Age
Item
male and female patients, 18-70 years of age.
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Obesity | Body mass index | Abnormality Following
Item
diagnosis of type 2 diabetes treated with metformin and obesity (body mass index [bmi] >30 kg/m^2) and the following other abnormalities:
boolean
C0087111 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C0028754 (UMLS CUI [3])
C1305855 (UMLS CUI [4])
C1704258 (UMLS CUI [5,1])
C0332282 (UMLS CUI [5,2])
Obesity, Abdominal | Waist Circumference | Gender
Item
abdominal obesity (waist circumference >102 cm in men and >88 cm in women). according to national cholesterol education program-adult treatment panel (ncep-atp) iii (2001).
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Glycosylated hemoglobin A | Hypoglycemia Significant | Adverse effects Due to Therapeutic procedure | Diabetes Mellitus Short duration | Life Expectancy Long | Cardiovascular Disease Significant Absent
Item
glycated hemoglobin a1c (hba1c) ≥7 and ≤8.5% (after sponsor approval providers might reasonably suggest more stringent a1c goals [such as 6.5%] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease).
boolean
C0019018 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0879626 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0011849 (UMLS CUI [4,1])
C0439593 (UMLS CUI [4,2])
C0023671 (UMLS CUI [5,1])
C0205166 (UMLS CUI [5,2])
C0007222 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Hypertriglyceridemia | Serum fasting triglyceride measurement | Serum total cholesterol measurement | Dyslipidemias Primitive
Item
hypertriglyceridemia (fasting triglyceride levels between 150 mg/dl and 600 mg/dl, cholesterol <300 mg/dl. in order to exclude patients who might be suffering from a primitive dyslipidemia).
boolean
C0020557 (UMLS CUI [1])
C0582824 (UMLS CUI [2])
C1445957 (UMLS CUI [3])
C0242339 (UMLS CUI [4,1])
C3645627 (UMLS CUI [4,2])
Decreased HDL cholesterol | Serum HDL cholesterol measurement | Gender
Item
low high-density lipoprotein (hdl) cholesterol (serum hdl-cholesterol <40 mg/dl in men and <50 mg/dl in women).
boolean
C0151691 (UMLS CUI [1])
C0428472 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Smoking | Thyroid Diseases | Hormone replacement therapy | Antithyroid Agents | Thyroid stimulating hormone measurement | Hypothyroidism Symptoms Clinical
Item
smoking. thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (thyroid stimulating hormone [tsh] >5 mu/l with clinical symptoms of hypothyroidism).
boolean
C0037369 (UMLS CUI [1])
C0040128 (UMLS CUI [2])
C0282402 (UMLS CUI [3])
C0040125 (UMLS CUI [4])
C0202230 (UMLS CUI [5])
C0020676 (UMLS CUI [6,1])
C1457887 (UMLS CUI [6,2])
C0205210 (UMLS CUI [6,3])
Liver diseases | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
hepatic disease (aspartate aminotransferase [asat] or alanine aminotransferase [alat] >2 times the upper limit of normal).
boolean
C0023895 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Kidney Diseases | Creatinine measurement, serum | Coronary heart disease | Cerebrovascular Disorders | Peripheral Arterial Diseases
Item
renal disease (serum creatinine >1.7 times the upper limit of normal). a history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment.
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C1704436 (UMLS CUI [5])
Malignant Neoplasms | Lipid-lowering therapy | Systolic Pressure | Diastolic blood pressure | Triglycerides measurement | Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of malignancies. use of lipid lowering therapy. systolic blood pressure ≥180 mmhg and/or diastolic blood pressure ≥110 mmhg. triglycerides >600 mg/dl. history of chronic pancreatitis or of idiopathic acute pancreatitis.
boolean
C0006826 (UMLS CUI [1])
C0585943 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
C0202236 (UMLS CUI [5])
C0149521 (UMLS CUI [6])
C0341461 (UMLS CUI [7])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])