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ID

17250

Beschrijving

AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00241605

Link

https://clinicaltrials.gov/show/NCT00241605

Trefwoorden

  1. 02-09-16 02-09-16 -
Geüploaded op

2 september 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Diabetes Mellitus, Type 2 NCT00241605

    Eligibility Diabetes Mellitus, Type 2 NCT00241605

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients between 18 and 75 years of age with type 2 diabetes mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
    Beschrijving

    Age | Diabetes Mellitus, Non-Insulin-Dependent | Metformin Glycaemia control

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0011860
    UMLS CUI [3,1]
    C0025598
    UMLS CUI [3,2]
    C3267174
    patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
    Beschrijving

    Thiazolidinediones stopped | Antidiabetics stopped

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1257987
    UMLS CUI [1,2]
    C1272691
    UMLS CUI [2,1]
    C0935929
    UMLS CUI [2,2]
    C1272691
    women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
    Beschrijving

    Gender | Postmenopausal state | Female Sterilization | Contraceptive methods

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0232970
    UMLS CUI [3]
    C0015787
    UMLS CUI [4]
    C0700589
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
    Beschrijving

    HEPATOCELLULAR REACTION Thiazolidinediones Use | Severe edema Associated with Thiazolidinediones Use

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0518991
    UMLS CUI [1,2]
    C1257987
    UMLS CUI [1,3]
    C1524063
    UMLS CUI [2,1]
    C0341950
    UMLS CUI [2,2]
    C0332281
    UMLS CUI [2,3]
    C1257987
    UMLS CUI [2,4]
    C1524063
    have a known hypersensitivity to thiazolidinediones or biguanides.
    Beschrijving

    Hypersensitivity Thiazolidinediones | Hypersensitivity Biguanides

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1257987
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0005382
    currently using insulin or any oral anti-diabetic agent other than metformin.
    Beschrijving

    Insulin | Oral hypoglycemic | Metformin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021641
    UMLS CUI [2]
    C0359086
    UMLS CUI [3]
    C0025598
    history of metabolic acidosis.
    Beschrijving

    Metabolic acidosis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0220981
    history of substance abuse.
    Beschrijving

    Substance Use Disorders

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    have active cancer other than localized squamous or basal cell carcinoma.
    Beschrijving

    Malignant Neoplasms | Squamous cell carcinoma Localized | Basal cell carcinoma Localized

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C0007137
    UMLS CUI [2,2]
    C0392752
    UMLS CUI [3,1]
    C0007117
    UMLS CUI [3,2]
    C0392752
    chronic disease requiring treatment with corticosteroids.
    Beschrijving

    Chronic disease Requirement Adrenal Cortex Hormones

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008679
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0001617
    other criteria will be evaluated at the screening visit.
    Beschrijving

    criteria Evaluation Screening

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C1261322
    UMLS CUI [1,3]
    C0220908

    Similar models

    Eligibility Diabetes Mellitus, Type 2 NCT00241605

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Diabetes Mellitus, Non-Insulin-Dependent | Metformin Glycaemia control
    Item
    patients between 18 and 75 years of age with type 2 diabetes mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
    boolean
    C0001779 (UMLS CUI [1])
    C0011860 (UMLS CUI [2])
    C0025598 (UMLS CUI [3,1])
    C3267174 (UMLS CUI [3,2])
    Thiazolidinediones stopped | Antidiabetics stopped
    Item
    patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
    boolean
    C1257987 (UMLS CUI [1,1])
    C1272691 (UMLS CUI [1,2])
    C0935929 (UMLS CUI [2,1])
    C1272691 (UMLS CUI [2,2])
    Gender | Postmenopausal state | Female Sterilization | Contraceptive methods
    Item
    women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
    boolean
    C0079399 (UMLS CUI [1])
    C0232970 (UMLS CUI [2])
    C0015787 (UMLS CUI [3])
    C0700589 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    HEPATOCELLULAR REACTION Thiazolidinediones Use | Severe edema Associated with Thiazolidinediones Use
    Item
    prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
    boolean
    C0518991 (UMLS CUI [1,1])
    C1257987 (UMLS CUI [1,2])
    C1524063 (UMLS CUI [1,3])
    C0341950 (UMLS CUI [2,1])
    C0332281 (UMLS CUI [2,2])
    C1257987 (UMLS CUI [2,3])
    C1524063 (UMLS CUI [2,4])
    Hypersensitivity Thiazolidinediones | Hypersensitivity Biguanides
    Item
    have a known hypersensitivity to thiazolidinediones or biguanides.
    boolean
    C0020517 (UMLS CUI [1,1])
    C1257987 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0005382 (UMLS CUI [2,2])
    Insulin | Oral hypoglycemic | Metformin
    Item
    currently using insulin or any oral anti-diabetic agent other than metformin.
    boolean
    C0021641 (UMLS CUI [1])
    C0359086 (UMLS CUI [2])
    C0025598 (UMLS CUI [3])
    Metabolic acidosis
    Item
    history of metabolic acidosis.
    boolean
    C0220981 (UMLS CUI [1])
    Substance Use Disorders
    Item
    history of substance abuse.
    boolean
    C0038586 (UMLS CUI [1])
    Malignant Neoplasms | Squamous cell carcinoma Localized | Basal cell carcinoma Localized
    Item
    have active cancer other than localized squamous or basal cell carcinoma.
    boolean
    C0006826 (UMLS CUI [1])
    C0007137 (UMLS CUI [2,1])
    C0392752 (UMLS CUI [2,2])
    C0007117 (UMLS CUI [3,1])
    C0392752 (UMLS CUI [3,2])
    Chronic disease Requirement Adrenal Cortex Hormones
    Item
    chronic disease requiring treatment with corticosteroids.
    boolean
    C0008679 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0001617 (UMLS CUI [1,3])
    criteria Evaluation Screening
    Item
    other criteria will be evaluated at the screening visit.
    boolean
    C0243161 (UMLS CUI [1,1])
    C1261322 (UMLS CUI [1,2])
    C0220908 (UMLS CUI [1,3])

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