ID

14105

Descripción

Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01507311

Link

https://clinicaltrials.gov/show/NCT01507311

Palabras clave

  1. 29/3/16 29/3/16 -
Subido en

29 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Diabetes NCT01507311

    Eligibility Diabetes NCT01507311

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01507311
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current oha (oral hypoglycaemic agent) treatment with stable dose for at least six months
    Descripción

    Type 2 diabetes and treatment

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0011860 (Diabetes Mellitus, Non-Insulin-Dependent)
    SNOMED
    44054006
    UMLS CUI [2]
    C0011878 (Diabetic Diet)
    SNOMED
    160670007
    UMLS CUI [3]
    C0359086 (oral hypoglycemics)
    bmi (body mass index) between 24 and 35 kg/m^2 (both inclusive)
    Descripción

    BMI

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
    Descripción

    Fasting plasma glucose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0583513 (Plasma fasting glucose measurement)
    SNOMED
    167096006
    anti-gad (glutamic acid decarboxylase) negative
    Descripción

    Anti-gad

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1167898 (Anti-GAD antibody negative)
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    known or suspected allergy to trial product or related products
    Descripción

    Allergy to trial product

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C3854006 (clinical trial drug)
    receipt of any investigational drug within three months prior to this trial
    Descripción

    Experimental drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0304229 (Experimental drug)
    recurrent severe hypoglycaemia as judged by the investigator
    Descripción

    Recurrent severe hypoglycaemia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0342316 (Recurrent severe hypoglycemia)
    SNOMED
    237636001
    cardiac disease or any clinically significant abnormal ecg (electrocardiogram)
    Descripción

    Cardiac disease or ECG

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    UMLS CUI [2]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    use of any drug (except oral hypoglycaemic agents (ohas)) which in the investigator's opinion could interfere
    Descripción

    Pharmacotherapy and drug interactions

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    UMLS CUI [1,2]
    C0687133 (Drug Interactions)
    SNOMED
    404204005
    with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
    Descripción

    Medication interferring with blood glucose level

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0392201 (Blood glucose measurement)
    SNOMED
    33747003
    UMLS CUI [1,2]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    UMLS CUI [1,3]
    C0687133 (Drug Interactions)
    SNOMED
    404204005
    liver or renal disease
    Descripción

    Liver or renal disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI [2]
    C0022658 (Kidney Diseases)
    SNOMED
    90708001

    Similar models

    Eligibility Diabetes NCT01507311

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01507311
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Type 2 diabetes and treatment
    Item
    diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current oha (oral hypoglycaemic agent) treatment with stable dose for at least six months
    boolean
    C0011860 (UMLS CUI [1])
    C0011878 (UMLS CUI [2])
    C0359086 (UMLS CUI [3])
    BMI
    Item
    bmi (body mass index) between 24 and 35 kg/m^2 (both inclusive)
    boolean
    C1305855 (UMLS CUI [1])
    Fasting plasma glucose
    Item
    fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
    boolean
    C0583513 (UMLS CUI [1])
    Anti-gad
    Item
    anti-gad (glutamic acid decarboxylase) negative
    boolean
    C1167898 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Allergy to trial product
    Item
    known or suspected allergy to trial product or related products
    boolean
    C0020517 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Experimental drugs
    Item
    receipt of any investigational drug within three months prior to this trial
    boolean
    C0304229 (UMLS CUI [1])
    Recurrent severe hypoglycaemia
    Item
    recurrent severe hypoglycaemia as judged by the investigator
    boolean
    C0342316 (UMLS CUI [1])
    Cardiac disease or ECG
    Item
    cardiac disease or any clinically significant abnormal ecg (electrocardiogram)
    boolean
    C0018799 (UMLS CUI [1])
    C0013798 (UMLS CUI [2])
    Pharmacotherapy and drug interactions
    Item
    use of any drug (except oral hypoglycaemic agents (ohas)) which in the investigator's opinion could interfere
    boolean
    C0013216 (UMLS CUI [1,1])
    C0687133 (UMLS CUI [1,2])
    Medication interferring with blood glucose level
    Item
    with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
    boolean
    C0392201 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C0687133 (UMLS CUI [1,3])
    Liver or renal disease
    Item
    liver or renal disease
    boolean
    C0023895 (UMLS CUI [1])
    C0022658 (UMLS CUI [2])

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