Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
Status: | Completed |
---|---|
Conditions: | Healthy Studies, Diabetes, Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology, Other |
Healthy: | No |
Age Range: | 14 - 60 |
Updated: | 4/21/2016 |
Start Date: | July 2013 |
End Date: | October 2015 |
An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
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.
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.
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
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