A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6)
July 11, 2022 updated by: Novo Nordisk A/S
This trial is conducted globally.
The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3183
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Annaba, Algeria, 23000
- Novo Nordisk Investigational Site
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Oran, Algeria, 31000
- Novo Nordisk Investigational Site
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Setif, Algeria, 19000
- Novo Nordisk Investigational Site
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Tizi Ouzou, Algeria, 16015
- Novo Nordisk Investigational Site
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Buenos Aires, Argentina, B1704ETD
- Novo Nordisk Investigational Site
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Buenos Aires, Argentina, C1428ART
- Novo Nordisk Investigational Site
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Caba, Argentina, C1440AAD
- Novo Nordisk Investigational Site
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Caba, Argentina, C1120AAC
- Novo Nordisk Investigational Site
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Caba, Argentina, C1428ART
- Novo Nordisk Investigational Site
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Cordoba, Argentina, 5000
- Novo Nordisk Investigational Site
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Lanus Este, Argentina, B1824KAJ
- Novo Nordisk Investigational Site
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Parana
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Curitiba, Parana, Brazil, 80030-110
- Novo Nordisk Investigational Site
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Sao Paulo
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Mogi das Cruzes, Sao Paulo, Brazil, 08780-090
- Novo Nordisk Investigational Site
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São José dos Campos, Sao Paulo, Brazil, 12243-280
- Novo Nordisk Investigational Site
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São Paulo, Sao Paulo, Brazil, 01228-200
- Novo Nordisk Investigational Site
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Alberta
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Calgary, Alberta, Canada, T2V 4J2
- Novo Nordisk Investigational Site
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Edmonton, Alberta, Canada, T6H 2L4
- Novo Nordisk Investigational Site
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
- Novo Nordisk Investigational Site
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Brampton, Ontario, Canada, L6Z 4N5
- Novo Nordisk Investigational Site
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Concord, Ontario, Canada, L4K 4M2
- Novo Nordisk Investigational Site
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Toronto, Ontario, Canada, M5G 2C4
- Novo Nordisk Investigational Site
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Quebec
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Montreal, Quebec, Canada, H4A 3T2
- Novo Nordisk Investigational Site
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Aarhus N, Denmark, 8200
- Novo Nordisk Investigational Site
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Esbjerg, Denmark, 6700
- Novo Nordisk Investigational Site
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Hellerup, Denmark, 2900
- Novo Nordisk Investigational Site
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Hvidovre, Denmark, 2650
- Novo Nordisk Investigational Site
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Odense, Denmark, 5000
- Novo Nordisk Investigational Site
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Bochum, Germany, 44791
- Novo Nordisk Investigational Site
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Dresden, Germany, 01307
- Novo Nordisk Investigational Site
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Elsterwerda, Germany, 04910
- Novo Nordisk Investigational Site
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Essen, Germany, 45219
- Novo Nordisk Investigational Site
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Falkensee, Germany, 14612
- Novo Nordisk Investigational Site
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Hamburg, Germany, 22607
- Novo Nordisk Investigational Site
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Ludwigshafen, Germany, 67059
- Novo Nordisk Investigational Site
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Münster, Germany, 48145
- Novo Nordisk Investigational Site
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Oldenburg, Germany, 23758
- Novo Nordisk Investigational Site
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Oldenburg I. Holst, Germany, 23758
- Novo Nordisk Investigational Site
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Rehlingen-Siersburg, Germany, 66780
- Novo Nordisk Investigational Site
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Saint Ingbert-Oberwürzbach, Germany, 66386
- Novo Nordisk Investigational Site
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New Delhi, India, 110001
- Novo Nordisk Investigational Site
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New Delhi, India, 110017
- Novo Nordisk Investigational Site
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Pune, India, 411011
- Novo Nordisk Investigational Site
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500034
- Novo Nordisk Investigational Site
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Hyderbad, Andhra Pradesh, India, 500 012
- Novo Nordisk Investigational Site
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Gujarat
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Ahmedabad, Gujarat, India, 380006
- Novo Nordisk Investigational Site
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Ahmedabad, Gujarat, India, 380052
- Novo Nordisk Investigational Site
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Kerala
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Kochi, Kerala, India, 682041
- Novo Nordisk Investigational Site
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Kozhikode, Kerala, India, 673017
- Novo Nordisk Investigational Site
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Thiruvananthapuram, Kerala, India, 695031
- Novo Nordisk Investigational Site
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Maharashtra
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Goa, Maharashtra, India, 403 202
- Novo Nordisk Investigational Site
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Mumbai, Maharashtra, India, 400008
- Novo Nordisk Investigational Site
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Mumbai, Maharashtra, India, 400012
- Novo Nordisk Investigational Site
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Pune, Maharashtra, India, 411001
- Novo Nordisk Investigational Site
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Pune, Maharashtra, India, 411004
- Novo Nordisk Investigational Site
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New Delhi
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New Dehli, New Delhi, India, 110029
- Novo Nordisk Investigational Site
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Punjab
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Ludhiana, Punjab, India, 141008
- Novo Nordisk Investigational Site
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600086
- Novo Nordisk Investigational Site
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West Bengal
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Kolkata, West Bengal, India, 700054
- Novo Nordisk Investigational Site
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Haifa, Israel, 35152
- Novo Nordisk Investigational Site
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Holon, Israel, 58100
- Novo Nordisk Investigational Site
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Jerusalem, Israel, 91120
- Novo Nordisk Investigational Site
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Nahariya, Israel, 22100
- Novo Nordisk Investigational Site
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Petah-Tikva, Israel, 49100
- Novo Nordisk Investigational Site
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Rishon Le Zion, Israel, 75650
- Novo Nordisk Investigational Site
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Tel Aviv, Israel, 6937947
- Novo Nordisk Investigational Site
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Tel-Aviv, Israel, 64239
- Novo Nordisk Investigational Site
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Bergamo, Italy, 24127
- Novo Nordisk Investigational Site
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Catanzaro, Italy, 88100
- Novo Nordisk Investigational Site
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Chieti, Italy, 66100
- Novo Nordisk Investigational Site
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Milano, Italy, 20132
- Novo Nordisk Investigational Site
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Palermo, Italy, 90127
- Novo Nordisk Investigational Site
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Roma, Italy, 00161
- Novo Nordisk Investigational Site
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Roma, Italy, 00133
- Novo Nordisk Investigational Site
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Ipoh, Perak, Malaysia, 30990
- Novo Nordisk Investigational Site
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Kota Bharu, Malaysia, 15586
- Novo Nordisk Investigational Site
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Kota Bharu, Kelantan, Malaysia, 16150
- Novo Nordisk Investigational Site
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Kota Samarahan, Malaysia, 94300
- Novo Nordisk Investigational Site
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Kuala Lumpur, Malaysia, 59100
- Novo Nordisk Investigational Site
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Kuala Lumpur, Malaysia, 50400
- Novo Nordisk Investigational Site
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Kuching, Malaysia, 93586
- Novo Nordisk Investigational Site
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Melaka, Malaysia, 75400
- Novo Nordisk Investigational Site
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Putrajaya, Malaysia, 62250
- Novo Nordisk Investigational Site
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Seremban, Malaysia, 70300
- Novo Nordisk Investigational Site
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San Luis Potosi, Mexico, 78200
- Novo Nordisk Investigational Site
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Jalisco
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Guadalajara, Jalisco, Mexico, 44600
- Novo Nordisk Investigational Site
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Guadalajara, Jalisco, Mexico, 44650
- Novo Nordisk Investigational Site
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Guadalajara, Jalisco, Mexico, 44670
- Novo Nordisk Investigational Site
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Novo Nordisk Investigational Site
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Yucatan
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Merida, Yucatan, Mexico, 97070
- Novo Nordisk Investigational Site
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Almere, Netherlands, 1311RL
- Novo Nordisk Investigational Site
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Amsterdam, Netherlands, 1066 EC
- Novo Nordisk Investigational Site
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Eindhoven, Netherlands, 5631 BM
- Novo Nordisk Investigational Site
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Hoogeveen, Netherlands, 7909 AA
- Novo Nordisk Investigational Site
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Nijmegen, Netherlands, 6525 GA
- Novo Nordisk Investigational Site
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Krakow, Poland, 31-271
- Novo Nordisk Investigational Site
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Krakow, Poland, 31-261
- Novo Nordisk Investigational Site
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Lublin, Poland, 20-044
- Novo Nordisk Investigational Site
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Poznan, Poland, 60-589
- Novo Nordisk Investigational Site
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Warszawa, Poland, 01-192
- Novo Nordisk Investigational Site
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Bucharest, Romania, 020475
- Novo Nordisk Investigational Site
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Bucharest, Romania, 010507
- Novo Nordisk Investigational Site
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Bucharest, Romania, 020359
- Novo Nordisk Investigational Site
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Bucharest, Romania, 010627
- Novo Nordisk Investigational Site
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Bucharest, Romania
- Novo Nordisk Investigational Site
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Galati, Romania, 800098
- Novo Nordisk Investigational Site
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Bihor
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Oradea, Bihor, Romania, 410025
- Novo Nordisk Investigational Site
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Mures
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Targu Mures, Mures, Romania, 540142
- Novo Nordisk Investigational Site
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Tirgu Mures, Mures, Romania, 540142
- Novo Nordisk Investigational Site
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Free State
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Bloemfontein, Free State, South Africa, 9301
- Novo Nordisk Investigational Site
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Gauteng
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Johannesburg, Gauteng, South Africa, 1827
- Novo Nordisk Investigational Site
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Johannesburg, Gauteng, South Africa, 2013
- Novo Nordisk Investigational Site
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Lenasia, Gauteng, South Africa, 1827
- Novo Nordisk Investigational Site
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Pretoria, Gauteng, South Africa, 0181
- Novo Nordisk Investigational Site
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KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa, 4001
- Novo Nordisk Investigational Site
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Durban, KwaZulu-Natal, South Africa, 4450
- Novo Nordisk Investigational Site
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Mpumalanga
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Middleburg, Mpumalanga, South Africa, 1055
- Novo Nordisk Investigational Site
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Western Cape
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Cape Town, Western Cape, South Africa, 7925
- Novo Nordisk Investigational Site
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Alcala de Henares, Spain, 28805
- Novo Nordisk Investigational Site
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Badalona, Spain, 08916
- Novo Nordisk Investigational Site
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Fuenlabrada - Madrid, Spain, 28942
- Novo Nordisk Investigational Site
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Madrid, Spain, 28046
- Novo Nordisk Investigational Site
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Málaga, Spain, 29006
- Novo Nordisk Investigational Site
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Palma de Mallorca, Spain, 07198
- Novo Nordisk Investigational Site
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Pontevedra, Spain, 36071
- Novo Nordisk Investigational Site
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Sevilla, Spain, 41010
- Novo Nordisk Investigational Site
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Sevilla, Spain, 41003
- Novo Nordisk Investigational Site
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Valencia, Spain, 46026
- Novo Nordisk Investigational Site
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Valencia, Spain, 46014
- Novo Nordisk Investigational Site
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Kaohsiung City, Taiwan, 833
- Novo Nordisk Investigational Site
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Taichung City, Taiwan, 407
- Novo Nordisk Investigational Site
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Tainan city, Taiwan, 710
- Novo Nordisk Investigational Site
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Taipei, Taiwan, 100
- Novo Nordisk Investigational Site
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Bangkok, Thailand, 10400
- Novo Nordisk Investigational Site
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Bangkok, Thailand, 10330
- Novo Nordisk Investigational Site
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Bangkok, Thailand, 10700
- Novo Nordisk Investigational Site
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Chiang Mai, Thailand, 50200
- Novo Nordisk Investigational Site
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Klong Luang, Pathumthani, Thailand, 12120
- Novo Nordisk Investigational Site
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Nakhon Ratchasima, Thailand, 30000
- Novo Nordisk Investigational Site
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Ankara, Turkey, 06100
- Novo Nordisk Investigational Site
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Ankara, Turkey, 06500
- Novo Nordisk Investigational Site
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Antalya, Turkey, 07058
- Novo Nordisk Investigational Site
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Aydin, Turkey, 09010
- Novo Nordisk Investigational Site
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Denizli, Turkey, 20070
- Novo Nordisk Investigational Site
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Gaziantep, Turkey, 27070
- Novo Nordisk Investigational Site
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Istanbul, Turkey, 34371
- Novo Nordisk Investigational Site
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Istanbul, Turkey, 34760
- Novo Nordisk Investigational Site
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Izmir, Turkey, 35100
- Novo Nordisk Investigational Site
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Izmir, Turkey, 35340
- Novo Nordisk Investigational Site
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Rize, Turkey, 53020
- Novo Nordisk Investigational Site
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Aberdeen, United Kingdom, AB25 2ZD
- Novo Nordisk Investigational Site
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Bristol, United Kingdom, BS10 5NB
- Novo Nordisk Investigational Site
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Dundee, United Kingdom, DD1 9SY
- Novo Nordisk Investigational Site
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Edinburgh, United Kingdom, EH4 2XU
- Novo Nordisk Investigational Site
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Exeter, United Kingdom, EX2 5DW
- Novo Nordisk Investigational Site
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Guildford, United Kingdom, GU2 7XX
- Novo Nordisk Investigational Site
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Norfolk, United Kingdom, NR4 7UQ
- Novo Nordisk Investigational Site
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Swansea, United Kingdom, SA2 8PP
- Novo Nordisk Investigational Site
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Watford, United Kingdom, WD18 0HB
- Novo Nordisk Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Novo Nordisk Investigational Site
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Searcy, Arkansas, United States, 72143
- Novo Nordisk Investigational Site
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California
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Concord, California, United States, 94520
- Novo Nordisk Investigational Site
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Huntington Beach, California, United States, 92648
- Novo Nordisk Investigational Site
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La Jolla, California, United States, 92037
- Novo Nordisk Investigational Site
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La Mesa, California, United States, 91942
- Novo Nordisk Investigational Site
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Lancaster, California, United States, 93534
- Novo Nordisk Investigational Site
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Monterey, California, United States, 93940
- Novo Nordisk Investigational Site
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San Diego, California, United States, 92111
- Novo Nordisk Investigational Site
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San Ramon, California, United States, 94583
- Novo Nordisk Investigational Site
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Ventura, California, United States, 93003
- Novo Nordisk Investigational Site
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Florida
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Boca Raton, Florida, United States, 33433
- Novo Nordisk Investigational Site
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New Port Richey, Florida, United States, 34652
- Novo Nordisk Investigational Site
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Georgia
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Roswell, Georgia, United States, 30076
- Novo Nordisk Investigational Site
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Savannah, Georgia, United States, 31406
- Novo Nordisk Investigational Site
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Hawaii
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Honolulu, Hawaii, United States, 96814
- Novo Nordisk Investigational Site
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Illinois
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Springfield, Illinois, United States, 62702
- Novo Nordisk Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46254
- Novo Nordisk Investigational Site
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Michigan City, Indiana, United States, 46360
- Novo Nordisk Investigational Site
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Muncie, Indiana, United States, 47304
- Novo Nordisk Investigational Site
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Iowa
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Council Bluffs, Iowa, United States, 51501
- Novo Nordisk Investigational Site
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Kentucky
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Lexington, Kentucky, United States, 40503
- Novo Nordisk Investigational Site
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Lexington, Kentucky, United States, 40502
- Novo Nordisk Investigational Site
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Louisville, Kentucky, United States, 40213
- Novo Nordisk Investigational Site
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Louisiana
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Monroe, Louisiana, United States, 71203
- Novo Nordisk Investigational Site
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Slidell, Louisiana, United States, 70461-4231
- Novo Nordisk Investigational Site
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Michigan
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Canton, Michigan, United States, 48187
- Novo Nordisk Investigational Site
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Troy, Michigan, United States, 48098
- Novo Nordisk Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68114
- Novo Nordisk Investigational Site
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Omaha, Nebraska, United States, 68198
- Novo Nordisk Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89128
- Novo Nordisk Investigational Site
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New Hampshire
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Nashua, New Hampshire, United States, 03063
- Novo Nordisk Investigational Site
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New York
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Albany, New York, United States, 12206
- Novo Nordisk Investigational Site
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Albany, New York, United States, 12203
- Novo Nordisk Investigational Site
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North Massapequa, New York, United States, 11758-1802
- Novo Nordisk Investigational Site
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Westfield, New York, United States, 14787
- Novo Nordisk Investigational Site
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North Carolina
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Asheville, North Carolina, United States, 28803
- Novo Nordisk Investigational Site
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Greenville, North Carolina, United States, 27834
- Novo Nordisk Investigational Site
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Wilmington, North Carolina, United States, 28401
- Novo Nordisk Investigational Site
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North Dakota
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Fargo, North Dakota, United States, 58104
- Novo Nordisk Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Novo Nordisk Investigational Site
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Columbus, Ohio, United States, 43203
- Novo Nordisk Investigational Site
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Maumee, Ohio, United States, 43537
- Novo Nordisk Investigational Site
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Pennsylvania
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Beaver, Pennsylvania, United States, 15009
- Novo Nordisk Investigational Site
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Philadelphia, Pennsylvania, United States, 19114
- Novo Nordisk Investigational Site
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South Carolina
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Anderson, South Carolina, United States, 29621
- Novo Nordisk Investigational Site
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Moncks Corner, South Carolina, United States, 29461
- Novo Nordisk Investigational Site
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Myrtle Beach, South Carolina, United States, 29572
- Novo Nordisk Investigational Site
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Spartanburg, South Carolina, United States, 29303
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Novo Nordisk Investigational Site
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Chattanooga, Tennessee, United States, 37411
- Novo Nordisk Investigational Site
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Kingsport, Tennessee, United States, 37660
- Novo Nordisk Investigational Site
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Knoxville, Tennessee, United States, 37938
- Novo Nordisk Investigational Site
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Nashville, Tennessee, United States, 37212
- Novo Nordisk Investigational Site
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Nashville, Tennessee, United States, 37203
- Novo Nordisk Investigational Site
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Texas
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Arlington, Texas, United States, 76012-4637
- Novo Nordisk Investigational Site
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Austin, Texas, United States, 78731
- Novo Nordisk Investigational Site
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Austin, Texas, United States, 78749
- Novo Nordisk Investigational Site
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Austin, Texas, United States, 78705
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75230
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75390-9302
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75231
- Novo Nordisk Investigational Site
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Hurst, Texas, United States, 76054
- Novo Nordisk Investigational Site
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Midland, Texas, United States, 79707
- Novo Nordisk Investigational Site
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Round Rock, Texas, United States, 78681
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78228-6205
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78220
- Novo Nordisk Investigational Site
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Waco, Texas, United States, 76710
- Novo Nordisk Investigational Site
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Vermont
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South Burlington, Vermont, United States, 05403
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Virginia
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Norfolk, Virginia, United States, 23510-2015
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Winchester, Virginia, United States, 22601-3834
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female diagnosed with type 2 diabetes
- Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor
Exclusion Criteria:
- Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
- Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
- History of pancreatitis (acute or chronic)
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
- Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m^2)
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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For oral use once daily.
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EXPERIMENTAL: Oral semaglutide
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For oral use once daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke
Time Frame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure
Time Frame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Participants experiencing first occurrence of an expanded composite CV endpoint [defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, UAP (unstable angina pectoris) requiring hospitalisation or heart failure requiring hospitalisation] are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint
Time Frame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Participants experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or heart failure requiring hospitalisation) are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke
Time Frame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Participants experiencing first occurrence of a composite CV endpoint (defined as all-cause death, non-fatal myocardial infarction or nonfatal stroke) are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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|
Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction
Time Frame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
|
Number of participants experiencing a first event of a fatal or non-fatal myocardial infarction are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke
Time Frame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
|
Number of participants experiencing a first event of a fatal or non-fatal stroke are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
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Time From Randomisation to All-cause Death
Time Frame: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.
|
Number of all-cause deaths in the study are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.
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Time to First AE Leading to Permanent Trial Product Discontinuation
Time Frame: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.
|
Number of participants who permanently discontinued trial product in ths study are presented.
Results are based on the on-treatment observation period which starts at the date of first dose on trial product; ends on last date on trial product +38 days (ascertainment window).
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Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.
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Number of Serious Adverse Events
Time Frame: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.
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Number of serious adverse events were recorded from week 0 to week 87 in the study.
Results are based on the on-treatment observation period which started at the date of first dose on trial product and ended on last date on trial product +38 days (ascertainment window).
|
Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.
|
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Change in Eye Examination Category
Time Frame: Week -3, End of treatment
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Participants with eye examination findings, normal, abnormal non clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -3) and end of treatment visit (week 83) are presented.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Week -3, End of treatment
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Change in Pulse Rate
Time Frame: Week 0, End of treatment
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Change from baseline (week 0) in pulse rate measured at the end of treatment visit (week 83) is reported.
Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).
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Week 0, End of treatment
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Change in Systolic and Diastolic Blood Pressure
Time Frame: Week 0, End of treatment
|
Change from baseline (week 0) in systolic and diastolic blood pressure measured at the end of treatment visit (week 83) is reported.
Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).
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Week 0, End of treatment
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Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, End of treatment
|
Change from baseline (week 0) in HbA1c measured at the end of treatment visit (week 83) is reported.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
|
Week 0, End of treatment
|
|
Change in Body Weight
Time Frame: Week 0, End of treatment
|
Change from baseline (week 0) in body weight measured at the end of treatment visit (week 83) is reported.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Week 0, End of treatment
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Change in Total Cholesterol - Ratio to Baseline
Time Frame: Week 0, End of treatment
|
Change from baseline (week 0) in total cholesterol (mmol/L) at the end of treatment (week 83) visit is presented as ratio to baseline.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
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Week 0, End of treatment
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|
Change in LDL-cholesterol - Ratio to Baseline
Time Frame: Week 0, End of treatment
|
Change from baseline (week 0) in LDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
|
Week 0, End of treatment
|
|
Change in HDL-cholesterol - Ratio to Baseline
Time Frame: Week 0, End of treatment
|
Change from baseline (week 0) in HDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
|
Week 0, End of treatment
|
|
Change in Triglycerides - Ratio to Baseline
Time Frame: Week 0, End of treatment
|
Change from baseline (week 0) in triglycerides (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline.
Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
|
Week 0, End of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cefalu WT, Kaul S, Gerstein HC, Holman RR, Zinman B, Skyler JS, Green JB, Buse JB, Inzucchi SE, Leiter LA, Raz I, Rosenstock J, Riddle MC. Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum. Diabetes Care. 2018 Jan;41(1):14-31. doi: 10.2337/dci17-0057.
- Bain SC, Mosenzon O, Arechavaleta R, Bogdanski P, Comlekci A, Consoli A, Deerochanawong C, Dungan K, Faingold MC, Farkouh ME, Franco DR, Gram J, Guja C, Joshi P, Malek R, Merino-Torres JF, Nauck MA, Pedersen SD, Sheu WH, Silver RJ, Tack CJ, Tandon N, Jeppesen OK, Strange M, Thomsen M, Husain M. Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial. Diabetes Obes Metab. 2019 Mar;21(3):499-508. doi: 10.1111/dom.13553. Epub 2018 Nov 11.
- Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, Jeppesen OK, Lingvay I, Mosenzon O, Pedersen SD, Tack CJ, Thomsen M, Vilsboll T, Warren ML, Bain SC; PIONEER 6 Investigators. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2019 Aug 29;381(9):841-851. doi: 10.1056/NEJMoa1901118. Epub 2019 Jun 11.
- Evans LM, Mellbin L, Johansen P, Lawson J, Paine A, Sandberg A. A population-adjusted indirect comparison of cardiovascular benefits of once-weekly subcutaneous semaglutide and dulaglutide in the treatment of patients with type 2 diabetes, with or without established cardiovascular disease. Endocrinol Diabetes Metab. 2021 May 15;4(3):e00259. doi: 10.1002/edm2.259. eCollection 2021 Jul.
- Husain M, Consoli A, De Remigis A, Pettersson Meyer AS, Rasmussen S, Bain S. Semaglutide reduces cardiovascular events regardless of metformin use: a post hoc subgroup analysis of SUSTAIN 6 and PIONEER 6. Cardiovasc Diabetol. 2022 Apr 28;21(1):64. doi: 10.1186/s12933-022-01489-6.
- Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9.
- Strain WD, Frenkel O, James MA, Leiter LA, Rasmussen S, Rothwell PM, Sejersten Ripa M, Truelsen TC, Husain M. Effects of Semaglutide on Stroke Subtypes in Type 2 Diabetes: Post Hoc Analysis of the Randomized SUSTAIN 6 and PIONEER 6. Stroke. 2022 Sep;53(9):2749-2757. doi: 10.1161/STROKEAHA.121.037775. Epub 2022 May 18.
- Verma S, Fainberg U, Husain M, Rasmussen S, Ryden L, Ripa MS, Buse JB. Applying REWIND cardiovascular disease criteria to SUSTAIN 6 and PIONEER 6: An exploratory analysis of cardiovascular outcomes with semaglutide. Diabetes Obes Metab. 2021 Jul;23(7):1677-1680. doi: 10.1111/dom.14360. Epub 2021 Mar 18.
- Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
- Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.
- Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 17, 2017
Primary Completion (ACTUAL)
September 25, 2018
Study Completion (ACTUAL)
September 25, 2018
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
February 23, 2016
First Posted (ESTIMATE)
February 26, 2016
Study Record Updates
Last Update Posted (ACTUAL)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 11, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9924-4221
- 2015-003563-10 (EUDRACT_NUMBER)
- U1111-1173-0750 (OTHER: WHO)
- NL56580.091.16 (OTHER: CCMO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.