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ID

16096

Description

Safety and Efficacy of Saxagliptin vs.Glimepiride as Add-on Therapy in T2DM Patients With Metformin Monotherapytients; ODM derived from: https://clinicaltrials.gov/show/NCT02280486

Link

https://clinicaltrials.gov/show/NCT02280486

Keywords

Versions (1)
  1. 6/29/16 6/29/16 -
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June 29, 2016

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Creative Commons BY 4.0
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    Eligibility Type 2 Diabetes NCT02280486

    English

    Eligibility Type 2 Diabetes NCT02280486

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    for inclusion in the study subjects should fulfill the following criteria:
    Description

    criteria Following Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C1550543
    provision of informed consent prior to any study specific procedures
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
    Description

    Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dosage Maximum Stable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    UMLS CUI [2,1]
    C0025598
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0806909
    UMLS CUI [2,4]
    C0205360
    male or female age ≧ 25 years and ≦75 years old
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    hba1c ≧7.0 and ≦9.5%
    Description

    Hemoglobin A1c measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    bmi ≧ 20 and ≦ 30 kg/m2
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subjects should not enter the study if any of the following exclusion criteria are fulfilled:
    Description

    Exclusion Criteria Following Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C1550543
    known or suspected allergy to trial products or related products.
    Description

    Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0013227
    UMLS CUI [2,3]
    C0013230
    UMLS CUI [2,4]
    C0439849
    impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 132.6 μmol/l).
    Description

    Renal Insufficiency | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0201976
    acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
    Description

    Disease Causing Tissue hypoxia | Heart failure | Respiratory Failure | Shock

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C4061096
    UMLS CUI [2]
    C0018801
    UMLS CUI [3]
    C1145670
    UMLS CUI [4]
    C0036974
    hepatic insufficiency, acute alcohol intoxication, alcoholism.
    Description

    Hepatic Insufficiency | Acute alcoholic intoxication | Alcoholic Intoxication, Chronic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1306571
    UMLS CUI [2]
    C0394996
    UMLS CUI [3]
    C0001973
    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).
    Description

    Cardiovascular Diseases Clinical Significance | Myocardial Infarction | Cardiac Arrhythmia | Electrocardiography Conduction delay | Angina, Unstable | Decompensated cardiac failure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2]
    C0027051
    UMLS CUI [3]
    C0003811
    UMLS CUI [4,1]
    C1623258
    UMLS CUI [4,2]
    C1398354
    UMLS CUI [5]
    C0002965
    UMLS CUI [6]
    C0581377
    proliferative retinopathy or muscular oedema requiring acute treatment.
    Description

    Proliferative retinopathy Requirement Therapeutic procedure acute | Muscular edema Requirement Therapeutic procedure acute

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0339467
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [1,4]
    C0205178
    UMLS CUI [2,1]
    C4021979
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0087111
    UMLS CUI [2,4]
    C0205178
    lactation.
    Description

    Lactation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0022925
    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).
    Description

    Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0240802
    UMLS CUI [3]
    C0006147
    UMLS CUI [4,1]
    C0700589
    UMLS CUI [4,2]
    C0558080
    UMLS CUI [5]
    C0015787
    UMLS CUI [6]
    C0021900
    UMLS CUI [7]
    C0009905
    UMLS CUI [8]
    C0004764
    treatment with systemic corticosteroids within the past two months prior to screening.
    Description

    Therapeutic procedure systemic steroids

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2825233
    tested positive for glutamic acid decarboxylase antibody.
    Description

    serum glutamic acid decarboxylase (GAD) antibody test Positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2208796
    UMLS CUI [1,2]
    C1446409
    receipt of any investigational drug within 1 month prior to this trial.
    Description

    Investigational New Drug Use

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C1524063
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    Similar models

    Eligibility Type 2 Diabetes NCT02280486

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    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])
    Item Group
    C0680251 (UMLS CUI)
    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])
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