Last updated: 02/04/2020 18:50:25
Analysis Plan for the Integrated Analysis of Cardiovascular Risk Among Type II Diabetes Subjects Exposed to GSK716155 in the Phase III Program
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Analysis Plan for the Integrated Analysis of Cardiovascular Risk Among Type II Diabetes Subjects Exposed to GSK716155 in the Phase III Program
Trial description: Analyses of cardiovascular safety data among type II diabetic subjects who participate in the GlaxoSmithKline (GSK) albiglutide program. Results of these analyses will be reviewed to rule out excess cardiovascular risk of albiglutide relative to combined comparators
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
MACE+
Timeframe: 3 years
Secondary outcomes:
MI
Timeframe: 3 years
All cause mortality
Timeframe: 3 years
CV death
Timeframe: 3 years
MACE
Timeframe: 3 years
Unstable angina
Timeframe: 3 years
Stroke
Timeframe: 3 years
Interventions:
Drug: Albiglutide
Drug: Active comparators
Drug: Placebo
Enrollment:
0
Observational study model:
Other
Primary completion date:
2013-27-08
Time perspective:
Prospective
Clinical publications:
Miles Fisher, Mark Petrie, Philip D Ambery, Jill Donaldson, June Ye, John JV McMurray. Cardiovascular safety of albiglutide: results of the HARMONY Program prospective major adverse cardiovascular event meta-analysis. Lancet Diabetes Endocrinol. 2015;3(9):697-703.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
June 2013 to August 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Diagnosed with type 2 diabetes
- Participated in the GSK albiglutide clinical program
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosed with type 2 diabetes
- Participated in the GSK albiglutide clinical program
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2013-27-08
Actual study completion date
2013-27-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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