Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
GLP-1 Receptor Agonist Dose Maximum | Victoza Dose times/day | Liraglutide Dose times/day | Byetta Dose times/day | Exenatide Dose times/day | Victoza Maximum Tolerated Dose
Item
treatment with daily glp-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (od) victoza® (liraglutide) or 10 microgram twice daily (bid) byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg od victoza®
boolean
C2917359 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C2732208 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439511 (UMLS CUI [2,3])
C1456408 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0439511 (UMLS CUI [3,3])
C1636686 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0439511 (UMLS CUI [4,3])
C0167117 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0439511 (UMLS CUI [5,3])
C2732208 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
Liraglutide Maximum Tolerated Dose | Byetta Maximum Tolerated Dose | Exenatide Maximum Tolerated Dose | Combined Modality Therapy | Metformin Dose U/day | Metformin Maximum Tolerated Dose
Item
(liraglutide) or 5 microgram bid byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (visit 1)
boolean
C1456408 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C1636686 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0167117 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0009429 (UMLS CUI [4])
C0025598 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
C0025598 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
Body mass index
Item
bmi (body mass index) equal to or below 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral | Exception Metformin | Exception Pioglitazone | Exception Sulfonylurea
Item
any use of oral anti-diabetic drugs (oads) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (visit 1)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0071097 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0038766 (UMLS CUI [4,2])
Pharmaceutical Preparations Interfere with Blood glucose level | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Metformin | Exception Pioglitazone | Exception Sulfonylurea | Exception GLP-1 Receptor Agonis
Item
use of any drug (except metformin,pioglitazone, sulphonylurea and glp-1 receptor agonist) which in the investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0392201 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0071097 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C2917359 (UMLS CUI [6,2])
Insulin regime | Treatment short-term allowed | Etiology Comorbidity | Etiology Gestational Diabetes
Item
treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
Calcitonin measurement
Item
screening calcitonin equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Cardiovascular Diseases | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction | Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
cardiovascular disorders defined as: congestive heart failure (new york heart association (nyha) class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
boolean
C0007222 (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])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for | Macular retinal edema Treatment required for
Item
proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the investigator's opinion
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0271051 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Disease Interferes with Research results | Disease Investigational New Drugs At risk | Gastrointestinal Disease | Lung disease | Endocrine System Disease | Exception Non-Insulin-Dependent Diabetes Mellitus | Nervous system disorder | Disorder of the genitourinary system | Hematological Disease
Item
subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the investigator may confound the results of the trial or pose additional risk in administering trial products
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0017178 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0011860 (UMLS CUI [6,2])
C0027765 (UMLS CUI [7])
C0080276 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])