Body mass index
Item
body mass index > or = to 25 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c > or =7% and < or =10% at screening.
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg > or = 7.0mmol/l (126mg/dl) at visit 2.
boolean
C0583513 (UMLS CUI [1])
Metformin Dose Constant
Item
receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1948059 (UMLS CUI [1,3])
Gender Contraceptive methods | Postmenopausal state
Item
female subjects must be postmenopausal or using effective contraceptive measures.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
Antidiabetics Oral | Metformin
Item
use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
Edema Clinical Significance Requirement Pharmacotherapy | Edema Requirement Pharmacotherapy
Item
subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
boolean
C0013604 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,4])
C0013604 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013216 (UMLS CUI [2,3])
Hypoglycemia Severe
Item
subjects with a history of severe hypoglycaemia.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Disease | Renal dysfunction
Item
renal disease or renal dysfunction.
boolean
C0022658 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
Liver disease Clinical Significance
Item
presence of clinically significant hepatic disease.
boolean
C0023895 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Angina, Unstable | Angina Pectoris Severe | Congestive heart failure | New York Heart Association Classification
Item
presence of unstable or severe angina or known nyha grade i-iv congestive heart failure.
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident
Item
subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
boolean
C0027051 (UMLS CUI [1])
C2936173 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0038454 (UMLS CUI [4])