ID

35815

Descrizione

A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02453685

collegamento

https://clinicaltrials.gov/show/NCT02453685

Keywords

versioni (1)
  1. 25/03/19 25/03/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

25 marzo 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Diabetes NCT02453685

    Inglese

    Eligibility Diabetes NCT02453685

    1 moduli  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02453685
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
    Descrizione

    Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    male or female, age at least 18 years at the time of signing informed consent
    Descrizione

    Age

    Tipo di dati

    boolean

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

    Non-Insulin-Dependent Diabetes Mellitus Disease length

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0011860
    UMLS CUI [1,2]
    C0872146
    treatment with stable daily dose (for at least 90 days prior to screening) of: -
    Descrizione

    Therapy Daily Dose Stable

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2348070
    UMLS CUI [1,3]
    C0205360
    metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, dpp4i (dipeptidyl peptidase-4 inhibitor), sglt2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
    Descrizione

    Metformin Dosage | Metformin Maximum Tolerated Dose | Sulfonylurea | Antidiabetics Oral To be stopped | Pills Insulin Releasing To be stopped | Dipeptidyl Peptidase-4 Inhibitor To be stopped | Sodium-Glucose Cotransporter 2 Inhibitor To be stopped | Colesevelam To be stopped | Bromocriptine To be stopped | Combination Product To be stopped

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2,1]
    C0025598
    UMLS CUI [2,2]
    C0752079
    UMLS CUI [3]
    C0038766
    UMLS CUI [4,1]
    C0935929
    UMLS CUI [4,2]
    C1527415
    UMLS CUI [4,3]
    C1272691
    UMLS CUI [5,1]
    C0994475
    UMLS CUI [5,2]
    C0021641
    UMLS CUI [5,3]
    C1283071
    UMLS CUI [5,4]
    C1272691
    UMLS CUI [6,1]
    C3537225
    UMLS CUI [6,2]
    C1272691
    UMLS CUI [7,1]
    C3542461
    UMLS CUI [7,2]
    C1272691
    UMLS CUI [8,1]
    C0541155
    UMLS CUI [8,2]
    C1272691
    UMLS CUI [9,1]
    C0006230
    UMLS CUI [9,2]
    C1272691
    UMLS CUI [10,1]
    C1880146
    UMLS CUI [10,2]
    C1272691
    insulin-naïve. short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
    Descrizione

    Insulin Absent | Insulin regime short-term allowed | Insulin regime short-term Acute illness | Insulin regime Gestational Diabetes

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0021641
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0557978
    UMLS CUI [2,2]
    C0443303
    UMLS CUI [2,3]
    C0683607
    UMLS CUI [3,1]
    C0557978
    UMLS CUI [3,2]
    C0443303
    UMLS CUI [3,3]
    C4061114
    UMLS CUI [4,1]
    C0557978
    UMLS CUI [4,2]
    C0085207
    hba1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
    Descrizione

    Hemoglobin A1c measurement

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. the definition for 'main meal' will be according to the investigator's discretion
    Descrizione

    Consumption Meal Main Quantity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0009830
    UMLS CUI [1,2]
    C1998602
    UMLS CUI [1,3]
    C1542147
    UMLS CUI [1,4]
    C1265611
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents)
    Descrizione

    Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Change of medication Affecting Body Weight | Change of medication Affecting Glucose metabolism | sibutramine | orlistat | Thyroid Hormones | CORTICOSTEROIDS FOR SYSTEMIC USE | Weight-Loss Agents

    Tipo di dati

    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 [3,1]
    C0580105
    UMLS CUI [3,2]
    C0392760
    UMLS CUI [3,3]
    C0005910
    UMLS CUI [4,1]
    C0580105
    UMLS CUI [4,2]
    C0392760
    UMLS CUI [4,3]
    C0596620
    UMLS CUI [5]
    C0074493
    UMLS CUI [6]
    C0076275
    UMLS CUI [7]
    C0040135
    UMLS CUI [8]
    C3653708
    UMLS CUI [9]
    C0376606
    impaired liver function, defined as alt (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
    Descrizione

    Liver Dysfunction | Alanine aminotransferase increased

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C0151905
    inadequately treated high blood pressure defined as class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm hg or diastolic equal to or above 100 mm hg) in accordance with the national high blood pressure education program, 7th joint national committee1 and esh/esc 2013 guidelines2
    Descrizione

    Hypertensive disease Treated Inadequate | Hypertensive disease Class | Systolic Pressure | Diastolic blood pressure

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020538
    UMLS CUI [1,2]
    C1522326
    UMLS CUI [1,3]
    C0205412
    UMLS CUI [2,1]
    C0020538
    UMLS CUI [2,2]
    C0456387
    UMLS CUI [3]
    C0871470
    UMLS CUI [4]
    C0428883
    within the past 180 days prior to randomisation, any of the following: myocardial infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack
    Descrizione

    Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0038454
    UMLS CUI [3,1]
    C0019993
    UMLS CUI [3,2]
    C0002965
    UMLS CUI [4,1]
    C0019993
    UMLS CUI [4,2]
    C0007787
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    Similar models

    Eligibility Diabetes NCT02453685

    1 moduli
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02453685
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    male or female, age at least 18 years at the time of signing informed consent
    boolean
    C0001779 (UMLS CUI [1])
    Non-Insulin-Dependent Diabetes Mellitus Disease length
    Item
    type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
    boolean
    C0011860 (UMLS CUI [1,1])
    C0872146 (UMLS CUI [1,2])
    Therapy Daily Dose Stable
    Item
    treatment with stable daily dose (for at least 90 days prior to screening) of: -
    boolean
    C0087111 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Metformin Dosage | Metformin Maximum Tolerated Dose | Sulfonylurea | Antidiabetics Oral To be stopped | Pills Insulin Releasing To be stopped | Dipeptidyl Peptidase-4 Inhibitor To be stopped | Sodium-Glucose Cotransporter 2 Inhibitor To be stopped | Colesevelam To be stopped | Bromocriptine To be stopped | Combination Product To be stopped
    Item
    metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, dpp4i (dipeptidyl peptidase-4 inhibitor), sglt2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
    boolean
    C0025598 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0025598 (UMLS CUI [2,1])
    C0752079 (UMLS CUI [2,2])
    C0038766 (UMLS CUI [3])
    C0935929 (UMLS CUI [4,1])
    C1527415 (UMLS CUI [4,2])
    C1272691 (UMLS CUI [4,3])
    C0994475 (UMLS CUI [5,1])
    C0021641 (UMLS CUI [5,2])
    C1283071 (UMLS CUI [5,3])
    C1272691 (UMLS CUI [5,4])
    C3537225 (UMLS CUI [6,1])
    C1272691 (UMLS CUI [6,2])
    C3542461 (UMLS CUI [7,1])
    C1272691 (UMLS CUI [7,2])
    C0541155 (UMLS CUI [8,1])
    C1272691 (UMLS CUI [8,2])
    C0006230 (UMLS CUI [9,1])
    C1272691 (UMLS CUI [9,2])
    C1880146 (UMLS CUI [10,1])
    C1272691 (UMLS CUI [10,2])
    Insulin Absent | Insulin regime short-term allowed | Insulin regime short-term Acute illness | Insulin regime Gestational Diabetes
    Item
    insulin-naïve. short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
    boolean
    C0021641 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0557978 (UMLS CUI [2,1])
    C0443303 (UMLS CUI [2,2])
    C0683607 (UMLS CUI [2,3])
    C0557978 (UMLS CUI [3,1])
    C0443303 (UMLS CUI [3,2])
    C4061114 (UMLS CUI [3,3])
    C0557978 (UMLS CUI [4,1])
    C0085207 (UMLS CUI [4,2])
    Hemoglobin A1c measurement
    Item
    hba1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
    boolean
    C0474680 (UMLS CUI [1])
    Consumption Meal Main Quantity
    Item
    willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. the definition for 'main meal' will be according to the investigator's discretion
    boolean
    C0009830 (UMLS CUI [1,1])
    C1998602 (UMLS CUI [1,2])
    C1542147 (UMLS CUI [1,3])
    C1265611 (UMLS CUI [1,4])
    Item Group
    C0680251 (UMLS CUI)
    Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Change of medication Affecting Body Weight | Change of medication Affecting Glucose metabolism | sibutramine | orlistat | Thyroid Hormones | CORTICOSTEROIDS FOR SYSTEMIC USE | Weight-Loss Agents
    Item
    anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents)
    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])
    C0580105 (UMLS CUI [3,1])
    C0392760 (UMLS CUI [3,2])
    C0005910 (UMLS CUI [3,3])
    C0580105 (UMLS CUI [4,1])
    C0392760 (UMLS CUI [4,2])
    C0596620 (UMLS CUI [4,3])
    C0074493 (UMLS CUI [5])
    C0076275 (UMLS CUI [6])
    C0040135 (UMLS CUI [7])
    C3653708 (UMLS CUI [8])
    C0376606 (UMLS CUI [9])
    Liver Dysfunction | Alanine aminotransferase increased
    Item
    impaired liver function, defined as alt (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
    boolean
    C0086565 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    Hypertensive disease Treated Inadequate | Hypertensive disease Class | Systolic Pressure | Diastolic blood pressure
    Item
    inadequately treated high blood pressure defined as class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm hg or diastolic equal to or above 100 mm hg) in accordance with the national high blood pressure education program, 7th joint national committee1 and esh/esc 2013 guidelines2
    boolean
    C0020538 (UMLS CUI [1,1])
    C1522326 (UMLS CUI [1,2])
    C0205412 (UMLS CUI [1,3])
    C0020538 (UMLS CUI [2,1])
    C0456387 (UMLS CUI [2,2])
    C0871470 (UMLS CUI [3])
    C0428883 (UMLS CUI [4])
    Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack
    Item
    within the past 180 days prior to randomisation, any of the following: myocardial infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack
    boolean
    C0027051 (UMLS CUI [1])
    C0038454 (UMLS CUI [2])
    C0019993 (UMLS CUI [3,1])
    C0002965 (UMLS CUI [3,2])
    C0019993 (UMLS CUI [4,1])
    C0007787 (UMLS CUI [4,2])
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