Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Sitagliptin Dose U/day
Item
subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. stable is defined as unchanged medication and dose
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C1565750 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
Hemoglobin A1c measurement
Item
hba1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index equal to or above 20 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease Protocol Compliance At risk | Disease Severe Protocol Compliance At risk
Item
any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C1444641 (UMLS CUI [4,4])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity
Item
treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. an exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value 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 or multiple endocrine neoplasia syndrome type 2
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])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate 60 ml/min/1.73 m^2 per modification of diet in renal disease formula
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event
Item
any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
boolean
C0332189 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C1320716 (UMLS CUI [5])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])