Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Metformin | Sulfonylurea | pioglitazone | Combined Modality Therapy | Kidney Failure Moderate | Basal insulin | Premixed insulin
Item
subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: monotherapy or any duo-combinations of metformin and/or sus and/or pioglitazone. metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. or monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
boolean
C0011860 (UMLS CUI [1])
C3274787 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0071097 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C0035078 (UMLS CUI [7,1])
C0205081 (UMLS CUI [7,2])
C0650607 (UMLS CUI [8])
C2069057 (UMLS CUI [9])
Hemoglobin A1c measurement
Item
hba1c 7-10% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Renal Insufficiency Moderate | Renal function GFR estimation by MDRD
Item
moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an egfr (glomerular filtration rate) of 30-59 ml/min/1.73 m2 per mdrd (modification of diet in renal disease) formula at the screening visit
boolean
C1565489 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) 20-45 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Antidiabetics | Exception Inclusion criteria | Insulin regime short-term allowed | Insulin, Short-Acting | Relationship Comorbidity
Item
treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3,1])
C0443303 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0356365 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0009488 (UMLS CUI [5,2])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alat (alanine aminotransferase) above or equal to 2.5 times upper normal limit
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Episode of Unstable Angina | Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiovascular event | Arrhythmia by ECG Finding | Conduction delay ECG
Item
within the past 180 days any of the following: episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ecg (electrocardiogram))
boolean
C0332189 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C1320716 (UMLS CUI [5])
C3831474 (UMLS CUI [6])
C1398354 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
Heart failure New York Heart Association Classification
Item
heart failure defined as new york heart association (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Systolic Pressure | Diastolic blood pressure
Item
a systolic blood pressure above or equal to 180 mmhg or a diastolic blood pressure above or equal to 100 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
RENAL DISEASE PROGRESSIVE Rapidly | Acute glomerulonephritis
Item
rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
boolean
C0748293 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0156221 (UMLS CUI [2])
Therapeutic immunosuppression
Item
use of immunosuppressive treatment within 90 days prior to screening
boolean
C0021079 (UMLS CUI [1])
Malignant Neoplasms | Cancer treatment | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])