ID

32514

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

Keywords

Versions (3)
  1. 10/5/18 10/5/18 -
  2. 11/6/18 11/6/18 -
  3. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

DOI

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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 1

1 forms  
  1. StudyEvent: ODM
    1. Day 1
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number
Description

undefined item

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Description

Randomization; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
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
48-hr Telemetry ECG
Description

48-hr Telemetry ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0039451
Start Date of ECG
Description

Electrocardiogram; Telemetry; Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C0808070
Start Time of ECG
Description

Electrocardiogram; Telemetry; Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C1301880
End Date of ECG
Description

Electrocardiogram; Telemetry; End Date

Data type

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C0806020
End time of ECG
Description

Electrocardiogram; Telemetry; End Time

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C1522314
Result of the ECG
Description

Electrocardiogram; Telemetry; Result

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
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
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
UMLS CUI-3
C1299222
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
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint (e.g. Day 1)
Description

Experimental Drug; Timepoint, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1301732
Date of Injection
Description

Experimental Drug; Injection procedure; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0011008
Time of Injection
Description

Experimental Drug; Injection procedure; Date in time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0040223
Dose
Description

Experimental Drug; Medication dose

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3174092
mg
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Therapeutic procedure; Confirmation

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
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Similar models

Day 1

1 forms
  1. StudyEvent: ODM
    1. Day 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
undefined item
Item
Record randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomization; Date in time
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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
48-hr Telemetry ECG
C1623258 (UMLS CUI-1)
C0039451 (UMLS CUI-2)
Electrocardiogram; Telemetry; Start Date
Item
Start Date of ECG
date
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; Start Time
Item
Start Time of ECG
time
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; End Date
Item
End Date of ECG
date
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; End Time
Item
End time of ECG
time
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Result of the ECG
text
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal - clinically significant  (3)
CL Item
No result (not available) (4)
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
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)
C1299222 (UMLS CUI-3)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; relative time
Code List
Planned Relative Time
CL Item
Predose (1)
CL Item
3.5 hr (2)
CL Item
8.5 hr (3)
CL Item
18.5 hr (4)
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])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sample identification number
Code List
Sample Number
CL Item
101 (1)
CL Item
102 (2)
CL Item
103 (3)
CL Item
104 (4)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Experimental Drug; Timepoint, Planned
Item
Planned Timepoint (e.g. Day 1)
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental Drug; Injection procedure; Date in time
Item
Date of Injection
date
C0304229 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental Drug; Injection procedure; Date in time
Item
Time of Injection
time
C0304229 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Experimental Drug; Medication dose
Item
Dose
integer
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic procedure; Confirmation
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Yes)
CL Item
No (give reasons) (No (give reasons))
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