Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period

NCT ID: NCT01900834

Last Updated: 2016-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

No treatment given

Intervention Type OTHER

The participants will not receive any treatment

Interventions

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No treatment given

The participants will not receive any treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR,1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1140-1650

Identifier Type: OTHER

Identifier Source: secondary_id

INS-4099

Identifier Type: -

Identifier Source: org_study_id

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