ID
31928
Beschrijving
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
Trefwoorden
Versies (3)
- 08-10-18 08-10-18 -
- 08-10-18 08-10-18 -
- 06-11-18 06-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 oktober 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229
Day 9
- StudyEvent: ODM
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Date in time
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Heart rate
Datatype
text
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Electronically transferred laboratory data - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beschrijving
Electronically transferred laboratory data - Haematology
Alias
- UMLS CUI-1
- C0474523
Beschrijving
Electronically transferred laboratory data - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Capillary Blood Glucose
Alias
- UMLS CUI-1
- C0457578
Beschrijving
Capillary Blood Glucose measurement; Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0011008
Beschrijving
Capillary Blood Glucose measurement; relative time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0439564
Beschrijving
Capillary Blood Glucose measurement; Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0040223
Beschrijving
Capillary Blood Glucose measurement; Result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C1274040
Beschrijving
Capillary Blood Glucose measurement; Unit of measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C1519795
Beschrijving
Pharmacodynamics - Blood [Glucose, Glucagon, Insulin, C-Peptide]
Alias
- UMLS CUI-1
- C0851347
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0017725
- UMLS CUI-4
- C0017687
- UMLS CUI-5
- C0021641
- UMLS CUI-6
- C0006558
Beschrijving
Pharmacodynamics; relative time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0439564
Beschrijving
Pharmacokinetic aspects; Blood; Sampling; Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beschrijving
Pharmacokinetic aspects; Blood; Sampling; Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Beschrijving
Pharmacokinetic aspects; Blood; Sample identification number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C1299222
Beschrijving
Pharmacodynamics - Blood [GLP-1 Total]
Alias
- UMLS CUI-1
- C0851347
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0061355
Beschrijving
Pharmacodynamics; relative time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0439564
Beschrijving
Pharmacokinetic aspects; Blood; Sampling; Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beschrijving
Pharmacokinetic aspects; Blood; Sampling; Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Beschrijving
Pharmacokinetic aspects; Blood; Sample identification number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C1299222
Beschrijving
Bioactivity Sampling; Blood
Alias
- UMLS CUI-1
- C0599112
- UMLS CUI-2
- C0005834
Beschrijving
drug biological activity; Collection of blood specimen for laboratory procedure; relative time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0439564
Beschrijving
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
Beschrijving
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0040223
Beschrijving
drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C1299222
Beschrijving
Pharmacokinetic aspects; Blood (GLP-1 total)
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0061355
Beschrijving
Pharmacokinetic aspects; Blood; relative time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0439564
Beschrijving
Pharmacokinetic aspects; Blood; Sampling; Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Beschrijving
Pharmacokinetic aspects; Blood; Sampling; Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Beschrijving
Pharmacokinetic aspects; Blood; Sample identification number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C1299222
Beschrijving
Anti-Diabetic Agent Tolerability Scale (ADATS)
Alias
- UMLS CUI-1
- C0935929
- UMLS CUI-2
- C3274448
Beschrijving
Antidiabetics; Tolerability Study;Date in Time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0935929
- UMLS CUI [1,2]
- C3274448
- UMLS CUI [1,3]
- C0011008
Beschrijving
Adverse event; Serious Adverse Event; Hypoglycaemic episode
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0745153
Beschrijving
Adverse event; Quantity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1265611
Beschrijving
Adverse events
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Adverse event; Page, Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704732
- UMLS CUI [1,3]
- C0237753
Beschrijving
Adverse event; row (table), number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1552840
- UMLS CUI [1,3]
- C0237753
Beschrijving
Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
Alias
- UMLS CUI-1
- C0935929
- UMLS CUI-2
- C3274448
- UMLS CUI-3
- C2349155
Beschrijving
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4489383
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C4489382
- UMLS CUI [3,1]
- C0877248
- UMLS CUI [3,2]
- C4489381
- UMLS CUI [4,1]
- C0877248
- UMLS CUI [4,2]
- C4489380
- UMLS CUI [5,1]
- C0877248
- UMLS CUI [5,2]
- C4489379
Beschrijving
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4489383
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C4489382
- UMLS CUI [3,1]
- C0877248
- UMLS CUI [3,2]
- C4489381
- UMLS CUI [4,1]
- C0877248
- UMLS CUI [4,2]
- C4489380
- UMLS CUI [5,1]
- C0877248
- UMLS CUI [5,2]
- C4489379
Beschrijving
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4489383
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C4489382
- UMLS CUI [3,1]
- C0877248
- UMLS CUI [3,2]
- C4489381
- UMLS CUI [4,1]
- C0877248
- UMLS CUI [4,2]
- C4489380
- UMLS CUI [5,1]
- C0877248
- UMLS CUI [5,2]
- C4489379
Beschrijving
Experimental drug; Adverse reaction to drug; Impaired
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0041755
- UMLS CUI [1,3]
- C0221099
Similar models
Day 9
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0017725 (UMLS CUI-3)
C0017687 (UMLS CUI-4)
C0021641 (UMLS CUI-5)
C0006558 (UMLS CUI-6)
C0439564 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0061355 (UMLS CUI-3)
C0439564 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,2])
C0005834 (UMLS CUI-2)
C0005834 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C0031328 (UMLS CUI-2)
C0061355 (UMLS CUI-3)
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C3274448 (UMLS CUI-2)
C3274448 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
C0745153 (UMLS CUI [3])
C1265611 (UMLS CUI [1,2])
C1704732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1552840 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C3274448 (UMLS CUI-2)
C2349155 (UMLS CUI-3)
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
C0041755 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])