Type 2 Diabetes MellitusPhase 4SAVOR- TIMI 53NCT01107886

Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

A Phase 4 study testing Saxagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 536 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Saxagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18,206 participants
Where: 536 sitesin 27 countries
Study dates: May 2010to May 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

536 sites in 27 countries.

Country

City, postcode or hospital

536 sites in 27 countries

United States202 sites

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Albuquerque, New Mexico
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Alhambra, California
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Alpena, Michigan
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Altoona, Pennsylvania
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Amarillo, Texas
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Anaheim, California
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Arlington, Texas
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Auburn, Maine
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Austin, Texas
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Avon, Indiana
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Ayer, Massachusetts
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Bakersfield, California
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Baltimore, Maryland
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Bangor, Maine
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Baxter, Minnesota
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Beachwood, Ohio
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Belleville, Illinois
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Bellevue, Nebraska
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Bethlehem, Pennsylvania
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Billings, Montana
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Binghamton, New York
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Birmingham, Alabama
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Boston, Massachusetts
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Bridgeport, Connecticut
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Bristol, Connecticut
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Bristol, Tennessee
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Buffalo, New York
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Burien, Washington
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Burke, Virginia
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Burlingame, California
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Cadillac, Michigan
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Cadiz, Ohio
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Canal Fulton, Ohio
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Canton, Ohio
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Charleston, South Carolina
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Charlotte, North Carolina
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Chaska, Minnesota
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Chicago, Illinois
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Cincinnati, Ohio
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Clymer, Pennsylvania
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Colleyville, Texas
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Colorado Springs, Colorado
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Columbia, South Carolina
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Columbus, Ohio
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Conyers, Georgia
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Coral Springs, Florida
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Cortlandt Manor, New York
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Council Bluffs, Iowa
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Cumming, Georgia
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Dallas, Texas
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Dayton, Ohio
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Daytona Beach, Florida
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Deerfield Beach, Florida
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Delaware, Ohio
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Denver, Colorado
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Doylestown, Pennsylvania
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Duarte, California
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Duluth, Minnesota
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Durham, North Carolina
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Eagan, Minnesota
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Edinburg, Texas
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Elizabeth, New Jersey
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Elmer, New Jersey
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Elyria, Ohio
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Endwell, New York
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Evansville, Indiana
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Evansville, Kentucky
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Federal Way, Washington
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Fishers, Indiana
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Fort Lauderdale, Florida
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Fort Wayne, Indiana
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Fort Worth, Texas
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Franklin, Indiana
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Fremont, Nebraska
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Georgetown, Texas
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Grand Forks, North Dakota
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Grand Island, Nebraska
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Grapevine, Texas
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Green Cove Springs, Florida
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Greenfield, Indiana
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Greer, South Carolina
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Haverhill, Massachusetts
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Hayden Lake, Idaho
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Henderson, Nevada
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Hermitage, Pennsylvania
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Hialeah, Florida
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Hickory, North Carolina
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Honolulu, Hawaii
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Houston, Texas
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Hudson, Florida
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Huntington Park, California
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Indiana, Pennsylvania
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Irving, Texas
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Jackson, Tennessee
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Jacksonville, Florida
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Jersey Shore, Pennsylvania
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Johnstown, Pennsylvania
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Kalamazoo, Michigan
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Kansas City, Missouri
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Katy, Texas
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Kenner, Louisiana
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Kettering, Ohio
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La Mesa, California
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Las Vegas, Nevada
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Leesburg, Florida
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Little Rock, Arkansas
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Lomita, California
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Longmont, Colorado
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Lorain, Ohio
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Los Angeles, California
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Manassas, Virginia
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McAllen, Texas
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Memphis, Tennessee
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Miami, Florida
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Middleburg Hights, Ohio
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Midland, Texas
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Midlothian, Virginia
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Mission, Texas
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Monroe, North Carolina
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Morganton, North Carolina
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Naples, Florida
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Nashville, Tennessee
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Natick, Massachusetts
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New Hyde Park, New York
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Newton, Kansas
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Niles, Illinois
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Norfolk, Virginia
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North Dartmouth, Massachusetts
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Northport, New York
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Oakland Park, Florida
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Ocala, Florida
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Oceanside, California
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Odessa, Texas
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Palm Beach Gardens, Florida
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Pembroke Pines, Florida
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Petosky, Michigan
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Philadelphia, Pennsylvania
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Plant City, Florida
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Pocatello, Idaho
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Portland, Maine
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Providence, Rhode Island
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Richardson, Texas
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Richmond, Virginia
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Robbinsdale, Minnesota
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Rochester, Michigan
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Sandusky, Ohio
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Shreveport, Louisiana
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Slidell, Louisiana
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Southlake, Texas
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Spartenburg, South Carolina
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St. Petersburg, Florida
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Tempe, Arizona
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Valparaiso, Indiana
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Victoria, Texas
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Waterford, Michigan
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Winter Haven, Florida
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Canada34 sites

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Netherlands22 sites

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Delft
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Goes
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Nijmegen
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Italy20 sites

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Poland20 sites

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Germany19 sites

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Mayen
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Morón
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Hungary15 sites

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Israel14 sites

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About this study

Official 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

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

Read the detailed description

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: Type 2 Diabetes Mellitus
Being tested: Saxagliptin, Placebo
Keywords: Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SaxagliptinDrug
Also called Onglyza
5 mg or 2.5 mg once daily
PlaceboDrug

Study groups in NCT01107886
Study group	Role	What they receive
Saxagliptin	Experimental	Not described Receives: Drug: Saxagliptin
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Measured: Randomization (day 0) up to 2.9 years
Participants With Event of Death
Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.
Measured: Randomization (day 0) up to 2.9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010May 2013

First posted21 Apr 2010 (estimated)
Study startMay 2010
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18,206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01107886
Sponsor's protocol ID: D1680C00003
Other IDs: EudraCT No 2009-017358-10
Acronym: SAVOR- TIMI 53
Status last verified: Jul 2014
First submitted: 25 Mar 2010
Last updated: 17 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 33832610
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.
PubMed 31474116
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.
PubMed 31362530
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.
PubMed 29214305
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.
PubMed 28417296
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.
PubMed 27797925
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.
PubMed 27681000
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.
PubMed 26524706
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.
PubMed 26358285
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.
PubMed 25758769
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.
PubMed 25552421
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.
PubMed 25189213
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.
PubMed 23992601
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.
PubMed 23564755
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.
PubMed 22093196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01107886
Acronym / sponsor ID: SAVOR- TIMI 53 / D1680C00003
Conditions: Type 2 Diabetes Mellitus
Keywords: Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18,206 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: May 2010
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 21 Apr 2010 (estimated)
Results: Posted 13 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Saxagliptin	Experimental	Drug: Saxagliptin
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SaxagliptinAlso: Onglyza5 mg or 2.5 mg once daily	Drug	Saxagliptin
Placebo	Drug	Placebo

Primary outcome

Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Time frame: Randomization (day 0) up to 2.9 years
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.

2 secondary outcomes

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
Time frame: Randomization (day 0) up to 2.9 years
Participants With Event of Death
Time frame: Randomization (day 0) up to 2.9 years

Results and safety

Results posted to the registry on 13 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saxagliptin	8,280	8,078
Placebo	8,212	7,998

Primary outcome: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke

Time frame: Randomization (day 0) up to 2.9 years. Number. Unit: participants

Measure	Saxagliptin n = 8280	Placebo n = 8212
Value	613	609

Population analysed: Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2,075 of 8,212 (25.3%)	3,641 of 8,212 (44.3%)	Not reported
Saxagliptin	2,114 of 8,280 (25.5%)	3,504 of 8,280 (42.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33832610Cavallari 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.
Derived from this study: PubMed 31474116Berg 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.
Derived from this study: PubMed 31362530Bergmark 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.
Derived from this study: PubMed 29214305Scirica 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.
Derived from this study: PubMed 28417296Xia 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.
Derived from this study: PubMed 27797925Mosenzon 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.
Derived from this study: PubMed 27681000Scirica 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.
Derived from this study: PubMed 26524706Cavender 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.
Derived from this study: PubMed 26358285Mosenzon 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.
Derived from this study: PubMed 25758769Leiter 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.
Derived from this study: PubMed 25552421Udell 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.
Derived from this study: PubMed 25189213Scirica 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.
D1680C00003 Clinical Study ProtocolLink provided by the sponsor.
Related InfoLink provided by the sponsor.
D1680C00003\_CSR\_SynopsisLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugene Braunwald study chair

TIMI

Itamar Raz principal investigator

Hadassah Medical Organization

Deepak Bhatt principal investigator

TIMI

536 sites in 27 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 536 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 536 sites in United States, Canada, Czechia, Netherlands, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke (time frame: Randomization (day 0) up to 2.9 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01107886, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.