criteria Following Fulfill
Item
for inclusion in the study subjects should fulfill the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed consent
Item
provision of informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dosage Maximum Stable
Item
type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Age
Item
male or female age ≧ 25 years and ≦75 years old
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≧7.0 and ≦9.5%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≧ 20 and ≦ 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Exclusion Criteria Following Fulfill
Item
subjects should not enter the study if any of the following exclusion criteria are fulfilled:
boolean
C0680251 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related
Item
known or suspected allergy to trial products or related products.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
Renal Insufficiency | Creatinine measurement, serum
Item
impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 132.6 μmol/l).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Disease Causing Tissue hypoxia | Heart failure | Respiratory Failure | Shock
Item
acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C4061096 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2])
C1145670 (UMLS CUI [3])
C0036974 (UMLS CUI [4])
Hepatic Insufficiency | Acute alcoholic intoxication | Alcoholic Intoxication, Chronic
Item
hepatic insufficiency, acute alcohol intoxication, alcoholism.
boolean
C1306571 (UMLS CUI [1])
C0394996 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
Cardiovascular Diseases Clinical Significance | Myocardial Infarction | Cardiac Arrhythmia | Electrocardiography Conduction delay | Angina, Unstable | Decompensated cardiac failure
Item
subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (mi), arrhythmias or conduction delays on ecg, unstable angina, or decompensated heart failure (new york heart association-class ⅲ and ⅳ).
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C1623258 (UMLS CUI [4,1])
C1398354 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
C0581377 (UMLS CUI [6])
Proliferative retinopathy Requirement Therapeutic procedure acute | Muscular edema Requirement Therapeutic procedure acute
Item
proliferative retinopathy or muscular oedema requiring acute treatment.
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205178 (UMLS CUI [1,4])
C4021979 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0205178 (UMLS CUI [2,4])
Lactation
Item
lactation.
boolean
C0022925 (UMLS CUI [1])
Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier
Item
pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Therapeutic procedure systemic steroids
Item
treatment with systemic corticosteroids within the past two months prior to screening.
boolean
C0087111 (UMLS CUI [1,1])
C2825233 (UMLS CUI [1,2])
serum glutamic acid decarboxylase (GAD) antibody test Positive
Item
tested positive for glutamic acid decarboxylase antibody.
boolean
C2208796 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Investigational New Drug Use
Item
receipt of any investigational drug within 1 month prior to this trial.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])