0 Ratings

ID

17208

Description

Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00110370

Link

https://clinicaltrials.gov/show/NCT00110370

Keywords

  1. 8/31/16 8/31/16 -
Uploaded on

August 31, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Diabetes Mellitus, Type 2 NCT00110370

    Eligibility Diabetes Mellitus, Type 2 NCT00110370

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    must have type 2 diabetes.
    Description

    Diabetes Mellitus, Non-Insulin-Dependent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    must be 30-75 years of age at the time of visit 1.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
    Description

    Insulin Glargine | Oral hypoglycemic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0907402
    UMLS CUI [2]
    C0359086
    must be on at least 30 units of glargine per day at enrollment.
    Description

    Glargine U/day

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0907402
    UMLS CUI [1,2]
    C0456683
    have an a1c between 7.5% and 12.0% at visit 1.
    Description

    Glycosylated hemoglobin A

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
    Description

    Short-Acting Insulin Regular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0356365
    UMLS CUI [1,2]
    C0205272
    must not have more than one episode of severe hypoglycemia in the last 6 months.
    Description

    Hypoglycemia Severe Episode Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020615
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0332189
    UMLS CUI [1,4]
    C1265611
    must not have a body mass index (bmi) of greater than 45 (morbid obesity).
    Description

    Body mass index | Obesity, Morbid

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    UMLS CUI [2]
    C0028756
    must not have congestive heart failure that requires medications.
    Description

    Congestive heart failure Requirement Pharmaceutical Preparations

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0013227
    must not have had a kidney transplant or currently receiving dialysis
    Description

    Kidney Transplantation | Dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0022671
    UMLS CUI [2]
    C0011946

    Similar models

    Eligibility Diabetes Mellitus, Type 2 NCT00110370

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent
    Item
    must have type 2 diabetes.
    boolean
    C0011860 (UMLS CUI [1])
    Age
    Item
    must be 30-75 years of age at the time of visit 1.
    boolean
    C0001779 (UMLS CUI [1])
    Insulin Glargine | Oral hypoglycemic
    Item
    must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
    boolean
    C0907402 (UMLS CUI [1])
    C0359086 (UMLS CUI [2])
    Glargine U/day
    Item
    must be on at least 30 units of glargine per day at enrollment.
    boolean
    C0907402 (UMLS CUI [1,1])
    C0456683 (UMLS CUI [1,2])
    Glycosylated hemoglobin A
    Item
    have an a1c between 7.5% and 12.0% at visit 1.
    boolean
    C0019018 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Short-Acting Insulin Regular
    Item
    must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
    boolean
    C0356365 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
    Hypoglycemia Severe Episode Quantity
    Item
    must not have more than one episode of severe hypoglycemia in the last 6 months.
    boolean
    C0020615 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0332189 (UMLS CUI [1,3])
    C1265611 (UMLS CUI [1,4])
    Body mass index | Obesity, Morbid
    Item
    must not have a body mass index (bmi) of greater than 45 (morbid obesity).
    boolean
    C1305855 (UMLS CUI [1])
    C0028756 (UMLS CUI [2])
    Congestive heart failure Requirement Pharmaceutical Preparations
    Item
    must not have congestive heart failure that requires medications.
    boolean
    C0018802 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Kidney Transplantation | Dialysis
    Item
    must not have had a kidney transplant or currently receiving dialysis
    boolean
    C0022671 (UMLS CUI [1])
    C0011946 (UMLS CUI [2])

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