An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT01846312

INS-4074

U1111-1136-8383 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 4 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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 design

40 participants in 1 patient group

All participants

Treatment:

Other: No treatment given