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ID

18446

Beschrijving

AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00359112

Link

https://clinicaltrials.gov/show/NCT00359112

Trefwoorden

  1. 05-11-16 05-11-16 -
Geüploaded op

5 november 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00359112

    Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00359112

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    body mass index > or = to 25 kg/m2.
    Beschrijving

    Body mass index

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    hba1c > or =7% and < or =10% at screening.
    Beschrijving

    Glycosylated hemoglobin A

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    fpg > or = 7.0mmol/l (126mg/dl) at visit 2.
    Beschrijving

    Plasma fasting glucose measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0583513
    receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
    Beschrijving

    Metformin Dose Constant

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1948059
    female subjects must be postmenopausal or using effective contraceptive measures.
    Beschrijving

    Gender Contraceptive methods | Postmenopausal state

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2]
    C0232970
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
    Beschrijving

    Antidiabetics Oral | Metformin

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0935929
    UMLS CUI [1,2]
    C1527415
    UMLS CUI [2]
    C0025598
    subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
    Beschrijving

    Edema Clinical Significance Requirement Pharmacotherapy | Edema Requirement Pharmacotherapy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013604
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [1,3]
    C1514873
    UMLS CUI [1,4]
    C0013216
    UMLS CUI [2,1]
    C0013604
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0013216
    subjects with a history of severe hypoglycaemia.
    Beschrijving

    Hypoglycemia Severe

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020615
    UMLS CUI [1,2]
    C0205082
    renal disease or renal dysfunction.
    Beschrijving

    Kidney Disease | Renal dysfunction

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    UMLS CUI [2]
    C3279454
    presence of clinically significant hepatic disease.
    Beschrijving

    Liver disease Clinical Significance

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C2826293
    presence of unstable or severe angina or known nyha grade i-iv congestive heart failure.
    Beschrijving

    Angina, Unstable | Angina Pectoris Severe | Congestive heart failure | New York Heart Association Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0002965
    UMLS CUI [2,1]
    C0002962
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3]
    C0018802
    UMLS CUI [4]
    C1275491
    subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
    Beschrijving

    Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C2936173
    UMLS CUI [3]
    C0010055
    UMLS CUI [4]
    C0038454

    Similar models

    Eligibility Non-Insulin-Dependent Diabetes Mellitus NCT00359112

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Body mass index
    Item
    body mass index > or = to 25 kg/m2.
    boolean
    C1305855 (UMLS CUI [1])
    Glycosylated hemoglobin A
    Item
    hba1c > or =7% and < or =10% at screening.
    boolean
    C0019018 (UMLS CUI [1])
    Plasma fasting glucose measurement
    Item
    fpg > or = 7.0mmol/l (126mg/dl) at visit 2.
    boolean
    C0583513 (UMLS CUI [1])
    Metformin Dose Constant
    Item
    receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
    boolean
    C0025598 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1948059 (UMLS CUI [1,3])
    Gender Contraceptive methods | Postmenopausal state
    Item
    female subjects must be postmenopausal or using effective contraceptive measures.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Antidiabetics Oral | Metformin
    Item
    use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
    boolean
    C0935929 (UMLS CUI [1,1])
    C1527415 (UMLS CUI [1,2])
    C0025598 (UMLS CUI [2])
    Edema Clinical Significance Requirement Pharmacotherapy | Edema Requirement Pharmacotherapy
    Item
    subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
    boolean
    C0013604 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [1,3])
    C0013216 (UMLS CUI [1,4])
    C0013604 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0013216 (UMLS CUI [2,3])
    Hypoglycemia Severe
    Item
    subjects with a history of severe hypoglycaemia.
    boolean
    C0020615 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Kidney Disease | Renal dysfunction
    Item
    renal disease or renal dysfunction.
    boolean
    C0022658 (UMLS CUI [1])
    C3279454 (UMLS CUI [2])
    Liver disease Clinical Significance
    Item
    presence of clinically significant hepatic disease.
    boolean
    C0023895 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Angina, Unstable | Angina Pectoris Severe | Congestive heart failure | New York Heart Association Classification
    Item
    presence of unstable or severe angina or known nyha grade i-iv congestive heart failure.
    boolean
    C0002965 (UMLS CUI [1])
    C0002962 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0018802 (UMLS CUI [3])
    C1275491 (UMLS CUI [4])
    Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident
    Item
    subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
    boolean
    C0027051 (UMLS CUI [1])
    C2936173 (UMLS CUI [2])
    C0010055 (UMLS CUI [3])
    C0038454 (UMLS CUI [4])

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