DiabetesNCT01846312
An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 4 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- No treatment given
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2015
- 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 4 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects who are at risk for developing T1D either by genetic testing or due to family history and identified with one or more islet autoantibodies).
Who may be able to join
- Subjects with general good health as judged by the investigator
- Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody))
Who cannot join
- Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
- Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, 08540
About this study
Official title: The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
The participants will not receive any treatment.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluctuation in islet autoantibodies titers
Measured: One-two years dependent on sampling frequency
Secondary outcomes (2)
Fluctuation in islet autoantibody isotypes
Measured: One-two years dependent on sampling frequency
Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells)
Measured: One-two years dependent on sampling frequency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846312
- Sponsor's protocol ID
- INS-4074
- Other IDs
- U1111-1136-8383
- Status last verified
- Sep 2015
- First submitted
- 30 Apr 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01846312
- Acronym / sponsor ID
- INS-4074
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 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.
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: No treatment given |
Who may qualify
- Ages
- 4 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects who are at risk for developing T1D either by genetic testing or due to family history and identified with one or more islet autoantibodies).
Key inclusion criteria (2 listed)
- Subjects with general good health as judged by the investigator
- Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody))
Key exclusion criteria (2 listed)
- Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
- Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
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 |
|---|---|---|
| No treatment givenThe participants will not receive any treatment. | Other | All participants |
Primary outcome
Fluctuation in islet autoantibodies titers
Time frame: One-two years dependent on sampling frequency
2 secondary outcomes
Fluctuation in islet autoantibody isotypes
Time frame: One-two years dependent on sampling frequency
Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells)
Time frame: One-two years dependent on sampling frequency
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 23 Sep 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S 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 2 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 23 Sep 2015. 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?
Fluctuation in islet autoantibodies titers (time frame: One-two years dependent on sampling frequency). 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 23 Sep 2015.