Japanese | Age | Informed Consent
Item
male or female japanese subjects at least 20 years of age at the time of informed consent
boolean
C1556094 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c 7.5-10.0 % [58 mmol/mol-86 mmol/mol] (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Antidiabetics Oral Stable
Item
subjects on stable therapy with one oad (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved japanese labelling
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Insulin regime Previous | Exception Therapy short-term Comorbidity | Exception Therapy short-term Gestational Diabetes
Item
previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)
boolean
C0557978 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0085207 (UMLS CUI [3,4])
Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria
Item
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
boolean
C0935929 (UMLS CUI [1])
C0376607 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
Calcitonin measurement
Item
screening calcitonin equal or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C0241889 (UMLS CUI [4,1])
C0027662 (UMLS CUI [4,2])
C0332307 (UMLS CUI [4,3])
New York Heart Association Classification
Item
subjects presently classified as being in new york heart association (nyha) class iv
boolean
C1275491 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack
Item
within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0007787 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Polyps | Exception Carcinoma in Situ
Item
diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
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])
C1705847 (UMLS CUI [4,1])
C0032584 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
Condition compromises Patient safety | Condition compromises Protocol Compliance
Item
any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])