Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
NCT ID: NCT01107886
Last Updated: 2014-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
18206 participants
INTERVENTIONAL
2010-05-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Saxagliptin
Saxagliptin
5 mg or 2.5 mg once daily
Placebo
Placebo
Placebo
Interventions
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Saxagliptin
5 mg or 2.5 mg once daily
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Acute vascular event \<2months prior to randomisation
40 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Eugene Braunwald
Role: STUDY_CHAIR
TIMI
Itamar Raz
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Deepak Bhatt
Role: PRINCIPAL_INVESTIGATOR
TIMI
Locations
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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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Duarte, 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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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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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Oakland Park, Florida, United States
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Ocala, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pembroke Pines, Florida, United States
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Plant City, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Trinity, Florida, United States
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West Palm Beach, Florida, United States
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Weston, Florida, United States
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Winter Haven, Florida, United States
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References
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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.
Berg 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.
Bergmark 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.
Scirica 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.
Xia 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.
Mosenzon 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.
Scirica 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.
Cavender 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.
Mosenzon 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.
Leiter 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.
Udell 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.
Scirica 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.
Scirica 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.
Mosenzon 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.
Scirica 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.
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D1680C00003 Clinical Study Protocol
Other Identifiers
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EudraCT No 2009-017358-10
Identifier Type: -
Identifier Source: secondary_id
D1680C00003
Identifier Type: -
Identifier Source: org_study_id
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