Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Sulfonylurea Dose Stable Daily | Metformin Dose | Metformin Maximum Tolerated Dose | Metformin Absent
Item
subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (visit 1)
boolean
C0038766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) below or equal to 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral | Exception Sulfonylurea | Exception Combined Modality Therapy Metformin
Item
any use of oral anti-diabetic drugs (oads) (other than su in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (visit 1)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0009429 (UMLS CUI [3,2])
C0025598 (UMLS CUI [3,3])
Pharmaceutical Preparations Interfere with Blood glucose level | Exception Sulfonylurea | Exception Combined Modality Therapy Metformin | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
use of any drug (other than su in monotherapy or in combination with metformin), which in the investigators 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])
C1705847 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0009429 (UMLS CUI [3,2])
C0025598 (UMLS CUI [3,3])
C3653708 (UMLS CUI [4])
GLP-1 Receptor Agonist | exenatide | liraglutide
Item
previous treatment with glucagon-like peptide-1 (glp-1) receptor agonist (e.g. exenatide, liraglutide)
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
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 above or equal to 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 | Macular retinal edema
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])
C0271051 (UMLS CUI [3])
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 clinical 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 product
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])