Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
- - type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to visit 2 (randomisation)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Glargine | Antidiabetics Oral Quantity | Metformin | Dipeptidyl Peptidase 4 Inhibitors | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | Diabetes Therapy Dose Stable
Item
- - currently treated with iglar (insulin glargine) and up to 3 oral antidiabetic drugs (oads) (metformin, dpp-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). all antidiabetic treatments should have been ongoing for at least 12 weeks prior to visit 2 (randomisation) and doses should have been stable in this period of time
boolean
C0907402 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3])
C2917254 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C3274787 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
Hemoglobin A1c measurement
Item
- - glycosylated haemoglobin (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 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
GLP-1 Receptor Agonist | Thiazolidinediones
Item
- - treatment with glucagon-like peptide 1 (glp-1) receptor agonists or thiazolidinediones (tzds) both within the last 12 weeks prior to visit 2 (randomisation)
boolean
C2917359 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Cerebrovascular accident | Heart failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
- - stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to visit 2 (randomisation)
boolean
C0038454 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0162577 (UMLS CUI [6])
Uncontrolled hypertension Severe | Severe hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
- - uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4013784 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning
Item
- - recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
Life threatening illness | Malignant Neoplasms
Item
- - life-threatening disease (e.g. cancer)
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])