ID
32511
Beschreibung
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
Stichworte
Versionen (2)
- 08.10.18 08.10.18 -
- 06.11.18 06.11.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
6. November 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229
Day 2
- StudyEvent: ODM
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Date in time
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Systolic Pressuure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
text
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Electronically transferred laboratory data - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beschreibung
Electronically transferred laboratory data - Haematology
Alias
- UMLS CUI-1
- C0474523
Beschreibung
Electronically transferred laboratory data - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschreibung
Capillary Blood Glucose
Alias
- UMLS CUI-1
- C0457578
Beschreibung
Capillary Blood Glucose measurement; Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0011008
Beschreibung
Capillary Blood Glucose measurement; relative time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0439564
Beschreibung
Capillary Blood Glucose measurement; Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C0040223
Beschreibung
Capillary Blood Glucose measurement; Result
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C1274040
Beschreibung
Capillary Blood Glucose measurement; Unit of measure
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0457578
- UMLS CUI [1,2]
- C1519795
Beschreibung
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
Beschreibung
Pharmacodynamics; relative time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0439564
Beschreibung
Pharmacokinetic aspects; Blood; Sampling; Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beschreibung
Pharmacokinetic aspects; Blood; Sampling; Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Beschreibung
Pharmacokinetic aspects; Blood; Sample identification number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C1299222
Beschreibung
Pharmacodynamics - Blood [GLP-1 Total]
Alias
- UMLS CUI-1
- C0851347
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0061355
Beschreibung
Pharmacodynamics; relative time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0439564
Beschreibung
Pharmacokinetic aspects; Blood; Sampling; Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beschreibung
Pharmacokinetic aspects; Blood; Sampling; Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0040223
Beschreibung
Pharmacokinetic aspects; Blood; Sample identification number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0851347
- UMLS CUI [1,2]
- C1299222
Beschreibung
Bioactivity Sampling; Blood
Alias
- UMLS CUI-1
- C0599112
- UMLS CUI-2
- C0005834
Beschreibung
drug biological activity; Collection of blood specimen for laboratory procedure; relative time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0439564
Beschreibung
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
Beschreibung
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0040223
Beschreibung
drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0599112
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C1299222
Beschreibung
Pharmacokinetic aspects; Blood (GLP-1 total)
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0061355
Beschreibung
Pharmacokinetic aspects; Blood; relative time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0439564
Beschreibung
Pharmacokinetic aspects; Blood; Sampling; Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Beschreibung
Pharmacokinetic aspects; Blood; Sampling; Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0040223
Beschreibung
Pharmacokinetic aspects; Blood; Sample identification number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C1299222
Beschreibung
Anti-Diabetic Agent Tolerability Scale (ADATS)
Alias
- UMLS CUI-1
- C0935929
- UMLS CUI-2
- C3274448
Beschreibung
Antidiabetics; Tolerability Study;Date in Time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0935929
- UMLS CUI [1,2]
- C3274448
- UMLS CUI [1,3]
- C0011008
Beschreibung
Adverse event; Serious Adverse Event; Hypoglycaemic episode
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0745153
Beschreibung
Adverse event; Quantity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1265611
Beschreibung
Adverse events
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Adverse event; Page, Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704732
- UMLS CUI [1,3]
- C0237753
Beschreibung
Adverse event; row (table), number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1552840
- UMLS CUI [1,3]
- C0237753
Beschreibung
Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
Alias
- UMLS CUI-1
- C0935929
- UMLS CUI-2
- C3274448
- UMLS CUI-3
- C2349155
Beschreibung
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Datentyp
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
Beschreibung
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Datentyp
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
Beschreibung
Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome
Datentyp
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
Beschreibung
Experimental drug; Adverse reaction to drug; Impaired
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0041755
- UMLS CUI [1,3]
- C0221099
Ähnliche Modelle
Day 2
- 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])