Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin regime | Basal insulin | Premixed insulin | Basal insulin Bolus | Diet therapy | Exercise | Insulin Cumulative Dose U/day
Item
current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (i)u/day
boolean
C0557978 (UMLS CUI [1])
C0650607 (UMLS CUI [2])
C2069057 (UMLS CUI [3])
C0650607 (UMLS CUI [4,1])
C1705509 (UMLS CUI [4,2])
C0012159 (UMLS CUI [5])
C0015259 (UMLS CUI [6])
C0021641 (UMLS CUI [7,1])
C2986497 (UMLS CUI [7,2])
C0456683 (UMLS CUI [7,3])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 7.5 and 11.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (mao) inhibitors
boolean
C0580105 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0026457 (UMLS CUI [4])
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 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 according to the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
GLP-1 Receptor Agonist
Item
treatment with glucagon-like peptide-1 (glp-1) receptor agonist within 12 weeks prior to screening
boolean
C2917359 (UMLS CUI [1])
Antidiabetics Oral
Item
treatment with any oral antidiabetic drugs (oads) within 12 weeks prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])