ID

35803

Beschrijving

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02420262

Link

https://clinicaltrials.gov/show/NCT02420262

Trefwoorden

Versies (1)
  1. 24-03-19 24-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Diabetes NCT02420262

    Engels

    Eligibility Diabetes NCT02420262

    1 Formulieren  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02420262
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    male or female, age at least 18 years at the time of signing informed consent
    Beschrijving

    Age | Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0021430
    type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
    Beschrijving

    Diabetes Mellitus, Non-Insulin-Dependent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    hba1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
    Beschrijving

    Hemoglobin A1c measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    current treatment with iglar (insulin glargine) for at least 90 calendar days prior to screening
    Beschrijving

    Insulin Glargine

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0907402
    stable daily dose of iglar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
    Beschrijving

    Insulin Glargine Daily Dose Stable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0907402
    UMLS CUI [1,2]
    C2348070
    UMLS CUI [1,3]
    C0205360
    stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
    Beschrijving

    Metformin Daily Dose Stable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598
    UMLS CUI [1,2]
    C2348070
    UMLS CUI [1,3]
    C0205360
    body mass index (bmi) below or equal to 40 kg/m^2
    Beschrijving

    Body mass index

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
    Beschrijving

    Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0935929
    UMLS CUI [2]
    C0376607
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1512693
    anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
    Beschrijving

    Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Weight-Loss Agents | sibutramine | orlistat | Thyroid Hormones | Adrenal Cortex Hormones

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0005910
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0596620
    UMLS CUI [3]
    C0376606
    UMLS CUI [4]
    C0074493
    UMLS CUI [5]
    C0076275
    UMLS CUI [6]
    C0040135
    UMLS CUI [7]
    C0001617
    impaired liver function, defined as alanine aminotransferase (alt) at least 2.5 times upper limit of normal
    Beschrijving

    Liver Dysfunction | Alanine aminotransferase increased

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C0151905
    renal impairment egfr (electronic case report form) below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology collaboration)
    Beschrijving

    Renal Insufficiency | Estimated Glomerular Filtration Rate

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C3811844
    screening calcitonin at least 50 ng/l
    Beschrijving

    Calcitonin measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201924
    history of pancreatitis (acute or chronic)
    Beschrijving

    Pancreatitis | Pancreatitis, Chronic

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0030305
    UMLS CUI [2]
    C0149521
    personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
    Beschrijving

    Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0238462
    UMLS CUI [2]
    C1833921
    UMLS CUI [3,1]
    C0027662
    UMLS CUI [3,2]
    C0332307
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    Similar models

    Eligibility Diabetes NCT02420262

    1 Formulieren
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02420262
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Informed Consent
    Item
    male or female, age at least 18 years at the time of signing informed consent
    boolean
    C0001779 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Diabetes Mellitus, Non-Insulin-Dependent
    Item
    type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
    boolean
    C0011860 (UMLS CUI [1])
    Hemoglobin A1c measurement
    Item
    hba1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
    boolean
    C0474680 (UMLS CUI [1])
    Insulin Glargine
    Item
    current treatment with iglar (insulin glargine) for at least 90 calendar days prior to screening
    boolean
    C0907402 (UMLS CUI [1])
    Insulin Glargine Daily Dose Stable
    Item
    stable daily dose of iglar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
    boolean
    C0907402 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Metformin Daily Dose Stable
    Item
    stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
    boolean
    C0025598 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Body mass index
    Item
    body mass index (bmi) below or equal to 40 kg/m^2
    boolean
    C1305855 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria
    Item
    treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
    boolean
    C0935929 (UMLS CUI [1])
    C0376607 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C1512693 (UMLS CUI [3,2])
    Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Weight-Loss Agents | sibutramine | orlistat | Thyroid Hormones | Adrenal Cortex Hormones
    Item
    anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0005910 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0596620 (UMLS CUI [2,3])
    C0376606 (UMLS CUI [3])
    C0074493 (UMLS CUI [4])
    C0076275 (UMLS CUI [5])
    C0040135 (UMLS CUI [6])
    C0001617 (UMLS CUI [7])
    Liver Dysfunction | Alanine aminotransferase increased
    Item
    impaired liver function, defined as alanine aminotransferase (alt) at least 2.5 times upper limit of normal
    boolean
    C0086565 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    Renal Insufficiency | Estimated Glomerular Filtration Rate
    Item
    renal impairment egfr (electronic case report form) below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology collaboration)
    boolean
    C1565489 (UMLS CUI [1])
    C3811844 (UMLS CUI [2])
    Calcitonin measurement
    Item
    screening calcitonin at least 50 ng/l
    boolean
    C0201924 (UMLS CUI [1])
    Pancreatitis | Pancreatitis, Chronic
    Item
    history of pancreatitis (acute or chronic)
    boolean
    C0030305 (UMLS CUI [1])
    C0149521 (UMLS CUI [2])
    Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
    Item
    personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
    boolean
    C0238462 (UMLS CUI [1])
    C1833921 (UMLS CUI [2])
    C0027662 (UMLS CUI [3,1])
    C0332307 (UMLS CUI [3,2])
    Terug naar het begin van de pagina 

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