research Institute
Maisa N Feghali, MD study director
Medstar Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide and Buccal/blood Sample Collection in people with Gestational Diabetes, run by Georgetown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic control through insulin, glucose, c-peptide and glucagon assays (time frame: duing testing days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.