Age | Japan
Item
male or female at least 18 years of age (at least 20 years for japan)
boolean
C0001779 (UMLS CUI [1])
C0022341 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin times per day | Insulin Analogue times per day | Metformin | Metformin Absent | Premixed insulin | Premixed insulin Analogue | Insulin regime Self Mixed | Short-Acting Insulin Percentage
Item
subject on basal human or analogue insulin, once daily (od) or twice daily (bid) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, od or bid, with or without metformin, for at least 3 months
boolean
C0650607 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C2825028 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2069057 (UMLS CUI [5])
C2069057 (UMLS CUI [6,1])
C0243071 (UMLS CUI [6,2])
C0557978 (UMLS CUI [7,1])
C0036588 (UMLS CUI [7,2])
C0205430 (UMLS CUI [7,3])
C0356365 (UMLS CUI [8,1])
C0439165 (UMLS CUI [8,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) maximum 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral | Exception Metformin
Item
treatment with oral antidiabetic drugs (oads) (except metformin) within the last 8 weeks prior to visit 1
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Thiazolidinediones | GLP-1 Receptor Agonist
Item
treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 3 months prior to visit 1
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0581377 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0162577 (UMLS CUI [7])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])