Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Premixed insulin times per day | Human Insulin Mixed Self times per day | Short-Acting Insulin Percentage | Combined Modality Therapy | Metformin | alpha-Glucosidase Inhibitors | alpha-Glucosidase Inhibitors Absent | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Acarbose U/day | Miglitol U/day | Voglibose U/day
Item
currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) bid (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (visit 1) with the minimum dose stated: metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to visit 1) or alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
boolean
C2069057 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0795635 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0036588 (UMLS CUI [2,3])
C0439511 (UMLS CUI [2,4])
C0356365 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0009429 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1299007 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0025598 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0456683 (UMLS CUI [8,3])
C0025598 (UMLS CUI [9,1])
C0752079 (UMLS CUI [9,2])
C0050393 (UMLS CUI [10,1])
C0456683 (UMLS CUI [10,2])
C0066535 (UMLS CUI [11,1])
C0456683 (UMLS CUI [11,2])
C0532578 (UMLS CUI [12,1])
C0456683 (UMLS CUI [12,2])
Insulin Cumulative Dose U/day
Item
total daily insulin dose below 1.4 iu/kg
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Pills Releasing Insulin | Thiazolidinediones | Dipeptidyl Peptidase 4 Inhibitors | GLP-1 Receptor Agonist
Item
treatment with any insulin secretagogue, thiazolidinedione (tzd), dipeptidyl peptidase-4 (dpp-4) inhibitors and glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to visit 1
boolean
C0994475 (UMLS CUI [1,1])
C1283071 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C1257987 (UMLS CUI [2])
C2917254 (UMLS CUI [3])
C2917359 (UMLS CUI [4])
Insulin Intensification therapy | Premixed insulin times per day | Basal insulin Bolus | Continuous subcutaneous infusion of insulin
Item
previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (csii)) for more than 14 days
boolean
C0021641 (UMLS CUI [1,1])
C1511484 (UMLS CUI [1,2])
C2069057 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0650607 (UMLS CUI [3,1])
C1705509 (UMLS CUI [3,2])
C0393124 (UMLS CUI [4])
Insulin use times per day Previous | Exception Premixed insulin | Exception Human Insulin Self Mixed | Exception Short-Acting Insulin Percentage
Item
previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) bid within 3 month prior to visit 1
boolean
C0240016 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2069057 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0795635 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
C0036588 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0356365 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, 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])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])