DiabetesNCT01900834
Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
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 this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 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 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects with T1D, T2D and healthy subjects (HS) without personal or first degree family history of autoimmunity of diabetes. The HS will be mean age-matched with the T1D subjects.
Who may be able to join
- T1D
- Male or female subjects diagnosed within the last 3 years and with good general health based on medical history
- Age above or equal to 14 years and below or equal to 40 years
- Body weight above 45 kg
- T2D
- Male or female subjects diagnosed within the last 15 years with good general health based on medical history
Show all 13Show fewer
- HbA1c between 6.5% and 10%
- Body mass index (BMI) below 45 kg/m^2
- Age above or equal to 18 and below 65 years
- On insulin treatment
- HS
- Male or female subjects with good general heath based on medical history
- Age above or equal to 18 years and below or equal to 40 years
Who cannot join
- Any chronic disorder (besides T1D or T2D) 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 Investigational Site
Princeton, New Jersey, 08540
About this study
Official title: An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
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.
Variation in CD8 (cluster of differentiation) +T-cell specificity profiling
Measured: Over a one year period
Secondary outcomes (4)
Variation in CD4 +T-cell specificity profiling
Measured: Over a one year period
Change in stimulated C-peptide
Measured: Baseline, one year
Fluctuation in islet autoantibodies titers
Measured: Over a one year period
Variation in HbA1c (glycosylated haemoglobin)
Measured: Over a one year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2015
- Study completionOct 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
- 61 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
- NCT01900834
- Sponsor's protocol ID
- INS-4099
- Other IDs
- U1111-1140-1650
- Status last verified
- Oct 2016
- First submitted
- 28 Jun 2013
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
- ClinicalTrials.gov ID
- NCT01900834
- Acronym / sponsor ID
- INS-4099
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Jul 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 this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.
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
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects with T1D, T2D and healthy subjects (HS) without personal or first degree family history of autoimmunity of diabetes. The HS will be mean age-matched with the T1D subjects.
Key inclusion criteria (13 listed)
- T1D
- Male or female subjects diagnosed within the last 3 years and with good general health based on medical history
- Age above or equal to 14 years and below or equal to 40 years
- Body weight above 45 kg
- T2D
Key exclusion criteria (2 listed)
- Any chronic disorder (besides T1D or T2D) 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
Variation in CD8 (cluster of differentiation) +T-cell specificity profiling
Time frame: Over a one year period
4 secondary outcomes
Variation in CD4 +T-cell specificity profiling
Time frame: Over a one year period
Change in stimulated C-peptide
Time frame: Baseline, one year
Fluctuation in islet autoantibodies titers
Time frame: Over a one year period
Variation in HbA1c (glycosylated haemoglobin)
Time frame: Over a one year period
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 10 Oct 2016.
- 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 13 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 10 Oct 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.
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?
Variation in CD8 (cluster of differentiation) +T-cell specificity profiling (time frame: Over a one year period). 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 10 Oct 2016.