Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes prior to informed consent
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise
Item
male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
Antidiabetics Absent
Item
drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antidiabetics Oral Quantity | Sulfonylurea | Antidiabetics Dose Stable | Thiazolidinediones unchanged | Antidiabetics Specific To be stopped
Item
pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). individual antidiabetic drug will have to be discontinued at visit 1.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1257987 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C0205369 (UMLS CUI [5,2])
C1272691 (UMLS CUI [5,3])
Glycosylated hemoglobin A
Item
haemoglobin a1c (hba1c) at visit 1 (screening)
boolean
C0019018 (UMLS CUI [1])
Hemoglobin A1c measurement | Antidiabetics Absent
Item
for patients without antidiabetic therapy : hba1c >=8.0 to =<10.5%
boolean
C0474680 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hemoglobin A1c measurement | Antidiabetics Oral Quantity
Item
for patients with one oral antidiabetic drug : hba1c >=7.5 to =<10.5%
boolean
C0474680 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hemoglobin A1c measurement | Randomization Double-Blind Method
Item
hba1c >=7.5 to =<10.0% at visit 4 for randomisation into the double blind treatment period
boolean
C0474680 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0013072 (UMLS CUI [2,2])
Hyperglycemia Uncontrolled | Glucose level
Item
uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/l) during the open label stabilisation period and placebo run in period
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function, defined as estimated glomerular filtration rate (egfr) <45 ml/min/1.73m2 (modification of diet in renal disease (mdrd) formula)
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
acute coronary syndrome, stroke or transient ischemic attack (tia) within 12 weeks prior to informed consent
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
indication of liver disease, defined by serum levels of either alanine transaminase (alt), aspartate transaminase (ast), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln)
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])