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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-05-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saxagliptin

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

5 mg or 2.5 mg once daily

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Saxagliptin

5 mg or 2.5 mg once daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Onglyza

Eligibility Criteria

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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

Exclusion Criteria

* Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
* Acute vascular event \<2months prior to randomisation
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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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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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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Winter Park, Florida, United States

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Conyers, Georgia, United States

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Cumming, Georgia, United States

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Honolulu, Hawaii, United States

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Hayden Lake, Idaho, United States

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Pocatello, Idaho, United States

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Belleville, Illinois, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Fishers, Indiana, United States

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Greenfield, Indiana, United States

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Council Bluffs, Iowa, United States

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Newton, Kansas, United States

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Evansville, Kentucky, United States

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Kenner, Louisiana, United States

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Shreveport, Louisiana, United States

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Slidell, Louisiana, United States

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Auburn, Maine, United States

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Bangor, Maine, United States

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Portland, Maine, United States

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Towson, Maryland, United States

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Ayer, Massachusetts, United States

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Boston, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Natick, Massachusetts, United States

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Robbinsdale, Minnesota, United States

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Reno, Nevada, United States

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Elizabeth, New Jersey, United States

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Albuquerque, New Mexico, United States

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Greer, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Memphis, Tennessee, United States

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Midlothian, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Federal Way, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Ciudad Autonom de Buenos Aires, , Argentina

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CiudadAutonoma de Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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La Plata, , Argentina

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Mar del Plata, , Argentina

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Goiânia, , Brazil

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Calgary, Alberta, Canada

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Spruce Grove, Alberta, Canada

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Santiago, , Chile

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Temuco, , Chile

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References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33832610 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31474116 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31362530 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29214305 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28417296 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27797925 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27681000 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26524706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26358285 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25758769 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25552421 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25189213 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23992601 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23564755 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22093196 (View on PubMed)

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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