Informed Consent
Item
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject.)
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length | Insulin naive
Item
insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
Antidiabetics Oral Quantity | Metformin | Sulfonylurea | Insulin Releasing Pills | repaglinide | nateglinide | alpha-Glucosidase Inhibitors Dose Stable
Item
treatment with one or two oral anti-diabetic drugs (oads): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved summary of product characteristics (spc)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C1283071 (UMLS CUI [4,2])
C0994475 (UMLS CUI [4,3])
C0246689 (UMLS CUI [5])
C0903898 (UMLS CUI [6])
C1299007 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
Glucohemoglobin measurement
Item
hba1c, 7.0 - 11.0 % (both inclusive)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi), 25.0 - 37.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Medical contraindication Metformin
Item
metformin contraindication according to local practice
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Thiazolidinediones
Item
thiazolidinedione (tzd) treatments within the previous three months prior to visit 1
boolean
C1257987 (UMLS CUI [1])
Systemic therapy Interferes with Glucose metabolism | Systemic therapy Interferes with Lipid Metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
boolean
C1515119 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0598783 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
Disease Clinical Significance Interferes with Research results | Disease Clinical Significance At risk Investigational New Drugs | Gastrointestinal Diseases | Lung diseases | Nervous system disorder | Disorder of the genitourinary system | Hematological Disease
Item
subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the investigator, 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])
C1444641 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0080276 (UMLS CUI [6])
C0018939 (UMLS CUI [7])