ID
31962
Descripción
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
Palabras clave
Versiones (1)
- 9/10/18 9/10/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
9 de octubre de 2018
DOI
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Licencia
Creative Commons BY-NC 3.0
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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229
Day 13
- StudyEvent: ODM
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Body Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Date in time
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
Vital Signs; Relative Time
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Descripción
Vital Signs Time
Tipo de datos
time
Alias
- UMLS CUI [1]
- C2826762
Descripción
Systolic Pressure
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descripción
Diastolic Blood Pressure
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descripción
Heart rate
Tipo de datos
text
Unidades de medida
- bpm
Alias
- UMLS CUI [1]
- C0018810
Descripción
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Descripción
Electronically transferred laboratory data - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Descripción
Electronically transferred laboratory data - Haematology
Alias
- UMLS CUI-1
- C0474523
Descripción
Electronically transferred laboratory data - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Descripción
Electronically transferred Laboratory Data - Free Fatty Acids
Alias
- UMLS CUI-1
- C0373606
Descripción
Free Fatty Acids measurement; Sampling; Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0373606
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Descripción
Free Fatty Acids measurement; Sampling; Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0373606
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Descripción
Electronically transferred Laboratory Data - Fructosamine
Alias
- UMLS CUI-1
- C0202025
Descripción
Fructosamine measurement; Sampling, Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0202025
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Descripción
Fructosamine measurement; Sampling; Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0202025
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Descripción
Capillary Blood Glucose
Alias
- UMLS CUI-1
- C0457578
Descripción
Capillary Blood Glucose measurement; Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0011008
Descripción
Capillary Blood Glucose measurement; relative time
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0439564
Descripción
Capillary Blood Glucose measurement; Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0040223
Descripción
Capillary Blood Glucose measurement; Result
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C1274040
Descripción
Capillary Blood Glucose measurement; Unit of measure
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C1519795
Descripción
Bioactivity Sampling; Blood
Alias
- UMLS CUI-1
- C0599112
- UMLS CUI-2
- C0005834
Descripción
drug biological activity; Collection of blood specimen for laboratory procedure; relative time
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0439564
Descripción
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
Descripción
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0040223
Descripción
drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C1299222
Descripción
Pharmacokinetic aspects; Blood (GLP-1 total)
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0061355
Descripción
Pharmacokinetic aspects; Blood; relative time
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0439564
Descripción
Pharmacokinetic aspects; Blood; Sampling; Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Descripción
Pharmacokinetic aspects; Blood; Sampling; Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Descripción
Pharmacokinetic aspects; Blood; Sample identification number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C1299222
Descripción
Anti-Diabetic Agent Tolerability Scale (ADATS)
Alias
- UMLS CUI-1
- C0935929
- UMLS CUI-2
- C3274448
Descripción
Antidiabetics; Tolerability Study;Date in Time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0935929
- UMLS CUI [1,2]
- C3274448
- UMLS CUI [1,3]
- C0011008
Descripción
Adverse event; Serious Adverse Event; Hypoglycaemic episode
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0745153
Descripción
Adverse event; Quantity
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1265611
Descripción
Adverse events
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
Adverse event; Page, Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704732
- UMLS CUI [1,3]
- C0237753
Descripción
Adverse event; row (table), number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1552840
- UMLS CUI [1,3]
- C0237753
Descripción
Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
Alias
- UMLS CUI-1
- C0935929
- UMLS CUI-2
- C3274448
- UMLS CUI-3
- C2349155
Descripción
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Tipo de datos
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
Descripción
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Tipo de datos
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
Descripción
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Tipo de datos
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
Descripción
Experimental drug; Adverse reaction to drug; Impaired
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0041755
- UMLS CUI [1,3]
- C0221099
Similar models
Day 13
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301880 (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])
C0439564 (UMLS CUI [1,2])
C0456984 (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])
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])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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])
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])