Age | Informed Consent | Japan
Item
male or female, age at least 18 years at the time of signing inform consent. for japan: male or female, age at least 20 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0022341 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Stable | Basal insulin Dosage | Insulin Glargine | Insulin detemir | Insulin degludec | Insulin, isophane | Combined Modality Therapy | Metformin U/day | Metformin Maximum Tolerated Dose
Item
subjects diagnosed with t2dm (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 iu/kg/day and/or 20 iu/day of: insulin glargine, insulin detemir, insulin degludec and/or nph insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0650607 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0907402 (UMLS CUI [4])
C0537270 (UMLS CUI [5])
C3491971 (UMLS CUI [6])
C0021658 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
C0025598 (UMLS CUI [9,1])
C0456683 (UMLS CUI [9,2])
C0025598 (UMLS CUI [10,1])
C0752079 (UMLS CUI [10,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive
boolean
C0474680 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy | Vaginal contraceptive diaphragm | Male Condom Partner | 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 throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). germany: only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. japan: adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
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])
C1657106 (UMLS CUI [5])
C1656586 (UMLS CUI [6])
C0009906 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0009653 (UMLS CUI [12,1])
C0682323 (UMLS CUI [12,2])
C0183461 (UMLS CUI [13])
C0087145 (UMLS CUI [14])
C0009905 (UMLS CUI [15])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Bolus Insulin short-term | Exception Bolus Insulin Comorbidity
Item
treatment with any glucose lowering agents 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 bolus 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])
C1705509 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
C0443303 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1705509 (UMLS CUI [4,2])
C0021641 (UMLS CUI [4,3])
C0009488 (UMLS CUI [4,4])
Episode Quantity Hypoglycemia Severe | Loss of hypoglycemic warning
Item
experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (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 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Renal Insufficiency Severe | Renal function GFR estimation by MDRD
Item
severe renal impairment defined as egfr (estimated glomerular filtration rate) below 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1,1])
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 (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])