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ID

32518

Description

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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Versions (2)
  1. 10/1/18 10/1/18 -
  2. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

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License

Creative Commons BY-NC 3.0
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    Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

    English

    Day 11

    1 forms  
    1. StudyEvent: ODM
      1. Day 11
    12-Lead ECG
    Description

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Start Date of ECG
    Description

    12 lead ECG; Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Ventricular Rate
    Description

    12 lead ECG; Ventricular Rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C2189285
    bpm
    PR Interval
    Description

    12 lead ECG; PR Interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    QRS Duration
    Description

    12 lead ECG; QRS complex Duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    12 lead ECG; QT interval finding

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    QTc Interval
    Description

    12 lead ECG; QTc Interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    msec
    Result of the ECG
    Description

    12 lead ECG; result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0855331
    UMLS CUI [1,3]
    C1274040
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Description

    Date in time

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Blood Pressure (sitting) - Systolic
    Description

    Systolic Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure (sitting) - Diastolic
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate (sitting)
    Description

    Heart rate

    Data type

    text

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Electronically transferred laboratory data - Clinical Chemistry
    Description

    Electronically transferred laboratory data - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    Date Sample Taken
    Description

    Clinical Chemistry; Sampling; Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Description

    Clinical Chemistry; Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0040223
    Electronically transferred laboratory data - Haematology
    Description

    Electronically transferred laboratory data - Haematology

    Alias
    UMLS CUI-1
    C0474523
    Date Sample Taken
    Description

    Hematology finding; Sampling; Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Description

    Hematology finding; Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0040223
    Electronically transferred laboratory data - Urinalysis
    Description

    Electronically transferred laboratory data - Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Date Sample Taken
    Description

    Urinalysis; Sampling; Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Actual Time
    Description

    Urinalysis; Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
    Capillary Blood Glucose
    Description

    Capillary Blood Glucose

    Alias
    UMLS CUI-1
    C0457578
    Date
    Description

    Capillary Blood Glucose measurement; Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C0011008
    Planned relative time (e.g. prior to breakfast)
    Description

    Capillary Blood Glucose measurement; relative time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C0439564
    Time
    Description

    Capillary Blood Glucose measurement; Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C0040223
    Result
    Description

    Capillary Blood Glucose measurement; Result

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C1274040
    Unit
    Description

    Capillary Blood Glucose measurement; Unit of measure

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0457578
    UMLS CUI [1,2]
    C1519795
    Pharmacokinetics, Blood
    Description

    Pharmacokinetics, Blood

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Description

    Pharmacokinetic aspects; Blood; relative time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0439564
    Date Sample Taken
    Description

    Pharmacokinetic aspects; Blood; Sampling; Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Actual Time
    Description

    Pharmacokinetic aspects; Blood; Sampling; Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    Sample Number
    Description

    Pharmacokinetic aspects; Blood; Sample identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C1299222
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    Similar models

    Day 11

    1 forms
    1. StudyEvent: ODM
      1. Day 11
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    12 lead ECG; Start Date
    Item
    Start Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    12 lead ECG; Ventricular Rate
    Item
    Ventricular Rate
    integer
    C0430456 (UMLS CUI [1,1])
    C2189285 (UMLS CUI [1,2])
    12 lead ECG; PR Interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    12 lead ECG; QRS complex Duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    12 lead ECG; QT interval finding
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    12 lead ECG; QTc Interval
    Item
    QTc Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    Item
    Result of the ECG
    integer
    C0430456 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    12 lead ECG; result
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant  (2)
    CL Item
    Abnormal - Clinically significant (3)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date in time
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Systolic Pressure
    Item
    Blood Pressure (sitting) - Systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood Pressure (sitting) - Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate (sitting)
    text
    C0018810 (UMLS CUI [1])
    Item Group
    Electronically transferred laboratory data - Clinical Chemistry
    C0008000 (UMLS CUI-1)
    Clinical Chemistry; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Clinical Chemistry; Time
    Item
    Actual Time
    time
    C0008000 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Electronically transferred laboratory data - Haematology
    C0474523 (UMLS CUI-1)
    Hematology finding; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0474523 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Hematology finding; Time
    Item
    Actual Time
    time
    C0474523 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Electronically transferred laboratory data - Urinalysis
    C0042014 (UMLS CUI-1)
    Urinalysis; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Urinalysis; Time
    Item
    Actual Time
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Capillary Blood Glucose
    C0457578 (UMLS CUI-1)
    Capillary Blood Glucose measurement; Date in time
    Item
    Date
    date
    C0457578 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; relative time
    Item
    Planned relative time (e.g. prior to breakfast)
    text
    C0457578 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; Time
    Item
    Time
    time
    C0457578 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; Result
    Item
    Result
    float
    C0457578 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item
    Unit
    text
    C0457578 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Capillary Blood Glucose measurement; Unit of measure
    Code List
    Unit
    CL Item
    mmol/L (mmol/L)
    CL Item
    mg/dL (mg/dL)
    Item Group
    Pharmacokinetics, Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Pharmacokinetic aspects; Blood; relative time
    Item
    Planned Relative Time
    text
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    Pharmacokinetic aspects; Blood; Sampling; Date in time
    Item
    Date Sample Taken
    date
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Pharmacokinetic aspects; Blood; Sampling; Time
    Item
    Actual Time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetic aspects; Blood; Sample identification number
    Item
    Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [1,3])
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