Japan | Age
Item
for japan only: minimum age is 20 years
boolean
C0022341 (UMLS CUI [1])
C0001779 (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])
Pills Releasing Insulin | Sulfonylurea | Glinides | Metformin | Combined Modality Therapy | alpha-Glucosidase Inhibitors | alpha-Glucosidase Inhibitors Absent | Dipeptidyl Peptidase 4 Inhibitors | Dipeptidyl Peptidase 4 Inhibitors Absent | Dose unchanged
Item
current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a dpp-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. the dose(s) should as minimum be as stated: -insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -metformin: alone or in combination (including fixed combination): maximum tolerated dose - alfa-glucosidase-inhibitors: minimum half of the daily maximal dose or maximum tolerated dose -dpp-4 (dipeptyl peptidase 4) inhibitor: according to local labelling
boolean
C0994475 (UMLS CUI [1,1])
C1283071 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2])
C3537178 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1299007 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C2917254 (UMLS CUI [8])
C2917254 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0178602 (UMLS CUI [10,1])
C0442739 (UMLS CUI [10,2])
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) no higher than 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Thiazolidinediones | exenatide | liraglutide
Item
use within the last 3 months prior to visit 1 of: tzds (thiazolidinediones), exenatide or liraglutide
boolean
C1257987 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
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 | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermatocidal Agents | Contraceptive patch | Hormone implant | Norplant | Contraceptives, Oral | Postmenopausal state | Female Sterilization
Item
pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
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])
C0042241 (UMLS CUI [5])
C0009653 (UMLS CUI [6,1])
C0682323 (UMLS CUI [6,2])
C0021900 (UMLS CUI [7])
C0183461 (UMLS CUI [8])
C0493327 (UMLS CUI [9])
C0037862 (UMLS CUI [10])
C2985284 (UMLS CUI [11])
C0848131 (UMLS CUI [12])
C1145675 (UMLS CUI [13])
C0009905 (UMLS CUI [14])
C0232970 (UMLS CUI [15])
C0015787 (UMLS CUI [16])
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])