Type 1 DiabetesPhase 1NCT01855490
Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
A Phase 1 study testing Exenatide in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
Trial summary
The study is designed as an open labeled pilot trial to analyze the acute responses of glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide (Byetta) 5 mcg sc. Read more about this study
- Who is it for?
- Ages 18 to 56 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2013
- Phase
- Phase 1
- 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 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- T1D of at least 3 yrs duration.
- Male or female aged 18-56 years who meets the American Diabetes Association standard T1DM criteria.
- HgbA1c<9%
- Insulin requirement of < 0.8 U/kg/d
- Absence of severe hypoglycemia in the past 6 months
- Absence of ketoacidosis in the past 6 months
- Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period.
- Signed informed consent..
Who cannot join
- Inability or unwillingness to give informed consent.
- Prior Exenatide or Liraglutide treatment or use of any medication that could potentially affect diabetes or immunologic status
- Known hypersensitivity to Exenatide or any product components
- Participation in an investigational treatment trial within the last 6 weeks before enrollment.
- Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial such as: epilepsy, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease,liver disease, HIV, or any concurrent autoimmune disease except treated and stable thyroid disease
- Known severe renal impairment, end-stage renal disease or renal transplantation.
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- Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma.
- Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment.
- Active clinically serious infections.
- Positive pregnancy test in menstruating women or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06519
About this study
Official title: A Pilot Study to Determine the Effects of a Single Dose of Exenatide (Byetta ®) on the Acute Metabolic Responses to a Mixed Meal or Intravenous Glucose Tolerance Test in Patients With Type 1 Diabetes
The study is designed as an open labeled pilot trial to analyze the acute responses of glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide (Byetta) 5 mcg sc.
The investigators will also test the effects of Exenatide on gastric emptying during the MMTT.
- Conditions
- Type 1 Diabetes
- Being tested
- Exenatide
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
| Study group | Role | What they receive |
|---|---|---|
| Single-arm treatment with Exenatide | Experimental | Exenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production.
We will measure the hormonal and metabolic changes during a mixed meal and intravenous glucose tolerance test with and without exenatide pretreatment in subjects with and without residual insulin production.
Measured: Each patients is estimated to finish the study within 4-6 weeks
Secondary outcomes (1)
Effect of exenatide on insulin secretion, glucagon secretion, GLP-1 and GIP levels, and gastric emptying in these patients with T1D. - effect of exenatide on residual insulin production
In addition to measuring the levels of glucose and gastric emptying, we will measured glucagon levels, insulin secretion rates, GLP-1 and GIP hormonal levels during the provocative tests.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevan C Herold, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855490
- Sponsor's protocol ID
- 1201009520
- Status last verified
- Jul 2016
- First submitted
- 29 Jan 2013
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effects of a Single Dose of Exenatide (Byetta ®) on the Acute Metabolic Responses to a Mixed Meal or Intravenous Glucose Tolerance Test in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01855490
- Acronym / sponsor ID
- 1201009520
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 May 2013 (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.
The study is designed as an open labeled pilot trial to analyze the acute responses of glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide (Byetta) 5 mcg sc.
The investigators will also test the effects of Exenatide on gastric emptying during the MMTT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm treatment with Exenatide | Experimental | Drug: ExenatideExenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- T1D of at least 3 yrs duration.
- Male or female aged 18-56 years who meets the American Diabetes Association standard T1DM criteria.
- HgbA1c<9%
- Insulin requirement of < 0.8 U/kg/d
- Absence of severe hypoglycemia in the past 6 months
Key exclusion criteria (10 listed)
- Inability or unwillingness to give informed consent.
- Prior Exenatide or Liraglutide treatment or use of any medication that could potentially affect diabetes or immunologic status
- Known hypersensitivity to Exenatide or any product components
- Participation in an investigational treatment trial within the last 6 weeks before enrollment.
- Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial such as: epilepsy, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease,liver disease, HIV, or any concurrent autoimmune disease except treated and stable thyroid 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 |
|---|---|---|
| Exenatide | Drug | Single-arm treatment with Exenatide |
Primary outcome
Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production.
Time frame: Each patients is estimated to finish the study within 4-6 weeks
We will measure the hormonal and metabolic changes during a mixed meal and intravenous glucose tolerance test with and without exenatide pretreatment in subjects with and without residual insulin production.
1 secondary outcome
Effect of exenatide on insulin secretion, glucagon secretion, GLP-1 and GIP levels, and gastric emptying in these patients with T1D. - effect of exenatide on residual insulin production
Time frame: 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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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.
Kevan C Herold, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exenatide in people with Type 1 Diabetes, run by Yale University at 1 site 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production. (time frame: Each patients is estimated to finish the study within 4-6 weeks). 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 7 Jul 2016.