Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
SAVOR- TIMI 53
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
2 other identifiers
interventional
18,206
27 countries
536
Brief Summary
The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started May 2010
Typical duration for phase_4 type-2-diabetes-mellitus
536 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2010
CompletedFirst Posted
Study publicly available on registry
April 21, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
June 13, 2014
CompletedJuly 17, 2014
July 1, 2014
3 years
March 25, 2010
May 15, 2014
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Randomization (day 0) up to 2.9 years
Secondary Outcomes (2)
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
Randomization (day 0) up to 2.9 years
Participants With Event of Death
Randomization (day 0) up to 2.9 years
Study Arms (2)
Saxagliptin
EXPERIMENTALPlacebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
- Acute vascular event \<2months prior to randomisation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (536)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Alhambra, California, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Burlingame, California, United States
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Duarte, California, United States
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Huntington Park, California, United States
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La Mesa, California, United States
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Lomita, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Ramon, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Longmont, Colorado, United States
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Bridgeport, Connecticut, United States
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Bristol, Connecticut, United States
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Southington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Coral Springs, Florida, United States
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Daytona Beach, Florida, United States
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Deerfield Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Green Cove Springs, Florida, United States
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Hialeah, Florida, United States
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Hudson, Florida, United States
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Naples, Florida, United States
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Related Publications (15)
Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030. No abstract available.
PMID: 33832610DERIVEDBerg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.
PMID: 31474116DERIVEDBergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.
PMID: 31362530DERIVEDScirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjostrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.
PMID: 29214305DERIVEDXia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4.
PMID: 28417296DERIVEDMosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.
PMID: 27797925DERIVEDScirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.
PMID: 27681000DERIVEDCavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.
PMID: 26524706DERIVEDMosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.
PMID: 26358285DERIVEDLeiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.
PMID: 25758769DERIVEDUdell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.
PMID: 25552421DERIVEDScirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4.
PMID: 25189213DERIVEDScirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.
PMID: 23992601DERIVEDMosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.
PMID: 23564755DERIVEDScirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.
PMID: 22093196DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirshberg MD, MBA
- Organization
- AstraZeneca LP
Study Officials
- STUDY CHAIR
Eugene Braunwald
TIMI
- PRINCIPAL INVESTIGATOR
Itamar Raz
Hadassah Medical Organization
- PRINCIPAL INVESTIGATOR
Deepak Bhatt
TIMI
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2010
First Posted
April 21, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
July 17, 2014
Results First Posted
June 13, 2014
Record last verified: 2014-07