Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes mellitus at least 3 months prior to visit 1 (week -2)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin U/day | Antidiabetics Oral Dose Stable | Antidiabetics Oral Maximum Tolerated Dose | Antidiabetics Oral Absent
Item
treatment with at least 1000 mg metformin per day with/without other oads at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to visit 1
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0752079 (UMLS CUI [3,3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Insulin Absent
Item
insulin-naïve subjects
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c above or equal to 7.5% by central laboratory analysis
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])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Investigational New Drugs
Item
the receipt of any investigational product within 4 weeks prior to visit 1
boolean
C0013230 (UMLS CUI [1])
Medical contraindication Insulin detemir
Item
any contraindication to insulin detemir according to the domestic labelling
boolean
C1301624 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
Systemic therapy Dose Change | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase [mao] inhibitors)
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])
C0304516 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
Disease Interferes with Research results | Disease 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])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any conditions that the investigator judges would interfere with trial participation or evaluation of the 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])