Non-Insulin-Dependent Diabetes Mellitus Disease length | Basal insulin Analogue Dose U/day | Metformin Dose Stable U/day | Metformin Absent
Item
diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 u/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin a1c) 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) 20-45 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy intended
Item
female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Hypoglycaemic episode Severe Recurrent | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0342317 (UMLS CUI [2])
Hypoglycemic Agents | Exception Inclusion criteria
Item
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Liver Dysfunction | Renal Insufficiency
Item
impaired liver or renal function
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated or untreated hypertension (systolic blood pressure (sbp) equal to or above 180 mmhg and/or diastolic blood pressure (dbp) equal to or above 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus
Item
any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0011860 (UMLS CUI [2,4])
Alcohol abuse | Alcohol abuse Suspected | Narcotic Abuse | Narcotic Abuse Suspected
Item
known or suspected abuse of alcohol or narcotics
boolean
C0085762 (UMLS CUI [1])
C0085762 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0524661 (UMLS CUI [3])
C0524661 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])