Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (SAVOR- TIMI 53)
9. juli 2014 oppdatert av: AstraZeneca
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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Intervensjonell
Registrering (Faktiske)
18206
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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Eindhoven, Nederland
- Research Site
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Goes, Nederland
- Research Site
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Gouda, Nederland
- Research Site
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Groningen, Nederland
- Research Site
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Hardenberg, Nederland
- Research Site
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Hoogeveen, Nederland
- Research Site
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Hoorn, Nederland
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Leiderdorp, Nederland
- Research Site
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Nijmegen, Nederland
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Rotterdam, Nederland
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Sneek, Nederland
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Utrecht, Nederland
- Research Site
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Velp, Nederland
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Waalwijk, Nederland
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Zoetermeer, Nederland
- Research Site
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Callao, Peru
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Lima, Peru
- Research Site
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San Isidro, Peru
- Research Site
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Bydgoszcz, Polen
- Research Site
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Gdansk, Polen
- Research Site
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Kamieniec Ząbkowicki, Polen
- Research Site
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Koluszki, Polen
- Research Site
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Krakow, Polen
- Research Site
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Lodz, Polen
- Research Site
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Mrgowo, Polen
- Research Site
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Nakso nad Noteci, Polen
- Research Site
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Opole, Polen
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Oława, Polen
- Research Site
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Poznan, Polen
- Research Site
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Przemyśl, Polen
- Research Site
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Sieradz, Polen
- Research Site
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Skierniewice, Polen
- Research Site
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Toruń, Polen
- Research Site
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Warszawa, Polen
- Research Site
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Wroclaw, Polen
- Research Site
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Wrocław, Polen
- Research Site
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Wąbrzeźno, Polen
- Research Site
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Zabrze, Polen
- Research Site
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Łęczna, Polen
- Research Site
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Aguas Buneas, Puerto Rico
- Research Site
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Bayamon, Puerto Rico
- Research Site
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Cidra, Puerto Rico
- Research Site
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Hato Rey, Puerto Rico
- Research Site
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Jardines de Loiza, Loiza, Puerto Rico
- Research Site
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Juncos, Puerto Rico
- Research Site
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Ponce, Puerto Rico
- Research Site
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Rio Piedras, Puerto Rico
- Research Site
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San Juan, Puerto Rico
- Research Site
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Toa Baja, Puerto Rico
- Research Site
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Alicante, Spania
- Research Site
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Barcelona, Spania
- Research Site
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Granada, Spania
- Research Site
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Jerez de la Frontera Cadiz, Spania
- Research Site
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Lérida, Spania
- Research Site
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Madrid, Spania
- Research Site
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Majadahonda, Spania
- Research Site
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Oviedo, Spania
- Research Site
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Palma de Mallorca, Spania
- Research Site
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Santiago de Compostela, Spania
- Research Site
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Sevilla, Spania
- Research Site
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Valencia, Spania
- Research Site
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Aylesbury, Storbritannia
- Research Site
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Bath, Storbritannia
- Research Site
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Belfast, Storbritannia
- Research Site
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Blackpool, Storbritannia
- Research Site
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Corsham, Storbritannia
- Research Site
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Coventry, Storbritannia
- Research Site
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Fowey, Storbritannia
- Research Site
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Kenton, Storbritannia
- Research Site
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Leicester, Storbritannia
- Research Site
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Mortimer Reading, Storbritannia
- Research Site
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Plymouth, Storbritannia
- Research Site
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Sheffield, Storbritannia
- Research Site
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Sunbury on Thames, Storbritannia
- Research Site
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Swindon, Storbritannia
- Research Site
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Wansford, Storbritannia
- Research Site
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Warminster, Storbritannia
- Research Site
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Whitstable, Storbritannia
- Research Site
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Brämhult, Sverige
- Research Site
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Eksjö, Sverige
- Research Site
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Goteborg, Sverige
- Research Site
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Göteborg, Sverige
- Research Site
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Helsingborg, Sverige
- Research Site
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Jönköping, Sverige
- Research Site
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Malmo, Sverige
- Research Site
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Rättvik, Sverige
- Research Site
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Stockholm, Sverige
- Research Site
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Söråker, Sverige
- Research Site
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Umeå, Sverige
- Research Site
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Örebro, Sverige
- Research Site
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Östersund, Sverige
- Research Site
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Benoni, Sør-Afrika
- Research Site
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Cape Town, Sør-Afrika
- Research Site
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Durban, Sør-Afrika
- Research Site
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Johannesburg, Sør-Afrika
- Research Site
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Parow, Sør-Afrika
- Research Site
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Pretoria, Sør-Afrika
- Research Site
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Umkomaas, Sør-Afrika
- Research Site
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Verulam, Sør-Afrika
- Research Site
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Kaohsiung, Taiwan
- Research Site
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Kaohsiung Hsien, Taiwan
- Research Site
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Taichung, Taiwan
- Research Site
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Taipei, Taiwan
- Research Site
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Yong-Kang City, Taiwan
- Research Site
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Bangkok, Thailand
- Research Site
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Bangkoknoi, Thailand
- Research Site
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Chiang Mai, Thailand
- Research Site
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Khon Kaen, Thailand
- Research Site
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Ratchaburi, Thailand
- Research Site
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Beroun, Tsjekkisk Republikk
- Research Site
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Blansko, Tsjekkisk Republikk
- Research Site
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Breclav, Tsjekkisk Republikk
- Research Site
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Brno, Tsjekkisk Republikk
- Research Site
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Caslav, Tsjekkisk Republikk
- Research Site
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Cheb, Tsjekkisk Republikk
- Research Site
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Chrudim III, Tsjekkisk Republikk
- Research Site
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Havirov, Tsjekkisk Republikk
- Research Site
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Hodonin, Tsjekkisk Republikk
- Research Site
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Horovice, Tsjekkisk Republikk
- Research Site
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Hradec Kralove, Tsjekkisk Republikk
- Research Site
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Jablonec nad Nisou, Tsjekkisk Republikk
- Research Site
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Kromeriz, Tsjekkisk Republikk
- Research Site
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Olomouc-Lazce, Tsjekkisk Republikk
- Research Site
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Ostrava, Tsjekkisk Republikk
- Research Site
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Ostrava - Belsky les, Tsjekkisk Republikk
- Research Site
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Ostrava - Kuncice, Tsjekkisk Republikk
- Research Site
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Ostrava-Vitkovice, Tsjekkisk Republikk
- Research Site
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Pardubice, Tsjekkisk Republikk
- Research Site
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Plzen, Tsjekkisk Republikk
- Research Site
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Praha, Tsjekkisk Republikk
- Research Site
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Praha 2, Tsjekkisk Republikk
- Research Site
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Praha 6, Tsjekkisk Republikk
- Research Site
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Prelouc, Tsjekkisk Republikk
- Research Site
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Slany, Tsjekkisk Republikk
- Research Site
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Uherske Hradiste, Tsjekkisk Republikk
- Research Site
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Valaske Klobouky, Tsjekkisk Republikk
- Research Site
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Zlin, Tsjekkisk Republikk
- Research Site
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Aschaffenburg, Tyskland
- Research Site
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Bad Nauheim, Tyskland
- Research Site
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Bad Oeynhausen, Tyskland
- Research Site
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Berlin, Tyskland
- Research Site
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Deggingen, Tyskland
- Research Site
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Dippoldiswalde, Tyskland
- Research Site
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Dortmund, Tyskland
- Research Site
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Dresden, Tyskland
- Research Site
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Eschweiler, Tyskland
- Research Site
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Gießen, Tyskland
- Research Site
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Goch, Tyskland
- Research Site
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Gueglingen, Tyskland
- Research Site
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Hamburg, Tyskland
- Research Site
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Hohenmölsen, Tyskland
- Research Site
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Kassel, Tyskland
- Research Site
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Leipzig, Tyskland
- Research Site
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Mayen, Tyskland
- Research Site
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Rehlingen Siersburg, Tyskland
- Research Site
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Rotenburg, Tyskland
- Research Site
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Balatonfüred, Ungarn
- Research Site
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Budapest, Ungarn
- Research Site
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Békéscsaba, Ungarn
- Research Site
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Cegled, Ungarn
- Research Site
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Csongrad, Ungarn
- Research Site
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Eger, Ungarn
- Research Site
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Gyor, Ungarn
- Research Site
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Gyula, Ungarn
- Research Site
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Gyöngyös, Ungarn
- Research Site
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Miskolc, Ungarn
- Research Site
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Nagykanizsa, Ungarn
- Research Site
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Pecs, Ungarn
- Research Site
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Siofok, Ungarn
- Research Site
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Szolnok, Ungarn
- Research Site
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Veszprém, Ungarn
- Research Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
|
|
Eksperimentell: Saksagliptin
|
5 mg or 2.5 mg once daily
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Tidsramme: 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.
|
Randomization (day 0) up to 2.9 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: Randomization (day 0) up to 2.9 years
|
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
|
|
Participants With Event of Death
Tidsramme: Randomization (day 0) up to 2.9 years
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Eugene Braunwald, TIMI
- Hovedetterforsker: Itamar Raz, Hadassah Medical Organization
- Hovedetterforsker: Deepak Bhatt, TIMI
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030. No abstract available.
- Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.
- Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.
- Scirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjostrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.
- Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4.
- Mosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.
- Scirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.
- Cavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.
- Mosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.
- Leiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.
- Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.
- Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4. Erratum In: Circulation. 2015 Oct 13;132(15):e198.
- Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.
- Mosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.
- Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2010
Primær fullføring (Faktiske)
1. mai 2013
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
25. mars 2010
Først innsendt som oppfylte QC-kriteriene
20. april 2010
Først lagt ut (Anslag)
21. april 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. juli 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juli 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehemmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hemmere
- Saksagliptin
Andre studie-ID-numre
- D1680C00003
- EudraCT No 2009-017358-10
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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