Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement | Treatment goal Hemoglobin A1c level Median
Item
hba1c 7.0-10.0 % (both inclusive) with the aim of a median hba1c of 8.3%. accordingly, when approximately 50% of the randomised subjects have a hba1c above 8.3%, the remaining subjects randomised must have a hba1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a hba1c of below or equal to 8.3%, the remaining subjects randomised must have a hba1c above 8.3%
boolean
C0474680 (UMLS CUI [1])
C0679840 (UMLS CUI [2,1])
C0474680 (UMLS CUI [2,2])
C0876920 (UMLS CUI [2,3])
Age | Taiwan
Item
male or female, age 18 years or above (taiwan: 20 years or above for a site 653 in taiwan: taichung veterans general hospital)
boolean
C0001779 (UMLS CUI [1])
C0039260 (UMLS CUI [2])
Antidiabetics Oral Dose Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Pioglitazone Dose
Item
subjects on stable dose of 1-2 oads (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0071097 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) maximum 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Insulin regime | Exception Treatment short-term | Etiology Comorbidity
Item
treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
GLP-1 Receptor Agonist | exenatide | liraglutide | Sulfonylurea | Dipeptidyl Peptidase 4 Inhibitors
Item
treatment with glp-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (dpp-4) inhibitors within 90 days prior to trial
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C2917254 (UMLS CUI [5])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferese (alat) at least 2.5 times upper normal range (unr) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender | Medical contraindication Metformin
Item
impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
Calcitonin measurement
Item
screening calcitonin at least 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
subjects with personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction | Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0877341 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C3495793 (UMLS CUI [7,1])
C1301732 (UMLS CUI [7,2])
C1096418 (UMLS CUI [8,1])
C1301732 (UMLS CUI [8,2])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm hg or diastolic blood pressure at least 100 mm hg)
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])
Treatment required for Proliferative retinopathy | Treatment required for Disorder of macula of retina | Treatment required for Macular retinal edema
Item
acute treatment required proliferative retinopathy or maculopathy (macular oedema)
boolean
C0332121 (UMLS CUI [1,1])
C0339467 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C0730362 (UMLS CUI [2,2])
C0332121 (UMLS CUI [3,1])
C0271051 (UMLS CUI [3,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])