Clinical trial NCT01042769: A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
Official title: A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 7226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years of age
* Type 2 diabetes mellitus
* Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)

Exclusion Criteria:

* Estimated glomerular filtration rate \<45 mL/min/1.73m2
* Concomitant treatment with a thiazolidinedione and/or fibrate
* Triglycerides \>400 mg/dL
* Anaemia
* Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

Primary outcomes:
measure: Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
timeFrame: Throughout study, approximately 4.5 years
Secondary outcomes:
measure: Effects on other cardiovascular endpoints
timeFrame: Throughout study, approximately 4.5 years
measure: Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk
timeFrame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter
measure: Tolerability and long-term safety profile
timeFrame: Throughout study, approximately 4.5 years
Other outcomes:
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city: Balatonfuered
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Kaposvár
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Pécs
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Székeshehérvár
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Kochi
country: India
state: Kerala
city: Pune
country: India
state: Maharashtra
city: Ahmedabad
country: India
city: Ahmedabad
country: India
city: Ahmedabad
country: India
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Bangalore
country: India
city: Bangalore
country: India
city: Banglore
country: India
city: Belgaum
country: India
city: Belgaum
country: India
city: Chennai
country: India
city: Cochin
country: India
city: Gurgaon
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Indore
country: India
city: Jaipur
country: India
city: Kolkata
country: India
city: Lucknow
country: India
city: Madhurai
country: India
city: Mangalore
country: India
city: Mangalore
country: India
city: Mangalore
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: Mysore
country: India
city: Nagpur
country: India
city: Nagpur
country: India
city: New Delhi
country: India
city: Palakkad
country: India
city: Pune
country: India
city: Pune
country: India
city: Pune
country: India
city: Secunderabad
country: India
city: Trivandeum
country: India
city: Ballinasloe
country: Ireland
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Galway
country: Ireland
city: Tallaght Dublin
country: Ireland
city: Napoli
country: Italy
state: Campania
city: Pozzuoli
country: Italy
state: Campania
city: Bentivoglio
country: Italy
state: Emilia-Romagna
city: Ferrara
country: Italy
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Rome
country: Italy
state: Lazio
city: Bergamo
country: Italy
state: Lombardia
city: Legnano
country: Italy
state: Lombardia
city: Mantova
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Perugia
country: Italy
state: Umbria
city: Cittadella
country: Italy
state: Veneto
city: Rovigo
country: Italy
state: Veneto
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeollabuk-do
country: Korea, Republic of
city: Kyonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Uijongbu
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
city: Kelantan
country: Malaysia
city: Kota Bharu
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuantan
country: Malaysia
city: Penang
country: Malaysia
city: Sarawak
country: Malaysia
city: Serdang
country: Malaysia
city: Acapulco
country: Mexico
city: Aguascalientes
country: Mexico
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Chihuahua
country: Mexico
city: Ciudad Juárez
country: Mexico
city: Cuernavaca
country: Mexico
city: Culiacan
country: Mexico
city: Durango
country: Mexico
city: Durango
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: Puebla
country: Mexico
city: Puerto Vallarta
country: Mexico
city: Queretaro
country: Mexico
city: San Luis Potosi S.L.P.
country: Mexico
city: Tampico
country: Mexico
city: Tijuana
country: Mexico
city: Tlalnepantla
country: Mexico
city: Veracruz
country: Mexico
city: Xalapa
country: Mexico
city: Zapopan
country: Mexico
city: AC Amsterdam
country: Netherlands
city: Amstelveen
country: Netherlands
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Hoorn
country: Netherlands
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Nijmegen
country: Netherlands
city: Purmerend
country: Netherlands
city: Tilburg
country: Netherlands
city: Weert
country: Netherlands
city: Zaandam
country: Netherlands
city: Zwolle
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Hamiton
country: New Zealand
city: Lower Hutt
country: New Zealand
city: Nelson
country: New Zealand
city: Palmerston North
country: New Zealand
city: Tauranga
country: New Zealand
city: Bialystok
country: Poland
city: Bielsko-Biala
country: Poland
city: Bydgoszcz
country: Poland
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Bêdzin
country: Poland
city: Cracow
country: Poland
city: Gdansk
country: Poland
city: Gdansk
country: Poland
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country: Poland
city: Gdynia
country: Poland
city: Gdynia
country: Poland
city: Gdynia
country: Poland
city: Gorlice
country: Poland
city: Grodzisk Mazowiecki
country: Poland
city: Katowice
country: Poland
city: Kedzierzyn-Kozle
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Kutno
country: Poland
city: Libiaz
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Nowa Sol
country: Poland
city: Nysa
country: Poland
city: Olawa
country: Poland
city: Olesnica, Spalice
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Pulawy
country: Poland
city: Radom
country: Poland
city: Rzeszow
country: Poland
city: Swidnica
country: Poland
city: Tarnow
country: Poland
city: Tarnów
country: Poland
city: Torun
country: Poland
city: Ustron
country: Poland
city: Ustroñ
country: Poland
city: Warsaw
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wola
country: Poland
city: Wroclaw
country: Poland
city: Zamosc
country: Poland
city: Zarow
country: Poland
city: Zgorzelec
country: Poland
city: £ódx
country: Poland
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Buzau
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Galati
country: Romania
city: Oradea
country: Romania
city: Ploiesti
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city: Targu-Mures
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city: Timisoara
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city: Saint-Petersburg
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city: Saint-Petersburg
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state: Alava
city: Torrevieja
country: Spain
state: Alicante
city: Oviedo
country: Spain
state: Asturias
city: Granollers
country: Spain
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: Figueres
country: Spain
state: Girona
city: Coruna
country: Spain
state: La Coruña
city: Ferrol
country: Spain
state: La Coruña
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Alcorcon
country: Spain
state: Madrid
city: San Sebastian de los Reyes
country: Spain
state: Madrid
city: Seville
country: Spain
state: Sevilla
city: Reus
country: Spain
state: Tarragona
city: Bilbao
country: Spain
state: Vizcaya
city: Alicante
country: Spain
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Guadalajara
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Murcia
country: Spain
city: Salamanca
country: Spain
city: Tarragona
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Danderyd Stockholm
country: Sweden
city: Goteborg
country: Sweden
city: Halmstad
country: Sweden
city: Kalmar
country: Sweden
city: Karlstad
country: Sweden
city: Kristianstad
country: Sweden
city: Malmö
country: Sweden
city: Ostersund
country: Sweden
city: Skellefteå
country: Sweden
city: Skovde
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Amphur Mae-Rim
country: Thailand
city: Amphur Muang
country: Thailand
city: Amphur Muang
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: ChiangMai
country: Thailand
city: Chonburi
country: Thailand
city: Khon Kaen
country: Thailand
city: Khonkaen
country: Thailand
city: Klong Luang
country: Thailand
city: Phitsanulok
country: Thailand
city: Saraburi
country: Thailand
city: Abano Terme
country: United Kingdom
city: Antrim
country: United Kingdom
city: AYR
country: United Kingdom
city: Basildon
country: United Kingdom
city: Bath
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Brighton
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Craigavon
country: United Kingdom
city: Derby
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrow
country: United Kingdom
city: Inverness
country: United Kingdom
city: Isle of Wight
country: United Kingdom
city: Isleworth
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesex
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Northampton
country: United Kingdom
city: Paddington
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Poole
country: United Kingdom
city: Romford
country: United Kingdom
city: Stoker on Trent
country: United Kingdom
city: West Bromwich
country: United Kingdom
city: Wrexham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schrieks IC, Nozza A, Stahli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Ryden L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.
citation: Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Ryden L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.
citation: Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Ryden L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.