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

Healthy Clinical Trial

Official title:

An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900834
• Other study ID #: INS-4099
• Secondary ID: U1111-1140-1650
• Status: Completed
• Phase: Phase 0
• First received: June 28, 2013
• Last updated: October 7, 2016
• Start date: July 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• No treatment given
The participants will not receive any treatment

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in CD8 (cluster of differentiation) +T-cell specificity profiling		Over a one year period	No
Secondary	Variation in CD4 +T-cell specificity profiling		Over a one year period	No
Secondary	Change in stimulated C-peptide		Baseline, one year	No
Secondary	Fluctuation in islet autoantibodies titers		Over a one year period	No
Secondary	Variation in HbA1c (glycosylated haemoglobin)		Over a one year period	No

External Links

•   Clinical Trials at Novo Nordisk