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ID

35741

Description

Empagliflozin as Adjunctive to inSulin thErapy in Type 1 Diabetes Over 52 Weeks (EASE-2); ODM derived from: https://clinicaltrials.gov/show/NCT02414958

Link

https://clinicaltrials.gov/show/NCT02414958

Keywords

Versions (1)
  1. 3/19/19 3/19/19 -
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See clinicaltrials.gov

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March 19, 2019

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Creative Commons BY 4.0
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    Eligibility Diabetes Mellitus, Type 1 NCT02414958

    English

    Eligibility Diabetes Mellitus, Type 1 NCT02414958

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    male or female patient receiving insulin for the treatment of documented diagnosis of t1dm for at least 1 year at the time of visit 1
    Description

    Insulin regime Insulin-Dependent Diabetes Mellitus Disease length

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0557978
    UMLS CUI [1,2]
    C0011854
    UMLS CUI [1,3]
    C0872146
    fasting c-peptide value of < 0.7 ng/ml (0.23 nmol/l) at visit 2 measured by the central laboratory
    Description

    Fasting C-peptide level

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2208720
    use of, and be willing, based on the investigator's judgement, to continue throughout the duration of the trial, either:
    Description

    Use of

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1524063
    mdi of insulin consisting of at least one basal insulin injection and at least three daily bolus injections or
    Description

    Daily Dose Multiple Injection of insulin | Basal insulin Injection Quantity | Bolus infusion Quantity Daily

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0439064
    UMLS CUI [1,3]
    C0199782
    UMLS CUI [2,1]
    C0650607
    UMLS CUI [2,2]
    C1828121
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [3,1]
    C1511237
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C0332173
    csii of any insulin type, with at least 5 months experience of using csii prior to visit 1
    Description

    Continuous subcutaneous infusion of insulin Type Any

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0393124
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1552551
    hba1c >/= 7.5% and </= 10.0% at visit 5 measured by the central laboratory
    Description

    Hemoglobin A1c measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    age >/= 18 years at visit 1
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    additional inclusion criteria may apply
    Description

    Inclusion criteria Additional

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C1524062
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    history of t2dm, maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis
    Description

    Diabetes Mellitus, Non-Insulin-Dependent | Maturity onset diabetes mellitus in young | Pancreatic surgery | Pancreatitis, Chronic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    UMLS CUI [2]
    C0342276
    UMLS CUI [3]
    C2033062
    UMLS CUI [4]
    C0149521
    pancreas, pancreatic islet cells or renal transplant recipient
    Description

    Pancreas transplant recipient | Islets of Langerhans Transplant Recipients | Renal transplant recipient

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2033004
    UMLS CUI [2,1]
    C0022131
    UMLS CUI [2,2]
    C0376387
    UMLS CUI [3]
    C2063399
    t1dm treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glp-1 analogues, sglt-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to visit 1
    Description

    Diabetes Mellitus, Insulin-Dependent | Hypoglycemic Agents | Metformin | alpha-Glucosidase Inhibitors | GLP-1 Analogue | SGLT2 Inhibitor | Pramlintide | Insulin By inhalation | Premixed insulin | Exception Basal insulin Subcutaneous | Exception Insulin Bolus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    UMLS CUI [2]
    C0020616
    UMLS CUI [3]
    C0025598
    UMLS CUI [4]
    C1299007
    UMLS CUI [5]
    C3273809
    UMLS CUI [6]
    C3273807
    UMLS CUI [7]
    C0537551
    UMLS CUI [8,1]
    C0021641
    UMLS CUI [8,2]
    C0001559
    UMLS CUI [9]
    C2069057
    UMLS CUI [10,1]
    C1705847
    UMLS CUI [10,2]
    C0650607
    UMLS CUI [10,3]
    C1522438
    UMLS CUI [11,1]
    C1705847
    UMLS CUI [11,2]
    C0021641
    UMLS CUI [11,3]
    C1705509
    occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to visit 1
    Description

    Hypoglycemia Severe Involving Coma | Hypoglycemia Severe Involving Seizure | Hospitalization Required | Patient need for Emergency treatment Hypoglycemia

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020615
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C1314939
    UMLS CUI [1,4]
    C0009421
    UMLS CUI [2,1]
    C0020615
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C1314939
    UMLS CUI [2,4]
    C0036572
    UMLS CUI [3]
    C1708385
    UMLS CUI [4,1]
    C0686904
    UMLS CUI [4,2]
    C0013969
    UMLS CUI [4,3]
    C0020615
    occurence of severe dka (i.e a ph of <7.0 or prolonged intensive care unit admission exceeding two days) requiring hospitalisation within 3 months prior to visit 1
    Description

    Diabetic Ketoacidosis Severe | Finding of pH | Admission to intensive care unit Prolonged | Hospitalization Required

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011880
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C1304686
    UMLS CUI [3,1]
    C0583239
    UMLS CUI [3,2]
    C0439590
    UMLS CUI [4]
    C1708385
    additional exclusion criteria may apply
    Description

    Exclusion Criteria Additional

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1524062
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    Similar models

    Eligibility Diabetes Mellitus, Type 1 NCT02414958

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Insulin regime Insulin-Dependent Diabetes Mellitus Disease length
    Item
    male or female patient receiving insulin for the treatment of documented diagnosis of t1dm for at least 1 year at the time of visit 1
    boolean
    C0557978 (UMLS CUI [1,1])
    C0011854 (UMLS CUI [1,2])
    C0872146 (UMLS CUI [1,3])
    Fasting C-peptide level
    Item
    fasting c-peptide value of < 0.7 ng/ml (0.23 nmol/l) at visit 2 measured by the central laboratory
    boolean
    C2208720 (UMLS CUI [1])
    Use of
    Item
    use of, and be willing, based on the investigator's judgement, to continue throughout the duration of the trial, either:
    boolean
    C1524063 (UMLS CUI [1])
    Daily Dose Multiple Injection of insulin | Basal insulin Injection Quantity | Bolus infusion Quantity Daily
    Item
    mdi of insulin consisting of at least one basal insulin injection and at least three daily bolus injections or
    boolean
    C2348070 (UMLS CUI [1,1])
    C0439064 (UMLS CUI [1,2])
    C0199782 (UMLS CUI [1,3])
    C0650607 (UMLS CUI [2,1])
    C1828121 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C1511237 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0332173 (UMLS CUI [3,3])
    Continuous subcutaneous infusion of insulin Type Any
    Item
    csii of any insulin type, with at least 5 months experience of using csii prior to visit 1
    boolean
    C0393124 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1552551 (UMLS CUI [1,3])
    Hemoglobin A1c measurement
    Item
    hba1c >/= 7.5% and </= 10.0% at visit 5 measured by the central laboratory
    boolean
    C0474680 (UMLS CUI [1])
    Age
    Item
    age >/= 18 years at visit 1
    boolean
    C0001779 (UMLS CUI [1])
    Inclusion criteria Additional
    Item
    additional inclusion criteria may apply
    boolean
    C1512693 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent | Maturity onset diabetes mellitus in young | Pancreatic surgery | Pancreatitis, Chronic
    Item
    history of t2dm, maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis
    boolean
    C0011860 (UMLS CUI [1])
    C0342276 (UMLS CUI [2])
    C2033062 (UMLS CUI [3])
    C0149521 (UMLS CUI [4])
    Pancreas transplant recipient | Islets of Langerhans Transplant Recipients | Renal transplant recipient
    Item
    pancreas, pancreatic islet cells or renal transplant recipient
    boolean
    C2033004 (UMLS CUI [1])
    C0022131 (UMLS CUI [2,1])
    C0376387 (UMLS CUI [2,2])
    C2063399 (UMLS CUI [3])
    Diabetes Mellitus, Insulin-Dependent | Hypoglycemic Agents | Metformin | alpha-Glucosidase Inhibitors | GLP-1 Analogue | SGLT2 Inhibitor | Pramlintide | Insulin By inhalation | Premixed insulin | Exception Basal insulin Subcutaneous | Exception Insulin Bolus
    Item
    t1dm treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glp-1 analogues, sglt-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to visit 1
    boolean
    C0011854 (UMLS CUI [1])
    C0020616 (UMLS CUI [2])
    C0025598 (UMLS CUI [3])
    C1299007 (UMLS CUI [4])
    C3273809 (UMLS CUI [5])
    C3273807 (UMLS CUI [6])
    C0537551 (UMLS CUI [7])
    C0021641 (UMLS CUI [8,1])
    C0001559 (UMLS CUI [8,2])
    C2069057 (UMLS CUI [9])
    C1705847 (UMLS CUI [10,1])
    C0650607 (UMLS CUI [10,2])
    C1522438 (UMLS CUI [10,3])
    C1705847 (UMLS CUI [11,1])
    C0021641 (UMLS CUI [11,2])
    C1705509 (UMLS CUI [11,3])
    Hypoglycemia Severe Involving Coma | Hypoglycemia Severe Involving Seizure | Hospitalization Required | Patient need for Emergency treatment Hypoglycemia
    Item
    occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to visit 1
    boolean
    C0020615 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1314939 (UMLS CUI [1,3])
    C0009421 (UMLS CUI [1,4])
    C0020615 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C1314939 (UMLS CUI [2,3])
    C0036572 (UMLS CUI [2,4])
    C1708385 (UMLS CUI [3])
    C0686904 (UMLS CUI [4,1])
    C0013969 (UMLS CUI [4,2])
    C0020615 (UMLS CUI [4,3])
    Diabetic Ketoacidosis Severe | Finding of pH | Admission to intensive care unit Prolonged | Hospitalization Required
    Item
    occurence of severe dka (i.e a ph of <7.0 or prolonged intensive care unit admission exceeding two days) requiring hospitalisation within 3 months prior to visit 1
    boolean
    C0011880 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1304686 (UMLS CUI [2])
    C0583239 (UMLS CUI [3,1])
    C0439590 (UMLS CUI [3,2])
    C1708385 (UMLS CUI [4])
    Exclusion Criteria Additional
    Item
    additional exclusion criteria may apply
    boolean
    C0680251 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
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