Age | Informed Consent
Item
male or female, age at least 18 years and below 80 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable U/day | Metformin Maximum Tolerated Dose
Item
subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to 1000 mg daily for at least 60 days prior to screening
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index below or equal to 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
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 60 days prior to screening. an exception is short-term treatment (below or equal to 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])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
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])
Calcitonin measurement
Item
screening calcitonin value 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 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])
Medical contraindication Liraglutide | Medical contraindication Sitagliptin | Medical contraindication Metformin
Item
any contraindications to liraglutide, sitagliptin or metformin according to local labelling
boolean
C1301624 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1565750 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])