Age | Informed Consent
Item
male or female, age at least 20 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin a1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Study Subject Japanese | Treatment Stable Non-Insulin-Dependent Diabetes Mellitus | Diet therapy | Exercise | Antidiabetics Oral | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | Thiazolidinediones
Item
japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before visit 1 (week -2). or b) on oad monotherapy (either of su (sulfonylurea), glinide, a-gi (a-glucosidase inhibitor) or tzd (thiazolidinediones)) within approved japanese labelling in addition to diet and exercise therapy for at least 60 days before visit 1 (week -2)
boolean
C0681850 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0038766 (UMLS CUI [6])
C2266929 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | Vaginal Spermicides | Contraceptives, Oral
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
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])
C0036899 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0009653 (UMLS CUI [7,1])
C0682323 (UMLS CUI [7,2])
C0021900 (UMLS CUI [8])
C0183461 (UMLS CUI [9])
C0087145 (UMLS CUI [10])
C0009905 (UMLS CUI [11])
Hypoglycemic Agents | Exception Inclusion criteria | GLP-1 Receptor Agonist times/week | Exception Insulin regime short-term Comorbidity
Item
treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days before visit 1 (week -2). an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C2917359 (UMLS CUI [3,1])
C0456698 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0557978 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
C0009488 (UMLS CUI [4,4])
Disease compromises Patient safety | Disease compromises Protocol Compliance
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])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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 (mtc) or multiple endocrine neoplasia syndrome type 2 (men2)
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 estimated glomerular filtration rate (egfr) 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 (visit 2 [week 0])
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])