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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT01900834

INS-4099

U1111-1140-1650 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 14 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

61 participants in 1 patient group

All participants

Treatment:

Other: No treatment given