Insulin Glargine | Antidiabetics Oral Dose Stable | Antidiabetics Oral Absent | Metformin | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | pioglitazone
Item
current treatment with iglar (insulin glargine) with or without oads (oral antidiabetic drug). all antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of oads should have been stable in this period of time. - please note that a maximum of 3 oads are allowed during this trial: metformin, sulphonylurea (su)/glinides, dipeptidyl peptidase 4 (dpp-iv) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
boolean
C0907402 (UMLS CUI [1])
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])
C0332197 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C2917254 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C0071097 (UMLS CUI [9])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of t2dm (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (screening visit)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-9.5% (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) equal to or below 35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease At risk Protocol Compliance | Disease Severe At risk Protocol Compliance
Item
any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to visit 1 (screening visit)
boolean
C0038454 (UMLS CUI [1])
C0581377 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0162577 (UMLS CUI [6])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dl for males and higher than or equal to 1.3 mg/dl for females
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Hypoglycemic Agents | Exception Inclusion criteria
Item
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])