Insulin Absent | Insulin short-term allowed | Hospitalization Treatment allowed | Treatment Gestational Diabetes allowed
Item
insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0019993 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Metformin | Combined Modality Therapy | Pills Releasing Insulin | Sulfonylurea | Glinides | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Acarbose | Dose unchanged | Dose Minimum U/day | Maximum Tolerated Dose U/day
Item
current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (su) or glinide), dpp-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily) -insulin secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -dpp-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0994475 (UMLS CUI [3,1])
C1283071 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
C0038766 (UMLS CUI [4])
C3537178 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C0050393 (UMLS CUI [8])
C0178602 (UMLS CUI [9,1])
C0442739 (UMLS CUI [9,2])
C0178602 (UMLS CUI [10,1])
C1524031 (UMLS CUI [10,2])
C0456683 (UMLS CUI [10,3])
C0752079 (UMLS CUI [11,1])
C0456683 (UMLS CUI [11,2])
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) below or equal to 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Thiazolidinediones | exenatide | liraglutide
Item
use within the last 3 months prior to visit 1 of: thiazoledinediones, 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 | Contraceptives, Oral, Hormonal | Injectable contraception | Contraceptive implant | Female Sterilization | Intrauterine Devices | Intrauterine System | Contraception, Barrier
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for uk: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
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])
C0009907 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C4293370 (UMLS CUI [10])
C0004764 (UMLS CUI [11])
Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history of cancer hereof (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])