Age | Gender
Item
age and gender eligibility: 30 years and older
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Sulfonylurea Dose Stable | Combined Modality Therapy
Item
patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the screening visit
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3])
Glucohemoglobin measurement
Item
patients must have hba1c level between 7.0-10.0 %, inclusively at screening
boolean
C0202054 (UMLS CUI [1])
Obesity, Abdominal | Waist Circumference | Ethnic group | Caucasoid | Gender | South Asian | Chinese
Item
the participant must have central obesity (waist circumference) defined per country/ethnic group: europids: men ≥ 94 cm, women ≥ 80 cm; south asian, chinese &
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0015031 (UMLS CUI [3])
C0007457 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C1519427 (UMLS CUI [6])
C0152035 (UMLS CUI [7])
Waist Circumference | Japanese | Gender | Metabolic Syndrome Characteristics Quantity
Item
japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:
boolean
C0455829 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0524620 (UMLS CUI [4,1])
C1521970 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Decreased HDL cholesterol
Item
reduced hdl cholesterol ≤ 1.0 mmol/l
boolean
C0151691 (UMLS CUI [1])
Hypertriglyceridemia | Therapeutic procedure Dyslipidemia
Item
hypertriglyceridemia ≥ 1.7 mmol/l or treatment for dyslipidemia
boolean
C0020557 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
Hypertensive disease | Blood pressure determination | Antihypertensive Agents
Item
hypertension: ≥ 130/85 mm hg blood pressure or treatment with antihypertensive medication.
boolean
C0020538 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C0003364 (UMLS CUI [3])
Glomerular Filtration Rate | Dialysis Absent
Item
patients must have a glomerular filtration rate (gfr) of ≥ 60 ml/min, and no history of dialysis.
boolean
C0017654 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Insulin | Thiazolidinediones | Hypoglycemic Agents | Exception Metformin | Exception Sulfonylurea
Item
patients having received insulin, thiazolidinediones (tzds) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C0020616 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
Heart Disease | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Congestive heart failure New York Heart Association Classification | Myocardial Ischemia Severe
Item
has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (ptca), congestive heart failure (new york heart association class iii-iv), or severe ischemic disease
boolean
C0018799 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C2936173 (UMLS CUI [6])
C0018802 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
C0151744 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
Red blood cell count raised | Thalassemia | Anemia
Item
patients who have an increased red blood cell (rbc) turn-over or thalassemia or anemia
boolean
C0427458 (UMLS CUI [1])
C0039730 (UMLS CUI [2])
C0002871 (UMLS CUI [3])
HIV Infection | Hepatitis B | Hepatitis C
Item
known hiv or history of viral hepatitis type b or c.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Diabetes type Any | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
any type of diabetes other than type 2 diabetes
boolean
C1320657 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Elevated liver enzymes
Item
significant hepatic enzyme elevation
boolean
C0235996 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of > 40kg/m2
boolean
C1305855 (UMLS CUI [1])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable | Condition Requirement Adrenal Cortex Hormones
Item
current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0001617 (UMLS CUI [3,3])