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ID

15277

Description

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01620424

Lien

https://clinicaltrials.gov/show/NCT01620424

Mots-clés

  1. 24/05/2016 24/05/2016 -
Téléchargé le

24 mai 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Diabetes NCT01620424

    Eligibility Diabetes NCT01620424

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01620424
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    type 2 diabetes
    Description

    type 2 diabetes

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    duration of diabetes for at least 1 year
    Description

    duration of diabetes

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0872146
    UMLS CUI [1,2]
    C0011860
    body mass index (bmi) maximum 30.0 kg/m^2
    Description

    BMI

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    hba1c maximum 10.0%
    Description

    hba1c

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    recurrent severe hypoglycaemia
    Description

    hypoglycaemia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0020615
    proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
    Description

    retinopathy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0035309
    impaired hepatic function
    Description

    impaired hepatic function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    impaired renal function
    Description

    impaired renal function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    cardiac problems
    Description

    cardiac problems

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0262402
    uncontrolled treated / untreated hypertension
    Description

    hypertension

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
    Description

    hepatitis antigens

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019168
    UMLS CUI [2]
    C0166049
    UMLS CUI [3]
    C0019686
    total daily insulin dose exceeding 40 iu
    Description

    insulin dose

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021641
    treatment with ohas (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
    Description

    ohas

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0359086
    treatment with ohas or insulin preparations once a day later than noon
    Description

    ohas or insulin preparations

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0359086
    UMLS CUI [2]
    C0021641
    subjects who smoke more than 15 cigarettes per day
    Description

    smoking

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0543414

    Similar models

    Eligibility Diabetes NCT01620424

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01620424
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    type 2 diabetes
    Item
    type 2 diabetes
    boolean
    C0011860 (UMLS CUI [1])
    duration of diabetes
    Item
    duration of diabetes for at least 1 year
    boolean
    C0872146 (UMLS CUI [1,1])
    C0011860 (UMLS CUI [1,2])
    BMI
    Item
    body mass index (bmi) maximum 30.0 kg/m^2
    boolean
    C1305855 (UMLS CUI [1])
    hba1c
    Item
    hba1c maximum 10.0%
    boolean
    C0019018 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    hypoglycaemia
    Item
    recurrent severe hypoglycaemia
    boolean
    C0020615 (UMLS CUI [1])
    retinopathy
    Item
    proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
    boolean
    C0035309 (UMLS CUI [1])
    impaired hepatic function
    Item
    impaired hepatic function
    boolean
    C0232741 (UMLS CUI [1])
    impaired renal function
    Item
    impaired renal function
    boolean
    C0232804 (UMLS CUI [1])
    cardiac problems
    Item
    cardiac problems
    boolean
    C0262402 (UMLS CUI [1])
    hypertension
    Item
    uncontrolled treated / untreated hypertension
    boolean
    C0020538 (UMLS CUI [1])
    hepatitis antigens
    Item
    hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
    boolean
    C0019168 (UMLS CUI [1])
    C0166049 (UMLS CUI [2])
    C0019686 (UMLS CUI [3])
    insulin dose
    Item
    total daily insulin dose exceeding 40 iu
    boolean
    C0021641 (UMLS CUI [1])
    ohas
    Item
    treatment with ohas (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
    boolean
    C0359086 (UMLS CUI [1])
    ohas or insulin preparations
    Item
    treatment with ohas or insulin preparations once a day later than noon
    boolean
    C0359086 (UMLS CUI [1])
    C0021641 (UMLS CUI [2])
    smoking
    Item
    subjects who smoke more than 15 cigarettes per day
    boolean
    C0543414 (UMLS CUI [1])

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