Japan | Age | Informed Consent
Item
for japan only: male or female, age above or equal to 20 years at the time of signing inform consent
boolean
C0022341 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise
Item
subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral, Hormonal | Hormonal contraception Injectable | Hormonal contraception Implantable | Intrauterine Devices | Intrauterine System | Contraception, Barrier | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Male sterilization | Sexual Abstinence
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and 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. united kingdom: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0009907 (UMLS CUI [5])
C2985296 (UMLS CUI [6,1])
C1828121 (UMLS CUI [6,2])
C2985296 (UMLS CUI [7,1])
C0021102 (UMLS CUI [7,2])
C0021900 (UMLS CUI [8])
C4293370 (UMLS CUI [9])
C0004764 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
C0493327 (UMLS CUI [12])
C3843415 (UMLS CUI [13])
C0024559 (UMLS CUI [14])
C0036899 (UMLS CUI [15])
Chronic disease compromises Patient safety | Disease Severe compromises Patient safety | Chronic disease compromises Protocol Compliance | Disease Severe compromises Protocol Compliance
Item
any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Hypoglycemic Agents | Exception Insulin regime short-term Comorbidity
Item
treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. an exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
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 above or equal to 50 ng/l (pg/ml)
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as egfr (epidermal growth factor receptor ) below 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1])
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])