Informed Consent
Item
informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
boolean
C0021430 (UMLS CUI [1])
Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Glinide | Metformin | alpha-Glucosidase Inhibitors | Thiazolidinediones | Diet therapy | Exercise | Cumulative Dose Daily unchanged | Pharmaceutical Preparations Type unchanged
Item
japanese subjects with type 2 diabetes on monotherapy with an oad (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved japanese labelling in addition to diet and exercise therapy. total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to visit 1
boolean
C1556094 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C2266929 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1257987 (UMLS CUI [7])
C0012159 (UMLS CUI [8])
C0015259 (UMLS CUI [9])
C2986497 (UMLS CUI [10,1])
C0332173 (UMLS CUI [10,2])
C0442739 (UMLS CUI [10,3])
C0013227 (UMLS CUI [11,1])
C0332307 (UMLS CUI [11,2])
C0442739 (UMLS CUI [11,3])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c between 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Outpatients | Absence Hospitalization Education Glycaemia control
Item
outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. however, hospitalisation for training of self-injection from visit 2 that is for no longer than one week is allowed
boolean
C0029921 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0030688 (UMLS CUI [2,3])
C3267174 (UMLS CUI [2,4])
Plasma Glucose Measurement Self Perform
Item
subjects able and willing to perform self-monitoring of plasma glucose (smpg)
boolean
C0202042 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
Malignant Neoplasms | Recurrence Suspected | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0034897 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Calcitonin measurement
Item
calcitonin above or equal to 160 pg/ml
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid
Item
personal history of non-familial medullary thyroid carcinoma
boolean
C0238462 (UMLS CUI [1])
Family history of multiple endocrine neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma
Item
family or personal history of multiple endocrine neoplasia type 2 (men-2) or familial medullary thyroid carcinoma (fmtc)
boolean
C4039247 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0027662 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors
Item
treatment with glp-1 receptor agonist or dipeptidyl peptidase 4 (dpp-4) inhibitor within 12 weeks prior to visit 1
boolean
C2917359 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
Medical contraindication Liraglutide | Medical contraindication Antidiabetics Oral
Item
having contraindications to liraglutide and any of the oads (according to japanese labelling)
boolean
C1301624 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])