Gender | Postmenopausal state | Age
Item
male or postmenopausal female ≥ 40 years of age at visit 1
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent
Item
documentation of type 2 diabetes mellitus as evidenced by one or more of the following criteria:
boolean
C0011860 (UMLS CUI [1])
Symptoms Typical | Blood glucose measurement
Item
1. with typical symptoms and random blood sugar ≥ 200 mg/dl
boolean
C1457887 (UMLS CUI [1,1])
C3538928 (UMLS CUI [1,2])
C0392201 (UMLS CUI [2])
Fasting blood glucose measurement Hour Quantity
Item
2. 8-hour fasting blood sugar ≥ 126 mg/dl
boolean
C0428568 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Oral Glucose Tolerance Test
Item
3. oral glucose tolerance test ≥ 200 mg/dl
boolean
C0029161 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c≥ 6.5%
boolean
C0474680 (UMLS CUI [1])
Antidiabetics Oral | Exception Thiazolidinediones | Exception Dipeptidyl-Peptidase IV Inhibitors | Hemoglobin A1c measurement
Item
only receiving oral anti-diabetic drugs (excluding tzds or dpp-4 inhibitors) till visit 1 at least 3 months, and the hba1c is between 7.0~8.5 % in recent 3 months.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1257987 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1827106 (UMLS CUI [3,2])
C0474680 (UMLS CUI [4])
Informed Consent | Informed Consent Patient Representative | Protocol Compliance
Item
written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Diabetes Mellitus | Antidiabetics Oral
Item
dm on oral anti-diabetic drugs less than 3 months.
boolean
C0011849 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors
Item
receiving treatment of tzds or dpp-4 inhibitors prior to this study.
boolean
C1257987 (UMLS CUI [1])
C1827106 (UMLS CUI [2])
Condition compromises Patient safety | Abnormality compromises Patient safety | Condition compromises Data Quality | Abnormality compromises Data Quality
Item
presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0242483 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0242483 (UMLS CUI [4,3])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast, alt over 2.5 times of the upper limit.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Chronic kidney disease stage
Item
chronic kidney disease, stage 4 and 5.
boolean
C2074731 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure, nyha class iii, iv
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Osteoporosis T score
Item
history of osteoporosis. (t score < -2.5)
boolean
C0029456 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Vitamin D, 25-hydroxy measurement
Item
serum 25(oh)vit d < 20ng/ml
boolean
C0373558 (UMLS CUI [1])
Disease Affecting Bone metabolism
Item
any diseases known to affect bone metabolism:
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
Thyroid function tests abnormal | Hyperthyroidism | Cushing Syndrome | Hypogonadism | Acromegaly | Hypopituitarism | Status post Pituitary gland surgery | Status post Therapeutic radiology procedure | Hematological Disease
Item
abnormal thyroid function or history of hyperthyroidism, cushing's syndrome, hypogonadism, acromegaly, history of hypopituitarism or status post pituitary surgery and/or radiotherapy, hematopoietic disorders.
boolean
C0476414 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
C0010481 (UMLS CUI [3])
C0020619 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
C0020635 (UMLS CUI [6])
C0231290 (UMLS CUI [7,1])
C0871087 (UMLS CUI [7,2])
C0231290 (UMLS CUI [8,1])
C1522449 (UMLS CUI [8,2])
C0018939 (UMLS CUI [9])
Diabetic macular edema
Item
diabetic macular edema (dme).
boolean
C0730285 (UMLS CUI [1])
Diabetic Retinopathy Moderate | Diabetic Retinopathy Severe
Item
moderate to severe diabetic retinopathy.
boolean
C0011884 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0011884 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Fracture of lumbar spine | Fracture Hip Joint | Fracture Head of femur | Fracture of forearm | Therapy Fracture Site Any
Item
history of fracture over lumbar spine or hip joint or femoral head or forearm or any site of bone fracture undergoes treatment currently.
boolean
C0262544 (UMLS CUI [1])
C0016658 (UMLS CUI [2,1])
C0019558 (UMLS CUI [2,2])
C0016658 (UMLS CUI [3,1])
C0015813 (UMLS CUI [3,2])
C1305215 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C0016658 (UMLS CUI [5,2])
C1515974 (UMLS CUI [5,3])
C1552551 (UMLS CUI [5,4])
Pharmaceutical Preparations Intake Before Screening
Item
who had taken any of the following medications prior to screening:
boolean
C0013227 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Adrenal Cortex Hormones | heparin | Anticonvulsants | Aluminum-based antacid | Proton Pump Inhibitors | Immunosuppressive Agents | Diphosphonates | Fluoride Systemic therapy | Phenytoin Analogue | Calcitonin | denosumab | strontium ranelate | Hormone replacement therapy | Androgens | Estrogens | Progesterone | thyroxine | Growth Hormone | Selective Estrogen Receptor Modulators | Tamoxifen | Raloxifene | tibolone | Aromatase Inhibitors
Item
corticosteroid, heparin, anticonvulsants, aluminum-containing antacid, proton pump inhibitor, immunosuppressant user within 3 months. bisphosphonate, systemic fluoride treatment, pht analogue, calcitonin, denosumab, strontium ranelate, hormone replacement therapy (androgen/estrogen/progesterone, thyroxine, growth hormone), selective estrogen receptor modulator /serm (tamoxifene, raloxifene), selective tissue estrogenic activity regulator /stear (tibolone), aromatase inhibitors within 1 year.
boolean
C0001617 (UMLS CUI [1])
C0019134 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C0304540 (UMLS CUI [4])
C0358591 (UMLS CUI [5])
C0021081 (UMLS CUI [6])
C0012544 (UMLS CUI [7])
C0016327 (UMLS CUI [8,1])
C1515119 (UMLS CUI [8,2])
C0031507 (UMLS CUI [9,1])
C0243071 (UMLS CUI [9,2])
C0006668 (UMLS CUI [10])
C1690432 (UMLS CUI [11])
C0936139 (UMLS CUI [12])
C0282402 (UMLS CUI [13])
C0002844 (UMLS CUI [14])
C0014939 (UMLS CUI [15])
C0033308 (UMLS CUI [16])
C0040165 (UMLS CUI [17])
C0037663 (UMLS CUI [18])
C0732611 (UMLS CUI [19])
C0039286 (UMLS CUI [20])
C0244404 (UMLS CUI [21])
C0076660 (UMLS CUI [22])
C0593802 (UMLS CUI [23])
Malignant Neoplasms
Item
history of cancer.
boolean
C0006826 (UMLS CUI [1])
Patients Bed-ridden
Item
bed-ridden patients.
boolean
C0030705 (UMLS CUI [1,1])
C0425251 (UMLS CUI [1,2])