Diabetes Mellitus, Type 1NCT02067923
AbATE Follow-Up Study
An observational study of Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
Trial summary
This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Read more about this study
- Who is it for?
- Ages 10 to 37 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 17 Nov 2016
- Phase
- Observational
- 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 10 to 37 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The investigators will contact their patients who were originally on the ITN027AI (AbATE) study. Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study.
Who may be able to join
- Prior participation on either the treatment or the control arm of the Abate ITN027AI trial
- Signed Informed Consent
Who cannot join
- Inability or unwillingness to give informed consent
- Participation in an investigational treatment trial within the last 6 weeks before enrollment
- Ongoing major systemic illness.
- Clinically active serious infections.
- Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial.
- Positive pregnancy test in menstruating women
- Actively breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Church Street Research Unit
New Haven, Connecticut, 06519
About this study
Official title: ITN0127AI Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE) Follow-Up Study
This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal antibody is a humanized antibody that is commonly used to prevent organ rejection. It was give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.
The overall hypothesis of this study is there will be less change in c-peptide levels of the previously treated group versus the control group.
Read the detailed description
We propose to conduct a non-interventional multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. The first few subjects went on the trial late in 2005 and the last subjects were enrolled in 2009.The mixed meal tolerance tests will coincide with approximately 4 years and 6 years post ITN027AI study completion for each participant. Those participants, who completed the ITN027AI study in 2007 and 2008, will only have a single MMTT.
We plan to enroll approximately 77 subjects at 5 sites who were previously active with ITN027AI.. Both the drug treated and the control group participants will be invited to participate. Along with Yale University these sites include, the University of California-San Francisco, University of Colorado-Barbara Davis, Benaroya Research Institute, and Pacific Northwest Research Institute -University of Washington. The investigators of each of these sites will be asked to contact their patients who were originally on the ITN027AI study.
Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study. Eligible participants will come to the Yale University Church St. Research Unit or other participating ITN study site for either 1 or 2 mixed meal tolerance tests to determine their current c-peptide status. The available sites for participants to go to include: Yale University, University of California-San Francisco, University of Colorado-Barbara Davis Center, Benaroya Research Institute and Pacific Northwest-University of Washington.
This first visit will consist of the following: an explanation of the study, an assessment of inclusion/exclusion criteria and documentation of informed consent. If the subject meets the inclusion/exclusion criteria, a complete medical history will be obtained, physical examination including vital signs, urine pregnancy test if a female of childbearing potential and an assessment of concomitant medications. The subject will then have a Mixed Meal Tolerance Tests (MMTT) with a possible 2nd MMTT with C-Peptide and glucose measurements a year later based on how long it has been since they were on the ITN027AI Study.The subject will also have a 4 hour urine collection for C-peptide and creatinine during this MMTT. If a repeat MMTT is done a year later then another 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement.
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- T1D, type 1 diabetes, type 1 diabetes mellitus, juvenile diabetes, autoimmune diabetes, autoimmune, anti-CD3 mAb, mAb hOKT3g1(Ala-Ala), teplizumab
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD3 mAb Plus Diabetes Standard of Care Group | This group of individuals received treatment in the original AbATE study. | |
| Diabetes Standard of Care Group | During the original AbATE study these individuals received standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mixed Meal Tolerance Test (MMTT) C-peptide levels
Labs will be obtained to assess beta cell function via c-peptide levels and glucose at 11 time points during the mixed meal tolerance test. Blood samples will be obtained prior to the start of the mixed meal tolerance test to assess auto-antibody status and HbA1c. Approximately 60 cc's of blood will also be obtained for PBMC's and future studies as related to the immunology and genetics of T1DM. A 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement. We plan to determine the relationship between this measurement and the insulin secretory response.
Measured: 1 Study Day
Secondary outcomes (1)
Safety experience
To determine the safety experience and diabetes specific clinical parameters in previous participants in the ITN027 trial via the history of hospitalizations and other adverse events since the participants came of the original ITN027AI Treatment Trial.
Measured: 1 Study Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completion17 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevan Herold, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067923
- Sponsor's protocol ID
- 1310012954
- Status last verified
- Jan 2018
- First submitted
- 18 Feb 2014
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Perdigoto AL, Preston-Hurlburt P, Clark P, Long SA, Linsley PS, Harris KM, Gitelman SE, Greenbaum CJ, Gottlieb PA, Hagopian W, Woodwyk A, Dziura J, Herold KC; Immune Tolerance Network. Treatment of type 1 diabetes with teplizumab: clinical and immunological follow-up after 7 years from diagnosis. Diabetologia. 2019 Apr;62(4):655-664. doi: 10.1007/s00125-018-4786-9. Epub 2018 Dec 19.
PubMed 30569273
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ITN0127AI Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE) Follow-Up Study
- ClinicalTrials.gov ID
- NCT02067923
- Acronym / sponsor ID
- 1310012954
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- T1D, type 1 diabetes, type 1 diabetes mellitus, juvenile diabetes, autoimmune diabetes, autoimmune, anti-CD3 mAb, mAb hOKT3g1(Ala-Ala)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 17 Nov 2016 (actual)
- First posted
- 20 Feb 2014 (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 proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal antibody is a humanized antibody that is commonly used to prevent organ rejection. It was give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.
The overall hypothesis of this study is there will be less change in c-peptide levels of the previously treated group versus the control group.
Detailed description
We propose to conduct a non-interventional multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. The first few subjects went on the trial late in 2005 and the last subjects were enrolled in 2009.The mixed meal tolerance tests will coincide with approximately 4 years and 6 years post ITN027AI study completion for each participant. Those participants, who completed the ITN027AI study in 2007 and 2008, will only have a single MMTT.
We plan to enroll approximately 77 subjects at 5 sites who were previously active with ITN027AI.. Both the drug treated and the control group participants will be invited to participate. Along with Yale University these sites include, the University of California-San Francisco, University of Colorado-Barbara Davis, Benaroya Research Institute, and Pacific Northwest Research Institute -University of Washington. The investigators of each of these sites will be asked to contact their patients who were originally on the ITN027AI study.
Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study. Eligible participants will come to the Yale University Church St. Research Unit or other participating ITN study site for either 1 or 2 mixed meal tolerance tests to determine their current c-peptide status. The available sites for participants to go to include: Yale University, University of California-San Francisco, University of Colorado-Barbara Davis Center, Benaroya Research Institute and Pacific Northwest-University of Washington.
This first visit will consist of the following: an explanation of the study, an assessment of inclusion/exclusion criteria and documentation of informed consent. If the subject meets the inclusion/exclusion criteria, a complete medical history will be obtained, physical examination including vital signs, urine pregnancy test if a female of childbearing potential and an assessment of concomitant medications. The subject will then have a Mixed Meal Tolerance Tests (MMTT) with a possible 2nd MMTT with C-Peptide and glucose measurements a year later based on how long it has been since they were on the ITN027AI Study.The subject will also have a 4 hour urine collection for C-peptide and creatinine during this MMTT. If a repeat MMTT is done a year later then another 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-CD3 mAb Plus Diabetes Standard of Care Group | – | –This group of individuals received treatment in the original AbATE study. |
| Diabetes Standard of Care Group | – | –During the original AbATE study these individuals received standard care. |
Who may qualify
- Ages
- 10 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The investigators will contact their patients who were originally on the ITN027AI (AbATE) study. Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study.
Key inclusion criteria (2 listed)
- Prior participation on either the treatment or the control arm of the Abate ITN027AI trial
- Signed Informed Consent
Key exclusion criteria (7 listed)
- Inability or unwillingness to give informed consent
- Participation in an investigational treatment trial within the last 6 weeks before enrollment
- Ongoing major systemic illness.
- Clinically active serious infections.
- Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mixed Meal Tolerance Test (MMTT) C-peptide levels
Time frame: 1 Study Day
Labs will be obtained to assess beta cell function via c-peptide levels and glucose at 11 time points during the mixed meal tolerance test. Blood samples will be obtained prior to the start of the mixed meal tolerance test to assess auto-antibody status and HbA1c. Approximately 60 cc's of blood will also be obtained for PBMC's and future studies as related to the immunology and genetics of T1DM. A 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement. We plan to determine the relationship between this measurement and the insulin secretory response.
1 secondary outcome
Safety experience
Time frame: 1 Study Day
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 17 Jan 2018.
- Derived from this study: PubMed 30569273Perdigoto AL, Preston-Hurlburt P, Clark P, Long SA, Linsley PS, Harris KM, Gitelman SE, Greenbaum CJ, Gottlieb PA, Hagopian W, Woodwyk A, Dziura J, Herold KC; Immune Tolerance Network. Treatment of type 1 diabetes with teplizumab: clinical and immunological follow-up after 7 years from diagnosis. Diabetologia. 2019 Apr;62(4):655-664. doi: 10.1007/s00125-018-4786-9. Epub 2018 Dec 19.
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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 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?
An observational study of Diabetes Mellitus, Type 1, 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 2 inclusion and 7 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 17 Jan 2018. 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.
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?
Mixed Meal Tolerance Test (MMTT) C-peptide levels (time frame: 1 Study Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067923, which also lists 1 linked publication.
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 17 Jan 2018.