Type I DiabetesPhase 2NCT01928329
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
A Phase 2 study testing Exenatide (Bydureon®) in people with Type I Diabetes, run by Yale University at 8 sites in United States.
Trial summary
The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Exenatide (Bydureon®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2013to Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria.
- Diagnosis of T1DM at least 2 years from Visit 0
- Insulin Requirement of ≤ 0.90 units/kg
- Absence of ketoacidosis in the past 6 months
- HbA1c of ≥ 6.5% and ≤ 9.5%
- 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
- Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status.
- Known hypersensitivity to Exenatide, Liraglutide or any product component.
- Participation in an investigational treatment trial within the last 6 weeks before enrollment.
- 1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months.
- Another condition that would, in the view of the investigator, affect the safety of using Bydureon. This might include, among others a history of MEN 2, a history of medullary carcinoma of the thyroid or pancreatitis.
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- Known severe renal impairment, end-stage renal disease or renal transplantation.
- 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.
- Clinically active serious infection.
- Positive pregnancy test in menstruating women or lactating females.
- Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes medications other than insulin.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48105
Barbara Davis Center
Aurora, Colorado
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut
University of California, San Francisco
San Francisco, California
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)
Read the detailed description
This is a multi-site randomized placebo controlled trial of Bydureon in patients with type I diabetes (T1D) of at least 2 years duration who may or may not still have detectable levels of C-peptide during a mixed meal tolerance test (MMTT). Bydureon is a recently approved long acting form of Exenatide. Because of the lack of safety data for Bydureon in children, we propose to conduct the trial in adults (>18 yrs.).
Both the subject and the study personnel will be blinded to treatment assignment. The randomization will be done, 1;1, by the coordinating site (at Yale). As a secondary analysis, we propose to determine whether the presence of residual insulin production modifies the drug effect. To do this, we plan to stratify patients for randomization on the basis of detectable C-peptide levels. We will therefore wait for the results of the C-peptide levels from the enrollment MMTT prior to randomization. The study investigators will not be told in which stratum the patient is being randomized and will be blinded to the C-peptide results of the MMTT until the conclusion of the study.
Note: The primary and study completion dates were changed 4/2016 to reflect an extension of the recruitment and accrual periods.
- Conditions
- Type I Diabetes
- Being tested
- Exenatide (Bydureon®), Placebo
- 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.
Exenatide (Bydureon®)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 mg, 1 per week via subcutaneous placebo self injection Receives: Drug: Placebo |
| Exenatide (Bydureon) | Experimental | 2 mg, of drug administration 1 per week via subcutaneous self injection Receives: Drug: Exenatide (Bydureon®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c Levels
Measured: 6 months
Secondary outcomes (3)
Change From Baseline in HbA1c Levels
Measured: 12 months
Major Hypoglycemic Event Rate On Drug
The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level < 55 mg/dL.
Measured: Up to 6 months
Major Hypoglycemic Event Rate Off Drug
The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level < 55 mg/dL.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type I 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928329
- Sponsor's protocol ID
- 1307012371
- Status last verified
- Mar 2020
- First submitted
- 19 Aug 2013
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
- ClinicalTrials.gov ID
- NCT01928329
- Acronym / sponsor ID
- 1307012371
- Conditions
- Type I Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)
Detailed description
This is a multi-site randomized placebo controlled trial of Bydureon in patients with type I diabetes (T1D) of at least 2 years duration who may or may not still have detectable levels of C-peptide during a mixed meal tolerance test (MMTT). Bydureon is a recently approved long acting form of Exenatide. Because of the lack of safety data for Bydureon in children, we propose to conduct the trial in adults (>18 yrs.).
Both the subject and the study personnel will be blinded to treatment assignment. The randomization will be done, 1;1, by the coordinating site (at Yale). As a secondary analysis, we propose to determine whether the presence of residual insulin production modifies the drug effect. To do this, we plan to stratify patients for randomization on the basis of detectable C-peptide levels. We will therefore wait for the results of the C-peptide levels from the enrollment MMTT prior to randomization. The study investigators will not be told in which stratum the patient is being randomized and will be blinded to the C-peptide results of the MMTT until the conclusion of the study.
Note: The primary and study completion dates were changed 4/2016 to reflect an extension of the recruitment and accrual periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 mg, 1 per week via subcutaneous placebo self injection |
| Exenatide (Bydureon) | Experimental | Drug: Exenatide (Bydureon®)2 mg, of drug administration 1 per week via subcutaneous self injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria.
- Diagnosis of T1DM at least 2 years from Visit 0
- Insulin Requirement of ≤ 0.90 units/kg
- Absence of ketoacidosis in the past 6 months
- HbA1c of ≥ 6.5% and ≤ 9.5%
Key exclusion criteria (12 listed)
- Inability or unwillingness to give informed consent
- Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status.
- Known hypersensitivity to Exenatide, Liraglutide or any product component.
- Participation in an investigational treatment trial within the last 6 weeks before enrollment.
- 1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months.
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 (Bydureon®) | Drug | Exenatide (Bydureon) |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in HbA1c Levels
Time frame: 6 months
3 secondary outcomes
Change From Baseline in HbA1c Levels
Time frame: 12 months
Major Hypoglycemic Event Rate On Drug
Time frame: Up to 6 months
Major Hypoglycemic Event Rate Off Drug
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exenatide (Bydureon®) in people with Type I Diabetes, run by Yale University at 8 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 7 inclusion and 12 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in HbA1c Levels (time frame: 6 months). 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 19 Mar 2020.