Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (visit 1)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
insulin detemir times/day | Insulin Glargine times/day | NPH insulin times/day
Item
current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, nph for at least 3 months prior to the screening visit (visit 1)
boolean
C0537270 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0907402 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0021658 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
Metformin Dose unchanged | Metformin Dose Minimum | Combined Modality Therapy | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors
Item
current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (su) or glinide or dipeptidyl peptidase-iv inhibitors and/or alpha-glucosidase inhibitors (agi) with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
Hemoglobin A1c measurement | Metformin | Antidiabetics Oral | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors
Item
hba1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (oad) (sulphonylurea (su), glinide, dipeptidyl peptidase-iv (ddp-iv) inhibitors, alpha-glucosidase inhibitors (agi) combination group at the screening visit (visit 1)
boolean
C0474680 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
Body mass index
Item
body mass index (bmi) equal or less than 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Bolus Insulin use | Exception Insulin use short-term | Etiology Comorbidity
Item
any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (visit 1)
boolean
C0240016 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0240016 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
GLP-1 Receptor Agonist | Thiazolidinediones
Item
use of glucagon-like peptide-1 (glp-1) agonists and/or thiazolidinediones (tzd) within the last 3 months prior to screening (visit 1)
boolean
C2917359 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1)
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])