Clinical trial NCT01107886: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-04-21
Enrollment: 18206
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
timeFrame: Randomization (day 0) up to 2.9 years
Secondary outcomes:
measure: 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
timeFrame: Randomization (day 0) up to 2.9 years
measure: Participants With Event of Death
timeFrame: Randomization (day 0) up to 2.9 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
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city: Tempe
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city: Berlin
country: Germany
facility: Research Site
city: Deggingen
country: Germany
facility: Research Site
city: Dippoldiswalde
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Eschweiler
country: Germany
facility: Research Site
city: Gießen
country: Germany
facility: Research Site
city: Goch
country: Germany
facility: Research Site
city: Gueglingen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hohenmölsen
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Mayen
country: Germany
facility: Research Site
city: Rehlingen Siersburg
country: Germany
facility: Research Site
city: Rotenburg
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
state: Shatin
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Balatonfüred
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Békéscsaba
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Csongrad
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Gyöngyös
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nagykanizsa
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Siofok
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Veszprém
country: Hungary
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Bengaluru
country: India
facility: Research Site
city: Ernakulam District
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Indore
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Mysore
country: India
facility: Research Site
city: Nagpur
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Vadodara
country: India
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Beer Sheva
country: Israel
facility: Research Site
city: Dimona
country: Israel
facility: Research Site
city: Givatayim
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Holon
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar-Saba
country: Israel
facility: Research Site
city: Nahariya
country: Israel
facility: Research Site
city: Petach Tikva
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel-Aviv
country: Israel
facility: Research Site
city: Zefat
country: Israel
facility: Research Site
city: Zerifin
country: Israel
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Mercato San Severino
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Negrar - VR
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pozzuoli
country: Italy
facility: Research Site
city: Prato
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: S Maria Capua Vetere
country: Italy
facility: Research Site
city: San Giovanni Rotondo
country: Italy
facility: Research Site
city: Sessa Aurunca
country: Italy
facility: Research Site
city: Taormina
country: Italy
facility: Research Site
city: Terni
country: Italy
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Culiacan
country: Mexico
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Monclova
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: México
country: Mexico
facility: Research Site
city: Nuevo Leon
country: Mexico
facility: Research Site
city: Oaxaca
country: Mexico
facility: Research Site
city: Queretaro
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: San Luis Potosí
country: Mexico
facility: Research Site
city: Tijuana
country: Mexico
facility: Research Site
city: Xalapa
country: Mexico
facility: Research Site
city: Almelo
country: Netherlands
facility: Research Site
city: Amersfoort
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Apeldoorn
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Delft
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Goes
country: Netherlands
facility: Research Site
city: Gouda
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Hardenberg
country: Netherlands
facility: Research Site
city: Hoogeveen
country: Netherlands
facility: Research Site
city: Hoorn
country: Netherlands
facility: Research Site
city: Leiderdorp
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Sneek
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Velp
country: Netherlands
facility: Research Site
city: Waalwijk
country: Netherlands
facility: Research Site
city: Zoetermeer
country: Netherlands
facility: Research Site
city: Callao
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: San Isidro
country: Peru
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Kamieniec Ząbkowicki
country: Poland
facility: Research Site
city: Koluszki
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Mrgowo
country: Poland
facility: Research Site
city: Nakso nad Noteci
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Oława
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Przemyśl
country: Poland
facility: Research Site
city: Sieradz
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Wąbrzeźno
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Łęczna
country: Poland
facility: Research Site
city: Aguas Buneas
country: Puerto Rico
facility: Research Site
city: Bayamon
country: Puerto Rico
facility: Research Site
city: Cidra
country: Puerto Rico
facility: Research Site
city: Hato Rey
country: Puerto Rico
facility: Research Site
city: Jardines de Loiza, Loiza
country: Puerto Rico
facility: Research Site
city: Juncos
country: Puerto Rico
facility: Research Site
city: Ponce
country: Puerto Rico
facility: Research Site
city: Rio Piedras
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Toa Baja
country: Puerto Rico
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St.-Petersburg
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: StPetersburg
country: Russian Federation
facility: Research Site
city: Benoni
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Parow
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Umkomaas
country: South Africa
facility: Research Site
city: Verulam
country: South Africa
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Jerez de la Frontera Cadiz
country: Spain
facility: Research Site
city: Lérida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Brämhult
country: Sweden
facility: Research Site
city: Eksjö
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Jönköping
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Rättvik
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Söråker
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Östersund
country: Sweden
facility: Research Site
city: Kaohsiung Hsien
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Yong-Kang City
country: Taiwan
facility: Research Site
city: Bangkoknoi
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Ratchaburi
country: Thailand
facility: Research Site
city: Aylesbury
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Corsham
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Fowey
country: United Kingdom
facility: Research Site
city: Kenton
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Mortimer Reading
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Sunbury on Thames
country: United Kingdom
facility: Research Site
city: Swindon
country: United Kingdom
facility: Research Site
city: Wansford
country: United Kingdom
facility: Research Site
city: Warminster
country: United Kingdom
facility: Research Site
city: Whitstable
country: United Kingdom
facility: Research Site
Study officials:
affiliation: TIMI
name: Eugene Braunwald
role: STUDY_CHAIR
affiliation: Hadassah Medical Organization
name: Itamar Raz
role: PRINCIPAL_INVESTIGATOR
affiliation: TIMI
name: Deepak Bhatt
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.