Age | Informed Consent
Item
male or female, 18 years or older at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Insulin Absent | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Sulfonylurea | Combined Modality Therapy
Item
insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and su (metformin 1500 mg or higher or maximum tolerated dose and su half of maximum allowed dose according to national label or higher) for at least 90 days before screening. stable is defined as unchanged medication and unchanged dose
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
C3274787 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C0038766 (UMLS CUI [6])
C0009429 (UMLS CUI [7])
Hemoglobin A1c measurement
Item
hba1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
boolean
C0474680 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
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])
Disease At risk Patient safety | Disease Protocol Compliance At risk
Item
any disorder which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity
Item
treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less 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 or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value greater than 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 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])
Renal Insufficiency Severe | Renal function GFR estimation by MDRD
Item
severe renal impairment defined as estimated glomerular filtration rate (egfr) less than 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident
Item
acute coronary or cerebrovascular event within 90 days before randomisation
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
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])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
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])
Mental handicap Excludes Comprehension Study Protocol | Mental handicap Excludes Protocol Compliance | Study Protocol Comprehension Unwilling | Protocol Compliance Unwilling | Language Barriers Exclude Comprehension Study Protocol | Language Barriers Exclude Protocol Compliance
Item
mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C1306341 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C2348563 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0237167 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0162340 (UMLS CUI [5,3])
C2348563 (UMLS CUI [5,4])
C0237167 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])