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ID

41629

Description

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Keywords

Versions (2)
  1. 11/16/20 11/16/20 -
  2. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

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License

Creative Commons BY 4.0
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    Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

    English

    Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site
    Description

    Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject
    Description

    Subject

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Status
    Description

    Status

    Data type

    text

    Alias
    UMLS CUI [1]
    C0449438
    Doc#
    Description

    Doc#

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1301746
    Is Page Blank?
    Description

    Is Page Blank?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C0750479
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Study Completion
    Description

    Study Completion

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C0444930
    Date of final contact
    Description

    Date of final contact

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839
    Date of last dose
    Description

    Date of last dose

    Data type

    date

    Alias
    UMLS CUI [1]
    C1762893
    Did subject complete the study?
    Description

    Did subject complete the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    Date of discontinuation
    Description

    Date of discontinuation

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0457454
    UMLS CUI [1,2]
    C0011008
    If subject did not complete the study, mark ONE reason
    Description

    If subject did not complete the study, mark ONE reason

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3827242
    UMLS CUI [1,2]
    C0566251
    Specify AE No (Liver chemistry stopping criteria)
    Description

    Specify AE No (Liver chemistry stopping criteria)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2,1]
    C0023884
    UMLS CUI [2,2]
    C0008000
    UMLS CUI [3,1]
    C2746065
    UMLS CUI [3,2]
    C0243161
    Specify AE No (Adverse event)
    Description

    Specify AE No (Adverse event)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0237753
    Specify AE No (Severe or repeated occurences of hypoglycaemia)
    Description

    Specify AE No (Severe or repeated occurences of hypoglycaemia)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C0342316
    Specify AE No (Occurence of Pancreatitis)
    Description

    Specify AE No (Occurence of Pancreatitis)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C0030305
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Vital Signs (Unscheduled)
    Description

    Vital Signs (Unscheduled)

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C3854240
    Vital Signs - Repeat or Unscheduled?
    Description

    Vital Signs - Repeat or Unscheduled?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2]
    C0205341
    UMLS CUI [3]
    C3854240
    Vital Signs - If Repeat, please specify original period/day
    Description

    Vital Signs - If Repeat, please specify original period/day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2]
    C0205341
    UMLS CUI [3]
    C2347804
    UMLS CUI [4]
    C0439228
    Vital Signs - Date
    Description

    Vital Signs - Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Vital Signs - Time
    Description

    Vital Signs - Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Respirations
    Description

    Respirations

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0035203
    breaths/min
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Vital Signs - Body Position
    Description

    Vital Signs - Body Position

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1262869
    Vital Signs - Comment
    Description

    Vital Signs - Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2]
    C0947611
    Physical Examination (Unscheduled Visit)
    Description

    Physical Examination (Unscheduled Visit)

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C3854240
    Date of Physical Exam
    Description

    Date of Physical Exam

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    Assessment
    Description

    Assessment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2911685
    Electrocardiogram (Unscheduled)
    Description

    Electrocardiogram (Unscheduled)

    Alias
    UMLS CUI-1
    C0013798
    UMLS CUI-2
    C3854240
    Electrocardiogram - Repeat or Unscheduled?
    Description

    Electrocardiogram - Repeat or Unscheduled?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013798
    UMLS CUI [2]
    C0205341
    UMLS CUI [3]
    C3854240
    Electrocardiogram - If Repeat, please specify original Period/Day
    Description

    Electrocardiogram - If Repeat, please specify original Period/Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013798
    UMLS CUI [2]
    C0205341
    UMLS CUI [3]
    C2347804
    UMLS CUI [4]
    C0439228
    Electrocardiogram - Date
    Description

    Electrocardiogram - Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826640
    Electrocardiogram - Time
    Description

    Electrocardiogram - Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0040223
    Electrocardiogram - Heart Rate
    Description

    Electrocardiogram - Heart Rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0013798
    UMLS CUI [2]
    C0018810
    bpm
    Electrocardiogram - PR Interval
    Description

    Electrocardiogram - PR Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    Electrocardiogram - QRS Duration
    Description

    Electrocardiogram - QRS Duration

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1]
    C0013798
    UMLS CUI [2]
    C0429025
    ms
    Electrocardiogram - QT Interval
    Description

    Electrocardiogram - QT Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C1287082
    ms
    Electrocardiogram - Q-TcB Interval
    Description

    Electrocardiogram - Q-TcB Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1,1]
    C0429087
    UMLS CUI [1,2]
    C1882512
    ms
    Electrocardiogram - Q-TcF Interval
    Description

    Electrocardiogram - Q-TcF Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1,1]
    C0429087
    UMLS CUI [1,2]
    C1882513
    ms
    Electrocardiogram - RR Interval
    Description

    Electrocardiogram - RR Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0489636
    ms
    Electrocardiogram - Normal Sinus Rhythm?
    Description

    Electrocardiogram - Normal Sinus Rhythm?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960147
    Overall Interpretation of ECG
    Description

    Overall Interpretation of ECG

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0459471
    Electrocardiogram - If abnormal, please specify
    Description

    Electrocardiogram - If abnormal, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C2348235
    Central Laboratory Blood (Unscheduled)
    Description

    Central Laboratory Blood (Unscheduled)

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0005767
    Central Laboratory Blood
    Description

    Central Laboratory Blood

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0005767
    Central Laboratory Blood - Repeat or Unscheduled?
    Description

    Central Laboratory Blood - Repeat or Unscheduled?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0205341
    UMLS CUI [2]
    C0005767
    UMLS CUI [3]
    C3854240
    Central Laboratory Blood - If Repeat, please specify original period/day:
    Description

    Central Laboratory Blood - If Repeat, please specify original period/day:

    Data type

    text

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0005767
    UMLS CUI [3]
    C0205341
    UMLS CUI [4]
    C2347804
    UMLS CUI [5]
    C0439228
    UMLS CUI [6]
    C2348235
    Central Laboratory Blood - Sample Date
    Description

    Central Laboratory Blood - Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0005767
    UMLS CUI [3]
    C1302413
    Central Laboratory Blood - Sample Time
    Description

    Central Laboratory Blood - Sample Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0005767
    UMLS CUI [3,1]
    C0040223
    UMLS CUI [3,2]
    C0200345
    Central Laboratory Blood - Comment
    Description

    Central Laboratory Blood - Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0005767
    UMLS CUI [3]
    C0947611
    Central Laboratory Urine (Unscheduled)
    Description

    Central Laboratory Urine (Unscheduled)

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0042036
    Central Laboratory Urine
    Description

    Central Laboratory Urine

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0042036
    Central Laboratory Urine - Repeat or Unscheduled?
    Description

    Central Laboratory Urine - Repeat or Unscheduled?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205341
    UMLS CUI [2]
    C0042036
    UMLS CUI [3]
    C3854240
    Central Laboratory Urine - If Repeat, please specify original period/day:
    Description

    Central Laboratory Urine - If Repeat, please specify original period/day:

    Data type

    text

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0042036
    UMLS CUI [3]
    C0205341
    UMLS CUI [4]
    C2347804
    UMLS CUI [5]
    C0439228
    UMLS CUI [6]
    C2348235
    Central Laboratory Urine - Sample Date
    Description

    Central Laboratory Urine - Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0042036
    UMLS CUI [3]
    C1302413
    Central Laboratory Urine - Sample Time
    Description

    Central Laboratory Urine - Sample Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0042036
    UMLS CUI [3,1]
    C0040223
    UMLS CUI [3,2]
    C0200345
    Central Laboratory Urine - Comment
    Description

    Central Laboratory Urine - Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C1880016
    UMLS CUI [2]
    C0042036
    UMLS CUI [3]
    C0947611
    Hypoglycaemia
    Description

    Hypoglycaemia

    Alias
    UMLS CUI-1
    C0020615
    Has the subject experienced any protocol defined hypoglycaemic events?
    Description

    Has the subject experienced any protocol defined hypoglycaemic events?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0745153
    UMLS CUI [2]
    C2348563
    AE/SAE Reference Event Number
    Description

    AE/SAE Reference Event Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0237753
    Start date of Event
    Description

    Start date of Event

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888
    Start time of Event
    Description

    Start time of Event

    Data type

    time

    Alias
    UMLS CUI [1]
    C2697889
    End date of Event
    Description

    End date of Event

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886
    End time of Event
    Description

    End time of Event

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826658
    Blood Glucose Test Result at Time of Event (mg/dL)
    Description

    Blood Glucose Test Result at Time of Event (mg/dL)

    Data type

    integer

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1]
    C0457578
    UMLS CUI [2]
    C0040223
    UMLS CUI [3]
    C2697889
    mg/dL
    Blood Glucose Test Result at Time of Event (mmol/L)
    Description

    Blood Glucose Test Result at Time of Event (mmol/L)

    Data type

    integer

    Measurement units
    • mmol/L
    Alias
    UMLS CUI [1]
    C0457578
    UMLS CUI [2]
    C0040223
    UMLS CUI [3]
    C2697889
    mmol/L
    Frequency
    Description

    Frequency

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0439603
    Severity of hypoglycaemic event: (per ADA working group guidelines)
    Description

    Severity of hypoglycaemic event: (per ADA working group guidelines)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1710066
    UMLS CUI [2]
    C0745153
    If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
    Description

    If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0205082
    Required days of hospitalization
    Description

    Please follow serious adverse event instructions.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019993
    UMLS CUI [2]
    C0439228
    Intervention (enter the most severe, enter details on concomitant medication page if applicable)
    Description

    Intervention (enter the most severe, enter details on concomitant medication page if applicable)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0184661
    Action Taken with Background or Anti-Hyperglycemic Medication?
    Description

    Action Taken with Background or Anti-Hyperglycemic Medication?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826626
    Injection Site Reaction
    Description

    Injection Site Reaction

    Alias
    UMLS CUI-1
    C0151735
    AE/SAE Number
    Description

    AE/SAE Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C0237753
    Date of injection
    Description

    Date of injection

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0021485
    Date of Reaction
    Description

    Date of Reaction

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0443286
    UMLS CUI [1,2]
    C0011008
    Size of skin reaction 1. diameter
    Description

    (maximum)

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0221743
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [2]
    C1301886
    mm
    Size of skin reaction 2. diameter
    Description

    (maximum)

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C0221743
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [2]
    C1301886
    mm
    Location of injection
    Description

    Location of injection

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2700396
    Specify other location of injection
    Description

    Specify other location of injection

    Data type

    text

    Alias
    UMLS CUI [1]
    C2700396
    UMLS CUI [2]
    C0205394
    UMLS CUI [3]
    C2348235
    Was this local reaction within 24 hrs of dose?
    Description

    Was this local reaction within 24 hrs of dose?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0853813
    UMLS CUI [2]
    C0178602
    Check all that apply regarding local reaction symptoms:
    Description

    Check all that apply regarding local reaction symptoms:

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0853813
    Specify other symptoms
    Description

    Specify other symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C1457887
    UMLS CUI [2]
    C0205394
    UMLS CUI [3]
    C2348235
    Was treatment given for this local reaction?
    Description

    If Yes, please record all treatments on the Concomitant Medications/Non-drug Therapies eCRF

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0853813
    UMLS CUI [2]
    C0087111
    Serum sample obtained?
    Description

    Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1-mL serum samples obtained for immunogenicity testing.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0229671
    UMLS CUI [2]
    C0200345
    Provide date sample obtained
    Description

    Provide date sample obtained

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
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    Similar models

    Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Subject
    Item
    Subject
    text
    C2348585 (UMLS CUI [1])
    Status
    Item
    Status
    text
    C0449438 (UMLS CUI [1])
    Doc#
    Item
    Doc#
    integer
    C1301746 (UMLS CUI [1])
    Is Page Blank?
    Item
    Is Page Blank?
    boolean
    C1704732 (UMLS CUI [1,1])
    C0750479 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Study Completion
    C0008976 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Date of final contact
    Item
    Date of final contact
    date
    C0805839 (UMLS CUI [1])
    Date of last dose
    Item
    Date of last dose
    date
    C1762893 (UMLS CUI [1])
    Did subject complete the study?
    Item
    Did subject complete the study?
    boolean
    C2348577 (UMLS CUI [1])
    Date of discontinuation
    Item
    Date of discontinuation
    date
    C0457454 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    If subject did not complete the study, mark ONE reason
    integer
    C3827242 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    If subject did not complete the study, mark ONE reason
    Code List
    If subject did not complete the study, mark ONE reason
    CL Item
    Liver chemistry stopping criteria (specify AE No) (1)
    CL Item
    Adverse event (specify AE No) (2)
    CL Item
    Severe or repeated occurences of hypoglycaemia (specify AE No) (3)
    CL Item
    Occurence of Pancreatitits (AE No) (4)
    CL Item
    Consent withdrawn (5)
    CL Item
    Lost to Follow-Up (6)
    CL Item
    Protocol violation (7)
    CL Item
    Noncompliance with study visit schedule (8)
    CL Item
    Termination of study by sponsor (9)
    CL Item
    Pregnancy (10)
    CL Item
    Other (specify in comments) (11)
    Specify AE No (Liver chemistry stopping criteria)
    Item
    Specify AE No (Liver chemistry stopping criteria)
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0023884 (UMLS CUI [2,1])
    C0008000 (UMLS CUI [2,2])
    C2746065 (UMLS CUI [3,1])
    C0243161 (UMLS CUI [3,2])
    Specify AE No (Adverse event)
    Item
    Specify AE No (Adverse event)
    integer
    C0877248 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Specify AE No (Severe or repeated occurences of hypoglycaemia)
    Item
    Specify AE No (Severe or repeated occurences of hypoglycaemia)
    integer
    C0877248 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0342316 (UMLS CUI [2])
    Specify AE No (Occurence of Pancreatitis)
    Item
    Specify AE No (Occurence of Pancreatitis)
    integer
    C0877248 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0030305 (UMLS CUI [2])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Vital Signs (Unscheduled)
    C0518766 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Item
    Vital Signs - Repeat or Unscheduled?
    integer
    C0518766 (UMLS CUI [1])
    C0205341 (UMLS CUI [2])
    C3854240 (UMLS CUI [3])
    Repeat or Unscheduled?
    Code List
    Vital Signs - Repeat or Unscheduled?
    CL Item
    Repeat (1)
    CL Item
    Unscheduled (2)
    Vital Signs - If Repeat, please specify original period/day
    Item
    Vital Signs - If Repeat, please specify original period/day
    text
    C0518766 (UMLS CUI [1])
    C0205341 (UMLS CUI [2])
    C2347804 (UMLS CUI [3])
    C0439228 (UMLS CUI [4])
    Vital Signs - Date
    Item
    Vital Signs - Date
    date
    C2826644 (UMLS CUI [1])
    Vital Signs - Time
    Item
    Vital Signs - Time
    time
    C2826762 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Respirations
    Item
    Respirations
    integer
    C0035203 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Vital Signs - Body Position
    integer
    C0518766 (UMLS CUI [1,1])
    C1262869 (UMLS CUI [1,2])
    Body Position
    Code List
    Vital Signs - Body Position
    CL Item
    Sitting (1)
    CL Item
    Standing (2)
    CL Item
    Supine (3)
    Vital Signs - Comment
    Item
    Vital Signs - Comment
    text
    C0518766 (UMLS CUI [1])
    C0947611 (UMLS CUI [2])
    Item Group
    Physical Examination (Unscheduled Visit)
    C0031809 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Date of Physical Exam
    Item
    Date of Physical Exam
    date
    C2826643 (UMLS CUI [1])
    Item
    Assessment
    integer
    C2911685 (UMLS CUI [1])
    Assessment
    Code List
    Assessment
    CL Item
    Skin including Injection Site (1)
    CL Item
    Head, Eyes, Ears, Nose, Throat (2)
    CL Item
    Thyroid (3)
    CL Item
    Central Nervous System (4)
    CL Item
    Respiratory System (5)
    CL Item
    Cardiovascular System (6)
    CL Item
    Abdomen (Liver and Spleen) (7)
    CL Item
    Lymph Nodes (8)
    CL Item
    Extremities (9)
    CL Item
    Other (10)
    Item Group
    Electrocardiogram (Unscheduled)
    C0013798 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Item
    Electrocardiogram - Repeat or Unscheduled?
    integer
    C0013798 (UMLS CUI [1])
    C0205341 (UMLS CUI [2])
    C3854240 (UMLS CUI [3])
    Electrocardiogram - Repeat or Unscheduled?
    Code List
    Electrocardiogram - Repeat or Unscheduled?
    CL Item
    Repeat (1)
    CL Item
    Unscheduled (2)
    Electrocardiogram - If Repeat, please specify original Period/Day
    Item
    Electrocardiogram - If Repeat, please specify original Period/Day
    text
    C0013798 (UMLS CUI [1])
    C0205341 (UMLS CUI [2])
    C2347804 (UMLS CUI [3])
    C0439228 (UMLS CUI [4])
    Electrocardiogram - Date
    Item
    Electrocardiogram - Date
    date
    C2826640 (UMLS CUI [1])
    Electrocardiogram - Time
    Item
    Electrocardiogram - Time
    time
    C0013798 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Electrocardiogram - Heart Rate
    Item
    Electrocardiogram - Heart Rate
    integer
    C0013798 (UMLS CUI [1])
    C0018810 (UMLS CUI [2])
    Electrocardiogram - PR Interval
    Item
    Electrocardiogram - PR Interval
    integer
    C0429087 (UMLS CUI [1])
    Electrocardiogram - QRS Duration
    Item
    Electrocardiogram - QRS Duration
    integer
    C0013798 (UMLS CUI [1])
    C0429025 (UMLS CUI [2])
    Electrocardiogram - QT Interval
    Item
    Electrocardiogram - QT Interval
    integer
    C0013798 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    Electrocardiogram - Q-TcB Interval
    Item
    Electrocardiogram - Q-TcB Interval
    integer
    C0429087 (UMLS CUI [1,1])
    C1882512 (UMLS CUI [1,2])
    Electrocardiogram - Q-TcF Interval
    Item
    Electrocardiogram - Q-TcF Interval
    integer
    C0429087 (UMLS CUI [1,1])
    C1882513 (UMLS CUI [1,2])
    Electrocardiogram - RR Interval
    Item
    Electrocardiogram - RR Interval
    integer
    C0013798 (UMLS CUI [1,1])
    C0489636 (UMLS CUI [1,2])
    Electrocardiogram - Normal Sinus Rhythm?
    Item
    Electrocardiogram - Normal Sinus Rhythm?
    boolean
    C1960147 (UMLS CUI [1])
    Item
    Overall Interpretation of ECG
    integer
    C1623258 (UMLS CUI [1,1])
    C0459471 (UMLS CUI [1,2])
    Overall Interpretation of ECG
    Code List
    Overall Interpretation of ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal; Not Clinically Significant (2)
    CL Item
    Abnormal; Clinically Significant (3)
    Electrocardiogram - If abnormal, please specify
    Item
    Electrocardiogram - If abnormal, please specify
    text
    C0522055 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Central Laboratory Blood (Unscheduled)
    C1880016 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0005767 (UMLS CUI-3)
    Item
    Central Laboratory Blood
    integer
    C1880016 (UMLS CUI [1])
    C0005767 (UMLS CUI [2])
    Central Laboratory
    Code List
    Central Laboratory Blood
    CL Item
    Haematology (1)
    CL Item
    Chemistry (2)
    CL Item
    Serology (3)
    CL Item
    Serum HCG (4)
    CL Item
    SP Chem (5)
    Item
    Central Laboratory Blood - Repeat or Unscheduled?
    integer
    C0205341 (UMLS CUI [1])
    C0005767 (UMLS CUI [2])
    C3854240 (UMLS CUI [3])
    Repeat or Unscheduled?
    Code List
    Central Laboratory Blood - Repeat or Unscheduled?
    CL Item
    Repeat (1)
    CL Item
    Unscheduled (2)
    Central Laboratory Blood - If Repeat, please specify original period/day:
    Item
    Central Laboratory Blood - If Repeat, please specify original period/day:
    text
    C1880016 (UMLS CUI [1])
    C0005767 (UMLS CUI [2])
    C0205341 (UMLS CUI [3])
    C2347804 (UMLS CUI [4])
    C0439228 (UMLS CUI [5])
    C2348235 (UMLS CUI [6])
    Central Laboratory Blood - Sample Date
    Item
    Central Laboratory Blood - Sample Date
    date
    C1880016 (UMLS CUI [1])
    C0005767 (UMLS CUI [2])
    C1302413 (UMLS CUI [3])
    Central Laboratory Blood - Sample Time
    Item
    Central Laboratory Blood - Sample Time
    time
    C1880016 (UMLS CUI [1])
    C0005767 (UMLS CUI [2])
    C0040223 (UMLS CUI [3,1])
    C0200345 (UMLS CUI [3,2])
    Central Laboratory Blood - Comment
    Item
    Central Laboratory Blood - Comment
    text
    C1880016 (UMLS CUI [1])
    C0005767 (UMLS CUI [2])
    C0947611 (UMLS CUI [3])
    Item Group
    Central Laboratory Urine (Unscheduled)
    C1880016 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0042036 (UMLS CUI-3)
    Item
    Central Laboratory Urine
    integer
    C1880016 (UMLS CUI [1,1])
    C0042036 (UMLS CUI [1,2])
    Central Laboratory Urine
    Code List
    Central Laboratory Urine
    CL Item
    UA (1)
    CL Item
    UDS (2)
    CL Item
    Urine HCG (3)
    CL Item
    Urine Chem (4)
    Central Laboratory Urine - Repeat or Unscheduled?
    Item
    Central Laboratory Urine - Repeat or Unscheduled?
    text
    C0205341 (UMLS CUI [1])
    C0042036 (UMLS CUI [2])
    C3854240 (UMLS CUI [3])
    Central Laboratory Urine - If Repeat, please specify original period/day:
    Item
    Central Laboratory Urine - If Repeat, please specify original period/day:
    text
    C1880016 (UMLS CUI [1])
    C0042036 (UMLS CUI [2])
    C0205341 (UMLS CUI [3])
    C2347804 (UMLS CUI [4])
    C0439228 (UMLS CUI [5])
    C2348235 (UMLS CUI [6])
    Central Laboratory Urine - Sample Date
    Item
    Central Laboratory Urine - Sample Date
    date
    C1880016 (UMLS CUI [1])
    C0042036 (UMLS CUI [2])
    C1302413 (UMLS CUI [3])
    Central Laboratory Urine - Sample Time
    Item
    Central Laboratory Urine - Sample Time
    time
    C1880016 (UMLS CUI [1])
    C0042036 (UMLS CUI [2])
    C0040223 (UMLS CUI [3,1])
    C0200345 (UMLS CUI [3,2])
    Central Laboratory Urine - Comment
    Item
    Central Laboratory Urine - Comment
    text
    C1880016 (UMLS CUI [1])
    C0042036 (UMLS CUI [2])
    C0947611 (UMLS CUI [3])
    Item Group
    Hypoglycaemia
    C0020615 (UMLS CUI-1)
    Has the subject experienced any protocol defined hypoglycaemic events?
    Item
    Has the subject experienced any protocol defined hypoglycaemic events?
    boolean
    C0745153 (UMLS CUI [1])
    C2348563 (UMLS CUI [2])
    AE/SAE Reference Event Number
    Item
    AE/SAE Reference Event Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [2,1])
    C0237753 (UMLS CUI [2,2])
    Start date of Event
    Item
    Start date of Event
    date
    C2697888 (UMLS CUI [1])
    Start time of Event
    Item
    Start time of Event
    time
    C2697889 (UMLS CUI [1])
    End date of Event
    Item
    End date of Event
    date
    C2697886 (UMLS CUI [1])
    End time of Event
    Item
    End time of Event
    time
    C2826658 (UMLS CUI [1])
    Blood Glucose Test Result at Time of Event (mg/dL)
    Item
    Blood Glucose Test Result at Time of Event (mg/dL)
    integer
    C0457578 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    C2697889 (UMLS CUI [3])
    Blood Glucose Test Result at Time of Event (mmol/L)
    Item
    Blood Glucose Test Result at Time of Event (mmol/L)
    integer
    C0457578 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    C2697889 (UMLS CUI [3])
    Item
    Frequency
    integer
    C0439603 (UMLS CUI [1])
    Frequency
    Code List
    Frequency
    CL Item
    Single episode (1)
    CL Item
    Intermittent (2)
    Item
    Severity of hypoglycaemic event: (per ADA working group guidelines)
    integer
    C1710066 (UMLS CUI [1])
    C0745153 (UMLS CUI [2])
    Severity of hypoglycaemic event: (per ADA working group guidelines)
    Code List
    Severity of hypoglycaemic event: (per ADA working group guidelines)
    CL Item
    Severe (1)
    CL Item
    Documented Symptomatic (2)
    CL Item
    Asymptomatic (3)
    CL Item
    Probable Symptomatic (4)
    CL Item
    Relative (5)
    CL Item
    Not Applicable (6)
    Item
    If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
    integer
    C0205082 (UMLS CUI [1])
    If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
    Code List
    If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
    CL Item
    Assistance provided to the subject by a non-healthcare professional (e.g., relative, or non-relative) at the location of the hypoglycemic event. (1)
    CL Item
    Assistance provided to the subject by a healthcare professional (i.e., a nurse, physician, or emergency medical service was contacted and responded) at the location of the hypoglycemic event. (2)
    CL Item
    Event required an unscheduled visit to the investigator (but did not require hospitalization). (3)
    CL Item
    Event required a visit to another healthcare professional (but did not require hospitalization). (4)
    CL Item
    The event required a visit to the emergency room. (5)
    CL Item
    The subject required hospitalization (6)
    Required days of hospitalization
    Item
    Required days of hospitalization
    integer
    C0019993 (UMLS CUI [1])
    C0439228 (UMLS CUI [2])
    Item
    Intervention (enter the most severe, enter details on concomitant medication page if applicable)
    integer
    C0184661 (UMLS CUI [1])
    Intervention (enter the most severe, enter details on concomitant medication page if applicable)
    Code List
    Intervention (enter the most severe, enter details on concomitant medication page if applicable)
    CL Item
    None (1)
    CL Item
    Minor; Adminstered sugary drinks or sweets (2)
    CL Item
    Immediate; glucose drinks or suppliments (3)
    CL Item
    Extensive; glucose injection/ infusion/ glucagon (4)
    Item
    Action Taken with Background or Anti-Hyperglycemic Medication?
    integer
    C2826626 (UMLS CUI [1])
    Action Taken with Background or Anti-Hyperglycemic Medication?
    Code List
    Action Taken with Background or Anti-Hyperglycemic Medication?
    CL Item
    Yes (If yes, please update Anti-Hyperglycemic Medications page) (1)
    CL Item
    No (2)
    CL Item
    Not Applicable (3)
    Item Group
    Injection Site Reaction
    C0151735 (UMLS CUI-1)
    AE/SAE Number
    Item
    AE/SAE Number
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C0237753 (UMLS CUI [2,2])
    Date of injection
    Item
    Date of injection
    date
    C0011008 (UMLS CUI [1,1])
    C0021485 (UMLS CUI [1,2])
    Date of Reaction
    Item
    Date of Reaction
    date
    C0443286 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Size of skin reaction 1. diameter
    Item
    Size of skin reaction 1. diameter
    integer
    C0221743 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [2])
    Size of skin reaction 2. diameter
    Item
    Size of skin reaction 2. diameter
    integer
    C0221743 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [2])
    Item
    Location of injection
    integer
    C2700396 (UMLS CUI [1])
    Location of injection
    Code List
    Location of injection
    CL Item
    Left abdomen (1)
    CL Item
    Right abdomen (2)
    CL Item
    Other, specify (3)
    Specify other location of injection
    Item
    Specify other location of injection
    text
    C2700396 (UMLS CUI [1])
    C0205394 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    Was this local reaction within 24 hrs of dose?
    Item
    Was this local reaction within 24 hrs of dose?
    boolean
    C0853813 (UMLS CUI [1])
    C0178602 (UMLS CUI [2])
    Item
    Check all that apply regarding local reaction symptoms:
    integer
    C1457887 (UMLS CUI [1,1])
    C0853813 (UMLS CUI [1,2])
    Check all that apply regarding local reaction symptoms:
    Code List
    Check all that apply regarding local reaction symptoms:
    CL Item
    Redness/ Erythema Mild (1)
    CL Item
    Redness/ Erythema Moderate (2)
    CL Item
    Redness/ Erythema Severe (3)
    CL Item
    Itching/ Prutitus Mild (4)
    CL Item
    Itching/ Prutitus Moderate (5)
    CL Item
    Itching/ Prutitus Severe (6)
    CL Item
    Raised Mild (7)
    CL Item
    Raised Moderate (8)
    CL Item
    Raised Severe (9)
    CL Item
    Warmth Mild (10)
    CL Item
    Warmth Moderate (11)
    CL Item
    Warmth Severe (12)
    CL Item
    Other symptoms Mild (13)
    CL Item
    Other symptoms Moderate (14)
    CL Item
    Other symptoms Severe (15)
    Specify other symptoms
    Item
    Specify other symptoms
    text
    C1457887 (UMLS CUI [1])
    C0205394 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    Was treatment given for this local reaction?
    Item
    Was treatment given for this local reaction?
    boolean
    C0853813 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    Serum sample obtained?
    Item
    Serum sample obtained?
    boolean
    C0229671 (UMLS CUI [1])
    C0200345 (UMLS CUI [2])
    Provide date sample obtained
    Item
    Provide date sample obtained
    date
    C1302413 (UMLS CUI [1])
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