Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Lifestyle change therapy | Metformin
Item
diet and lifestyle changes or metformin monotherapy for at least three months
boolean
C0012159 (UMLS CUI [1])
C2960841 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) less than or equal to 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Insulin regime | Exception Insulin regime short-term Comorbidity
Item
previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
GLP-1 Mimetics | Study Subject Participation Status
Item
previous treatment with glucagon-like peptide-1 (glp-1) analogues/mimetics, including treatment in a clinical trial
boolean
C3273809 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Oral hypoglycemic | Exception Metformin
Item
treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening
boolean
C0359086 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Tobacco use
Item
current smoker or history of smoking within 6 months prior to screening
boolean
C0543414 (UMLS CUI [1])
Cardiovascular Diseases | Coronary heart disease | Congestive heart failure New York Heart Association Classification | Cerebrovascular Disorders | Peripheral Vascular Diseases
Item
evidence of overt cardiovascular disease (documented coronary heart disease, class ii-iv congestive heart failure, cerebrovascular disease, or peripheral vascular disease)
boolean
C0007222 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0007820 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
Exercise stress ECG test Abnormal
Item
abnormal, clinically significant exercise stress electrocardiogram (ecg) test, as judged by the investigator
boolean
C1304755 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Retinal Disease Treatment required for | Disorder of macula of retina Treatment required for
Item
known retinopathy or maculopathy requiring acute treatment, as judged by the investigator
boolean
C0035309 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Autonomic neuropathy
Item
known autonomic neuropathy, as judged by the investigator
boolean
C0259749 (UMLS CUI [1])
Antihypertensive Agents Initiation | Antihypertensive Agents Dose Change | Antihypertensive Agents Change | Hypoglycemic Agents Initiation | Hypoglycemic Agents Dose Change | Hypoglycemic Agents Change
Item
initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening
boolean
C0003364 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0020616 (UMLS CUI [4,1])
C1704686 (UMLS CUI [4,2])
C0020616 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0392747 (UMLS CUI [5,3])
C0020616 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure more than or equal to 140 mmhg and/or diastolic blood pressure more than or equal to 90 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])