Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Hypoglycaemic episode Severe Quantity | Chronic Kidney Failure Moderate | Glomerular Filtration Rate | Loss of hypoglycemic warning | Exposure to Insulin | Episode of Hypoglycemia | Symptoms Hypoglycemia | Episode Glucose low
Item
subjects fulfilling at least one of the below criteria: a) experienced at least one severe hypoglycaemic episode within last year (according to the ada (american diabetes association) definition, april 2013), b) moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 ml/min/1.73 m^2 per ckd-epi (chronic kidney disease epidemiology collaboration) by central laboratory analysis, c) hypoglycaemic symptom unawareness, d) exposed to insulin for more than 5 years, e) recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dl [below or equal to 3.9 mmol/l])) within the last 12 weeks prior to visit 1 (screening)
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0022661 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3])
C0342317 (UMLS CUI [4])
C0332157 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C0332189 (UMLS CUI [6,1])
C0020615 (UMLS CUI [6,2])
C1457887 (UMLS CUI [7,1])
C0020615 (UMLS CUI [7,2])
C0332189 (UMLS CUI [8,1])
C0860801 (UMLS CUI [8,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to visit 1
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin | Antidiabetics Oral | Combined Modality Therapy | Metformin | Dipeptidyl Peptidase-4 Inhibitor | alpha-Glucosidase Inhibitors | Thiazolidinediones | SGLT2 Inhibitor
Item
current treatment with any basal insulin (od or bid) ± any combination of oads (metformin, dpp-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and sglt2-inhibitor) for 26 weeks or longer prior to visit 1 for subjects on bid the total daily dose should be below 75 units
boolean
C0650607 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C3537225 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1257987 (UMLS CUI [7])
C3273807 (UMLS CUI [8])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) below or equal to 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Bolus Insulin | Insulin Product Mixed
Item
treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to visit 1
boolean
C1705509 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C0205430 (UMLS CUI [2,3])
Antidiabetics | Exception Inclusion criteria
Item
use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to visit 1
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])