Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Treatment Stable | Metformin Cumulative Dose U/day | Metformin Maximum Tolerated Dose | Antidiabetics Oral Quantity | Antidiabetics Oral Absent | Sulfonylureas | Meglitinides | Thiazolidinediones | Dipeptidyl Peptidase 4 Inhibitors
Item
stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other oad (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (dpp-4) inhibitors) for at least 3 months
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0038766 (UMLS CUI [6])
C1579432 (UMLS CUI [7])
C1257987 (UMLS CUI [8])
C2917254 (UMLS CUI [9])
Insulin Absent | Insulin regime short-term allowed
Item
subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) less than or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Medical contraindication insulin detemir | Medical contraindication Insulin Glargine
Item
any contraindication to insulin detemir or insulin glargine according to the local labelling
boolean
C1301624 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
Investigational New Drugs
Item
receipt of any investigational product within 4 weeks
boolean
C0013230 (UMLS CUI [1])
Systemic therapy Dose Change | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
boolean
C1515119 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
Disease Clinical Significance Interferes with Research results | Disease Clinical Significance Investigational New Drugs At risk
Item
clinically significant diseases which, in the investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any other condition that the investigator feels would interfere with trial participation or evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])