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ID

35801

Description

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms; ODM derived from: https://clinicaltrials.gov/show/NCT02298192

Lien

https://clinicaltrials.gov/show/NCT02298192

Mots-clés

Versions (1)
  1. 24/03/2019 24/03/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

24 mars 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Diabetes NCT02298192

    Anglais

    Eligibility Diabetes NCT02298192

    1 Formulaires  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02298192
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    type 2 diabetes mellitus
    Description

    Diabetes Mellitus, Non-Insulin-Dependent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    male or female equal to or above 18 years of age
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    hba1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
    Description

    Hemoglobin A1c measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
    Description

    Metformin Stable U/day | Metformin Maximum Tolerated Dose | Pioglitazone Dosage | Pioglitazone Absent

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [1,3]
    C0456683
    UMLS CUI [2,1]
    C0025598
    UMLS CUI [2,2]
    C0752079
    UMLS CUI [3,1]
    C0071097
    UMLS CUI [3,2]
    C0178602
    UMLS CUI [4,1]
    C0071097
    UMLS CUI [4,2]
    C0332197
    body mass index (bmi) below or equal to 40 kg/m^2
    Description

    Body mass index

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
    Description

    Antidiabetics | Exception Metformin | Exception Pioglitazone | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0935929
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0025598
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0071097
    UMLS CUI [4,1]
    C0580105
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C0596620
    UMLS CUI [5]
    C3653708
    previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
    Description

    Insulin regime | Exception Therapeutic procedure short-term Comorbidity | Exception Therapeutic procedure short-term Gestational Diabetes

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0557978
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C0443303
    UMLS CUI [2,4]
    C0009488
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0087111
    UMLS CUI [3,3]
    C0443303
    UMLS CUI [3,4]
    C0085207
    treatment with glucagon-like peptide-1 (glp-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (dpp-4) inhibitors or sodium-glucose co-transporter 2 (sglt2) inhibitors within 90 days prior to the screening visit
    Description

    GLP-1 Receptor Agonist | Sulfonylurea | Glinide | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2917359
    UMLS CUI [2]
    C0038766
    UMLS CUI [3]
    C2266929
    UMLS CUI [4]
    C3537225
    UMLS CUI [5]
    C3273807
    impaired liver function, defined as alanine aminotransferase (alat) above or equal to 2.5 times upper normal range (unr)
    Description

    Liver Dysfunction | Alanine aminotransferase increased

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C0151905
    impaired renal function defined as serum-creatinine above or equal to 133 micromol/l (above or equal to 1.5 mg/dl) for males and above or equal to 125 micromol/l (above or equal to 1.4 mg/dl) for females, or as defined according to local contraindications for metformin
    Description

    Renal Insufficiency | Creatinine measurement, serum | Gender

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0201976
    UMLS CUI [3]
    C0079399
    screening calcitonin above or equal to 50 ng/l
    Description

    Calcitonin measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201924
    proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
    Description

    Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for | Macular retinal edema Treatment required for

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0339467
    UMLS CUI [1,2]
    C0332121
    UMLS CUI [2,1]
    C0730362
    UMLS CUI [2,2]
    C0332121
    UMLS CUI [3,1]
    C0271051
    UMLS CUI [3,2]
    C0332121
    personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0238462
    UMLS CUI [2]
    C1833921
    UMLS CUI [3,1]
    C0027662
    UMLS CUI [3,2]
    C0332307
    history of pancreatitis (acute or chronic)
    Description

    Pancreatitis | Pancreatitis, Chronic

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0030305
    UMLS CUI [2]
    C0149521
    Retour au début de la page

    Similar models

    Eligibility Diabetes NCT02298192

    1 Formulaires
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02298192
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent
    Item
    type 2 diabetes mellitus
    boolean
    C0011860 (UMLS CUI [1])
    Age
    Item
    male or female equal to or above 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Hemoglobin A1c measurement
    Item
    hba1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
    boolean
    C0474680 (UMLS CUI [1])
    Metformin Stable U/day | Metformin Maximum Tolerated Dose | Pioglitazone Dosage | Pioglitazone Absent
    Item
    stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
    boolean
    C0025598 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0456683 (UMLS CUI [1,3])
    C0025598 (UMLS CUI [2,1])
    C0752079 (UMLS CUI [2,2])
    C0071097 (UMLS CUI [3,1])
    C0178602 (UMLS CUI [3,2])
    C0071097 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    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 | Exception Metformin | Exception Pioglitazone | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
    Item
    current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
    boolean
    C0935929 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0025598 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0071097 (UMLS CUI [3,2])
    C0580105 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C0596620 (UMLS CUI [4,3])
    C3653708 (UMLS CUI [5])
    Insulin regime | Exception Therapeutic procedure short-term Comorbidity | Exception Therapeutic procedure short-term Gestational Diabetes
    Item
    previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
    boolean
    C0557978 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C0443303 (UMLS CUI [2,3])
    C0009488 (UMLS CUI [2,4])
    C1705847 (UMLS CUI [3,1])
    C0087111 (UMLS CUI [3,2])
    C0443303 (UMLS CUI [3,3])
    C0085207 (UMLS CUI [3,4])
    GLP-1 Receptor Agonist | Sulfonylurea | Glinide | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor
    Item
    treatment with glucagon-like peptide-1 (glp-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (dpp-4) inhibitors or sodium-glucose co-transporter 2 (sglt2) inhibitors within 90 days prior to the screening visit
    boolean
    C2917359 (UMLS CUI [1])
    C0038766 (UMLS CUI [2])
    C2266929 (UMLS CUI [3])
    C3537225 (UMLS CUI [4])
    C3273807 (UMLS CUI [5])
    Liver Dysfunction | Alanine aminotransferase increased
    Item
    impaired liver function, defined as alanine aminotransferase (alat) above or equal to 2.5 times upper normal range (unr)
    boolean
    C0086565 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    Renal Insufficiency | Creatinine measurement, serum | Gender
    Item
    impaired renal function defined as serum-creatinine above or equal to 133 micromol/l (above or equal to 1.5 mg/dl) for males and above or equal to 125 micromol/l (above or equal to 1.4 mg/dl) for females, or as defined according to local contraindications for metformin
    boolean
    C1565489 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    C0079399 (UMLS CUI [3])
    Calcitonin measurement
    Item
    screening calcitonin above or equal to 50 ng/l
    boolean
    C0201924 (UMLS CUI [1])
    Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for | Macular retinal edema Treatment required for
    Item
    proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
    boolean
    C0339467 (UMLS CUI [1,1])
    C0332121 (UMLS CUI [1,2])
    C0730362 (UMLS CUI [2,1])
    C0332121 (UMLS CUI [2,2])
    C0271051 (UMLS CUI [3,1])
    C0332121 (UMLS CUI [3,2])
    Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
    Item
    personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
    boolean
    C0238462 (UMLS CUI [1])
    C1833921 (UMLS CUI [2])
    C0027662 (UMLS CUI [3,1])
    C0332307 (UMLS CUI [3,2])
    Pancreatitis | Pancreatitis, Chronic
    Item
    history of pancreatitis (acute or chronic)
    boolean
    C0030305 (UMLS CUI [1])
    C0149521 (UMLS CUI [2])
    Retour au début de la page 

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