Informed consent
Item
1. provision of informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Maximum Dosage Stable
Item
2. 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])
C0806909 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Age
Item
3. male or female age ≧ 18 years and ≦70 years old
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c ≧7.0 and ≦10%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
5. bmi ≧ 24 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Related Pharmaceutical Preparations
Item
1. 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])
C0013230 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
Renal Insufficiency | Creatinine measurement, serum
Item
2. impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Disease Causing Tissue hypoxia | Respiratory Failure | Shock
Item
3. acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C4061096 (UMLS CUI [1,3])
C1145670 (UMLS CUI [2])
C0036974 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement | Acute alcoholic intoxication | Alcoholic Intoxication, Chronic
Item
4. abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.
boolean
C0086565 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0394996 (UMLS CUI [5])
C0001973 (UMLS CUI [6])
Cardiovascular Diseases Clinical Significance | Myocardial Infarction | Cardiac Arrhythmia | Electrocardiography Conduction delay | Angina, Unstable | Decompensated cardiac failure
Item
5. 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 | Muscular edema Requirement Therapeutic procedure
Item
6. proliferative retinopathy or muscular oedema requiring acute treatment.
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C4021979 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier
Item
7. 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
8. treatment with systemic corticosteroids within the past two months prior to screening.
boolean
C0087111 (UMLS CUI [1,1])
C2825233 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
9. type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Investigational New Drugs Use
Item
10. receipt of any investigational drug within 1 month prior to this trial.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])