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

Type 2 Diabetes Mellitus Clinical Trial

— SAVOR- TIMI 53  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107886
• Other study ID #: D1680C00003
• Secondary ID: EudraCT No 2009-
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2010
• Last updated: July 9, 2014
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBrazil: Ministry of HealthCanada: Health CanadaChile: Instituto de Salud Pública de ChileChina: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlFrance: Ministry of HealthGermany: Ethics CommissionHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaIsrael: Ministry of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: Federal Commission for Protection Against Health RisksNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Peru: Instituto Nacional de SaludPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control CouncilSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencyTaiwan: Department of HealthThailand: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18206
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Saxagliptin
5 mg or 2.5 mg once daily
• Placebo

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad Autonom de Buenos Aires
Argentina	Research Site	CiudadAutonoma de Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Corrientes
Argentina	Research Site	La Plata
Argentina	Research Site	Lanus Buenos Aires
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Morón
Argentina	Research Site	Ramos Mejía
Argentina	Research Site	Rosario
Argentina	Research Site	Rosario Santa Fe
Argentina	Research Site	Santa Fe
Argentina	Research Site	Sarandi Buenos Aires
Argentina	Research Site	Villa Ballester
Australia	Research Site	Ashford
Australia	Research Site	Fitzroy
Australia	Research Site	Frankston
Australia	Research Site	Garran
Australia	Research Site	Geelong
Australia	Research Site	Launceston
Australia	Research Site	Maroubra
Australia	Research Site	Milton
Australia	Research Site	Sherwood
Australia	Research Site	Southport
Australia	Research Site	Windsor
Brazil	Research Site	Belem
Brazil	Research Site	Brasilia
Brazil	Research Site	Campinas
Brazil	Research Site	Curitiba
Brazil	Research Site	Goiânia
Brazil	Research Site	Marilia
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Recife
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Brossard	Quebec
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Longueuil	Quebec
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	New Westminster	British Columbia
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Red Deer	Alberta
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Saint-Charles-Borromee	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Smiths Falls	Ontario
Canada	Research Site	Spruce Grove	Alberta
Canada	Research Site	St-Lambert	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Winnipeg	Manitoba
Chile	Research Site	Santiago
Chile	Research Site	Temuco
China	Research Site	Beijing
China	Research Site	Changsha
China	Research Site	Guangzhou
China	Research Site	Hong Kong
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Suzhou
China	Research Site	Tianjin
Czech Republic	Research Site	Beroun
Czech Republic	Research Site	Blansko
Czech Republic	Research Site	Breclav
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Caslav
Czech Republic	Research Site	Cheb
Czech Republic	Research Site	Chrudim III
Czech Republic	Research Site	Havirov
Czech Republic	Research Site	Hodonin
Czech Republic	Research Site	Horovice
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Jablonec nad Nisou
Czech Republic	Research Site	Kromeriz
Czech Republic	Research Site	Olomouc-Lazce
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Ostrava - Belsky les
Czech Republic	Research Site	Ostrava - Kuncice
Czech Republic	Research Site	Ostrava-Vitkovice
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Prelouc
Czech Republic	Research Site	Slany
Czech Republic	Research Site	Uherske Hradiste
Czech Republic	Research Site	Valaske Klobouky
Czech Republic	Research Site	Zlin
France	Research Site	Amiens
France	Research Site	Bron
France	Research Site	Colmar Cedex
France	Research Site	Corbeil Essonnes
France	Research Site	Nantes cedex 1
France	Research Site	Paris Cedex 10
France	Research Site	Pessac
France	Research Site	Poitiers Cedex
France	Research Site	Reims Cedex
France	Research Site	Toulouse Cedex
Germany	Research Site	Aschaffenburg
Germany	Research Site	Bad Nauheim
Germany	Research Site	Bad Oeynhausen
Germany	Research Site	Berlin
Germany	Research Site	Deggingen
Germany	Research Site	Dippoldiswalde
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Germany	Research Site	Dresden
Germany	Research Site	Eschweiler
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Israel	Research Site	Ashkelon
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Mexico	Research Site	Aguascalientes
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Netherlands	Research Site	Almelo
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Puerto Rico	Research Site	Aguas Buneas
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Puerto Rico	Research Site	Jardines de Loiza, Loiza
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Puerto Rico	Research Site	San Juan
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Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
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Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	St.-Petersburg
Russian Federation	Research Site	St.Petersburg
Russian Federation	Research Site	StPetersburg
South Africa	Research Site	Benoni
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South Africa	Research Site	Johannesburg
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Spain	Research Site	Alicante
Spain	Research Site	Barcelona
Spain	Research Site	Granada
Spain	Research Site	Jerez de la Frontera Cadiz
Spain	Research Site	Lérida
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda
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Sweden	Research Site	Stockholm
Sweden	Research Site	Umeå
Taiwan	Research Site	Kaohsiung
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United Kingdom	Research Site	Aylesbury
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United States	Research Site	Albuquerque	New Mexico
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United States	Research Site	Richardson	Texas
United States	Research Site	Richmond	Virginia
United States	Research Site	Robbinsdale	Minnesota
United States	Research Site	Rochester	Michigan
United States	Research Site	Rocky Mount	North Carolina
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United States	Research Site	San Ramon	California
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United States	Research Site	Saratoga Springs	New York
United States	Research Site	Sayre	Pennsylvania
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Slidell	Louisiana
United States	Research Site	Smithfield	North Carolina
United States	Research Site	Southington	Connecticut
United States	Research Site	Southlake	Texas
United States	Research Site	Spartenburg	South Carolina
United States	Research Site	St Louis	Missouri
United States	Research Site	St Petersburg	Florida
United States	Research Site	St. Louis	Missouri
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Syracuse	New York
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Tempe	Arizona
United States	Research Site	Toledo	Ohio
United States	Research Site	Tomball	Texas
United States	Research Site	Torrance	California
United States	Research Site	Towson	Maryland
United States	Research Site	Trinity	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tyrone	Pennsylvania
United States	Research Site	Valparaiso	Indiana
United States	Research Site	Ventura	California
United States	Research Site	Victoria	Texas
United States	Research Site	Voorhees	New Jersey
United States	Research Site	Washington	District of Columbia
United States	Research Site	Waterford	Michigan
United States	Research Site	Wenatchee	Washington
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Westfield	New York
United States	Research Site	Weston	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Haven	Florida
United States	Research Site	Winter Park	Florida
United States	Research Site	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  China,  Czech Republic,  France,  Germany,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Mexico,  Netherlands,  Peru,  Poland,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Randomization (day 0) up to 2.9 years	No
Secondary	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.	Randomization (day 0) up to 2.9 years	No

External Links

•   Link
•   D1680C00003 Clinical Study Protocol
•   D1680C00003_CSR_Synopsis