Status:
COMPLETED
An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
4-40 years
Brief 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...
Eligibility Criteria
Inclusion
- 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))
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01846312
Start Date
May 1 2013
End Date
September 1 2015
Last Update
September 23 2015
Active Locations (1)
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1
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540