|
gptkbp:instance_of
|
gptkb:Clinical_Trials
|
|
gptkbp:aimed_to_evaluate
|
cardiovascular outcomes
|
|
gptkbp:analysis
|
TIMI Study Group
|
|
gptkbp:clinical_trial
|
NCT01107886
|
|
gptkbp:collaborator
|
gptkb:Eli_Lilly
gptkb:Takeda_Pharmaceutical_Company
gptkb:Astra_Zeneca
gptkb:Sanofi
gptkb:Bristol-Myers_Squibb
gptkb:Daiichi_Sankyo
gptkb:Glaxo_Smith_Kline
|
|
gptkbp:collection
|
clinical assessments
laboratory tests
patient-reported outcomes
|
|
gptkbp:completed
|
gptkb:2014
|
|
gptkbp:conducted
|
multiple countries
|
|
gptkbp:criteria
|
type 2 diabetes
history of heart failure
|
|
gptkbp:enrollment_period
|
2010-2013
|
|
gptkbp:events
|
median 2.1 years
|
|
gptkbp:finale_date
|
hospitalization for heart failure
major adverse cardiovascular events
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
SAVOR-TIMI 53
|
|
gptkbp:investigated_drug
|
gptkb:saxagliptin
placebo
|
|
gptkbp:investigates
|
Dr. Steven E. Nissen
|
|
gptkbp:is_focused_on
|
gptkb:saxagliptin
|
|
gptkbp:is_funded_by
|
gptkb:National_Institutes_of_Health
|
|
gptkbp:is_studied_in
|
double-blind
|
|
gptkbp:location
|
gptkb:Europe
gptkb:Asia
gptkb:North_America
|
|
gptkbp:participants
|
safety and efficacy
16,492
|
|
gptkbp:provides_guidance_on
|
diabetes management guidelines
cardiovascular risk management guidelines
|
|
gptkbp:published_in
|
gptkb:The_New_England_Journal_of_Medicine
|
|
gptkbp:regulatory_compliance
|
FDA approval
EMA approval
|
|
gptkbp:result
|
gptkb:2014
|
|
gptkbp:resulted_in
|
saxagliptin associated with increased hospitalization for heart failure
saxagliptin not increasing cardiovascular risk
|
|
gptkbp:sponsored_by
|
gptkb:Merck_&_Co.
|
|
gptkbp:started_in
|
gptkb:2010
|
|
gptkbp:study_phase
|
Phase III
|
|
gptkbp:topics
|
EXAMINE trial
CARMELINA trial
CAROLINA trial
CREDENCE trial
DECLARE-TIMI 58
HARMONY trial
LEADER trial
REWIND trial
SUSTAIN-6 trial
VIVID trial
|
|
gptkbp:type_of_study
|
randomized controlled trial
|
|
gptkbp:bfsParent
|
gptkb:Sitagliptin
|
|
gptkbp:bfsLayer
|
7
|