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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01107886




Registration number
NCT01107886
Ethics application status
Date submitted
25/03/2010
Date registered
21/04/2010
Date last updated
17/07/2014

Titles & IDs
Public title
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
Scientific title
A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Secondary ID [1] 0 0
EudraCT No 2009-017358-10
Secondary ID [2] 0 0
D1680C00003
Universal Trial Number (UTN)
Trial acronym
SAVOR- TIMI 53
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Saxagliptin

Experimental: Saxagliptin -

Placebo comparator: Placebo - Placebo


Treatment: Drugs: Saxagliptin
5 mg or 2.5 mg once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Timepoint [1] 0 0
Randomization (day 0) up to 2.9 years
Secondary outcome [1] 0 0
Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation
Timepoint [1] 0 0
Randomization (day 0) up to 2.9 years
Secondary outcome [2] 0 0
Participants With Event of Death
Timepoint [2] 0 0
Randomization (day 0) up to 2.9 years

Eligibility
Key inclusion criteria
* Patients with type 2 diabetes mellitus
* HbA1c =6.5%. (based on the last measured and documented laboratory measurement within 6 months)
* High risk for CV events -Established cardiovascular disease and/or multiple risk factors
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
* Acute vascular event <2months prior to randomisation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Ashford
Recruitment hospital [2] 0 0
Research Site - Fitzroy
Recruitment hospital [3] 0 0
Research Site - Frankston
Recruitment hospital [4] 0 0
Research Site - Garran
Recruitment hospital [5] 0 0
Research Site - Geelong
Recruitment hospital [6] 0 0
Research Site - Launceston
Recruitment hospital [7] 0 0
Research Site - Maroubra
Recruitment hospital [8] 0 0
Research Site - Milton
Recruitment hospital [9] 0 0
Research Site - Sherwood
Recruitment hospital [10] 0 0
Research Site - Southport
Recruitment hospital [11] 0 0
Research Site - Windsor
Recruitment postcode(s) [1] 0 0
- Ashford
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- Fitzroy
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- Frankston
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- Garran
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- Geelong
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- Launceston
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- Maroubra
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- Milton
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- Sherwood
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- Southport
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- Windsor
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Netherlands
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Callao
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Peru
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Lima
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Peru
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San Isidro
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Kamieniec Zabkowicki
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Poland
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Poland
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Poland
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Bangkok
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Whitstable

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eugene Braunwald
Address 0 0
TIMI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.