A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes (SUSTAIN 11)

November 10, 2022 updated by: Novo Nordisk A/S

Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2274

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

Bosnia and Herzegovina
- - Banja Luka, Bosnia and Herzegovina, 78000
    - Novo Nordisk Investigational Site
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Novo Nordisk Investigational Site
  - Tuzla, Bosnia and Herzegovina, 75000
    - Novo Nordisk Investigational Site
Bulgaria
- - Burgas, Bulgaria, 8000
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  - Byala, Bulgaria, 7100
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  - Dimitrovgrad, Bulgaria, 6400
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  - Plovdiv, Bulgaria, 4002
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  - Ruse, Bulgaria, 7000
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  - Sofia, Bulgaria, 1632
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  - Stara Zagora, Bulgaria, 6000
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  - Stara Zagora, Bulgaria, 6001
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  - Varna, Bulgaria, 9010
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Croatia
- - Karlovac, Croatia, 47000
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  - Osijek, Croatia, 31 000
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  - Pula, Croatia, 52100
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  - Rijeka, Croatia, 51 000
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  - Varazdin, Croatia, 42 000
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  - Zagreb, Croatia, 10 000
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Czechia
- - Beroun, Czechia, 26601
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  - Brno, Czechia, 602 00
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  - Kladno - Krocehlavy, Czechia, 272 01
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  - Mlada Boleslav, Czechia, 293 50
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  - Nachod, Czechia, 54701
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  - Olomouc, Czechia, 77900
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  - Plzeň, Czechia, 301 00
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  - Prostejov, Czechia, 79601
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Estonia
- - Pärnu, Estonia, 80018
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  - Tallinn, Estonia, 13419
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  - Tallinn, Estonia, 10138
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  - Tallinn, Estonia, 10617
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  - Viljandi, Estonia, 71024
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Germany
- - Bad Kreuznach, Germany, 55545
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  - Bad Mergentheim, Germany, 97980
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  - Berlin, Germany, 13597
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  - Berlin, Germany, 10787
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  - Berlin, Germany, 10629
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  - Berlin, Germany, 10437
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  - Eisenach, Germany, 99817
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  - Essen, Germany, 45136
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  - Essen, Germany, 45359
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  - Essen, Germany, 45355
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  - Esslingen, Germany, 73728
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  - Falkensee, Germany, 14612
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  - Friedrichsthal, Germany, 66299
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  - Hamburg, Germany, 22607
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  - Hamburg, Germany, 22041
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  - Hohenmölsen, Germany, 06679
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  - Jerichow, Germany, 39319
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  - Kiel Kronshagen, Germany, 24119
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  - Leipzig, Germany, 04249
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  - Münster, Germany, 48145
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  - Münster, Germany, 48153
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  - Oldenburg I. Holst, Germany, 23758
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  - Pohlheim, Germany, 35415
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  - Rehlingen-Siersburg, Germany, 66780
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  - Saint Ingbert-Oberwürzbach, Germany, 66386
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  - Schwabenheim, Germany, 55270
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  - Schweinfurt, Germany, 97421
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  - Stuhr, Germany, 28816
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  - Stuttgart, Germany, 70378
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  - Stuttgart, Germany, 70199
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  - Villingen-Schwenningen, Germany, 78048
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Greece
- - Alexandroupolis, Greece, GR-68100
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  - Athens, Greece, GR-11527
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  - Athens, Greece, 115 25
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  - Athens, Greece, GR-115 27
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  - Athens, Greece, GR-11526
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  - Athens, Greece, 115 21
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  - Athens, Greece, 11522
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  - Athens, Greece, GR-11521
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  - Larissa, Greece, GR-41110
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  - Piraeus, Greece, GR-18536
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  - Thessaloniki, Greece, GR-57010
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  - Thessaloniki, Greece, GR-57001
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  - Thessaloniki, Greece, GR-54642
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  - Thessaloniki, Greece, GR-54643
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Hungary
- - Budapest, Hungary, 1042
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  - Budapest, Hungary, 1089
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  - Budapest, Hungary, 1033
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  - Gyula, Hungary, 5700
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  - Nagykanizsa, Hungary, 8800
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  - Pécs, Hungary, 7623
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  - Salgótarján, Hungary, 3100
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  - Szeged, Hungary, H-6725
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  - Zalaegerszeg, Hungary, 8900
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India
- - New Delhi, India, 110001
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- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500072
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- Gujarat
  - Ahmedabad, Gujarat, India
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- Karnataka
  - Bangalore, Karnataka, India, 560034
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  - Bangalore, Karnataka, India, 560092
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- Madhya Pradesh
  - Indore, Madhya Pradesh, India, 452010
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- Maharashtra
  - Mumbai, Maharashtra, India, 400012
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  - Mumbai, Maharashtra, India, 400058
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  - Nagpur, Maharashtra, India, 440010
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  - Pune, Maharashtra, India, 411040
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- New Delhi
  - Delhi, New Delhi, India, 110002
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  - New Dehli, New Delhi, India, 110029
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- Orissa
  - Bhubaneswar, Orissa, India, 751019
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  - Bhubaneswar, Orissa, India, 751005
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- Punjab
  - Chandigarh, Punjab, India, 160012
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  - Ludhiana, Punjab, India, 141001
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  - Mohali, Punjab, India, 160062
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- Rajasthan
  - Jaipur, Rajasthan, India, 302006
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- Tamil Nadu
  - Madurai, Tamil Nadu, India, 625 020
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- Telengana
  - Hyderabad, Telengana, India, 500003
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  - Hyderbad, Telengana, India, 500 012
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- West Bengal
  - Kolkata, West Bengal, India, 700054
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Latvia
- - Jelgava, Latvia, LV-3001
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  - Ogre, Latvia, LV-5001
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  - Riga, Latvia, LV-1002
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  - Riga, Latvia, LV-1024
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  - Sigulda, Latvia, LV-2150
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  - Talsi, Latvia, LV-3201
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Lithuania
- - Kaunas, Lithuania, 49449
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  - Kaunas, Lithuania, 48259
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  - Kaunas, Lithuania, 50009
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  - Panevezys, Lithuania, 37355
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  - Vilnius, Lithuania, 04318
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  - Vilnius, Lithuania, 08661
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North Macedonia
- - Skopje, North Macedonia, 1000
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Poland
- - Bialystok, Poland, 15-351
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  - Bialystok, Poland, 15-276
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  - Bialystok, Poland, 15-704
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  - Gorzow Wielkopolski, Poland, 66-400
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  - Lodz, Poland, 94-074 LODZ
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  - Lublin, Poland, 20-044
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  - Lublin, Poland, 20-538
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  - Lublin, Poland, 20-090
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  - Poznan, Poland, 60-589
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  - Poznan, Poland, 61-251
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  - Poznan, Poland, 61-853
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  - Pulawy, Poland, 24-100
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  - Ruda Slaska, Poland, 41-709
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  - Siedlce, Poland, 08-110
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  - Skorzewo, Poland, 60-185
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  - Warsaw, Poland, 00-465
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  - Wierzchoslawice, Poland, 33-122
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  - Wroclaw, Poland, 50-127
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  - Wroclaw, Poland, 51-685
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  - Zabrze, Poland, 41-800
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Portugal
- - Almada, Portugal, 2805-267
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  - Braga, Portugal, 4710-243
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  - Coimbra, Portugal, 3000-561
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  - Lisboa, Portugal, 1250-230
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  - Loures, Portugal, 2674-514
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  - Porto, Portugal, 4200-319
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  - Setubal, Portugal, 2910-446
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Romania
- - Brasov, Romania, 500101
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  - Brasov, Romania, 500283
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  - Galati, Romania, 800578
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- Cluj
  - Cluj Napoca, Cluj, Romania, 400006
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- Dambovita
  - Targoviste, Dambovita, Romania, 130086
    - Novo Nordisk Investigational Site
- Mures
  - Targu Mures, Mures, Romania, 540098
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- Prahova
  - Ploiesti, Prahova, Romania, 100018
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Serbia
- - Belgrade, Serbia, 11000
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  - Belgrade, Serbia, 11080
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  - Kragujevac, Serbia, 34000
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  - Nis, Serbia, 18000
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  - Novi Sad, Serbia, 21000
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  - Zajecar, Serbia, 19000
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Slovakia
- - Bardejov, Slovakia, 08501
    - Novo Nordisk Investigational Site
  - Bratislava, Slovakia, 81108
    - Novo Nordisk Investigational Site
  - Bratislava, Slovakia, 811 08
    - Novo Nordisk Investigational Site
  - Bratislava, Slovakia, 82606
    - Novo Nordisk Investigational Site
  - Dolny Kubin, Slovakia, 02601
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  - Levice, Slovakia, 93401
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  - Lubochna, Slovakia, 03491
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  - Martin, Slovakia, 03601
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  - Presov, Slovakia, 080 01
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  - Prievidza, Slovakia, 97101
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  - Sabinov, Slovakia, 08301
    - Novo Nordisk Investigational Site
Slovenia
- - Brezice, Slovenia, 8250
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  - Jesenice, Slovenia, SI-4270
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  - Koper, Slovenia, SI-6000
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  - Murska Sobota, Slovenia, SI-9000
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  - Nova Gorica, Slovenia, SI-5000
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  - Nova Gorica, Slovenia, SI-5290
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South Africa
- Gauteng
  - Benoni, Gauteng, South Africa, 1501
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  - Cosmo City, Gauteng, South Africa, 2188
    - Novo Nordisk Investigational Site
  - Johannesburg, Gauteng, South Africa, 1818
    - Novo Nordisk Investigational Site
  - Johannesburg, Gauteng, South Africa, 2198
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  - Lenasia, Gauteng, South Africa, 1827
    - Novo Nordisk Investigational Site
  - Pretoria, Gauteng, South Africa, 0002
    - Novo Nordisk Investigational Site
  - Pretoria, Gauteng, South Africa, 0122
    - Novo Nordisk Investigational Site
- KwaZulu-Natal
  - Durban, KwaZulu-Natal, South Africa, 4092
    - Novo Nordisk Investigational Site
  - Durban, KwaZulu-Natal, South Africa, 4450
    - Novo Nordisk Investigational Site
  - Umkomaas, KwaZulu-Natal, South Africa, 4170
    - Novo Nordisk Investigational Site
Spain
- - Almeria, Spain, 04009
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  - Antequera, Spain, 29200
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  - Córdoba, Spain, 14004
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  - Fuenlabrada - Madrid, Spain, 28942
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  - Madrid, Spain, 28006
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  - Málaga, Spain, 29006
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  - Palma de Mallorca, Spain, 07010
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  - Segovia, Spain, 40002
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  - Sevilla, Spain, 41003
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Turkey
- - Adana, Turkey, 01130
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  - Ankara, Turkey, 06500
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  - Antalya, Turkey, 07058
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  - Denizli, Turkey, 20070
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  - Erzurum, Turkey, 25240
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  - Istanbul, Turkey, 34722
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  - Istanbul, Turkey, 34390
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  - Istanbul, Turkey, 34303
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  - Istanbul, Turkey, 34760
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  - Istanbul, Turkey, 34899
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  - Istanbul, Turkey, 34400
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  - Izmir, Turkey, 35100
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  - Izmir, Turkey, 35340
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  - Trabzon, Turkey, 61080
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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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening
Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening
Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors
Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)

Exclusion Criteria:

History or presence of pancreatitis (acute or chronic)
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
Subjects presently classified as being in New York Heart Association Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in

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 Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide Run-in period (12 weeks): subjects will be treated with metformin and insulin glargine (IGlar) U100. Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in will receive semaglutide for 52 weeks in addition to metformin and IGlar U100. Metformin will be considered as background therapy during the trial.	Drug: Semaglutide Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study. Drug: Insulin glargine U100 Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)
Active Comparator: Insulin aspart Run-in period (12 weeks): subjects will be treated with metformin and insulin IGlar U100. Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in receive insulin aspart for 52 weeks in addition to metformin and IGlar U100. Metformin will be considered as background therapy during the trial.	Drug: Insulin glargine U100 Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L) Drug: Insulin aspart Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days

Participant Group / Arm

Intervention / Treatment

Experimental: Semaglutide

Run-in period (12 weeks): subjects will be treated with metformin and insulin glargine (IGlar) U100.

Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in will receive semaglutide for 52 weeks in addition to metformin and IGlar U100.

Metformin will be considered as background therapy during the trial.

Drug: Semaglutide

Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.

Drug: Insulin glargine U100

Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)

Active Comparator: Insulin aspart

Run-in period (12 weeks): subjects will be treated with metformin and insulin IGlar U100.

Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in receive insulin aspart for 52 weeks in addition to metformin and IGlar U100.

Metformin will be considered as background therapy during the trial.

Drug: Insulin glargine U100

Drug: Insulin aspart

Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycated Haemoglobin (HbA1c) Time Frame: Baseline (week 0), week 52	Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52 Time Frame: From randomization (week 0) up to week 52	First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) up to week 52
Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52 Time Frame: From randomization (week 0) up to week 52	First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) up to week 52
Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52 Time Frame: From randomization (week 0) to week 52	Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52 Time Frame: From randomization (week 0) to week 52	Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52 Time Frame: From randomization (week 0) to week 52	Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration <= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52 Time Frame: From randomization (week 0) to week 52	Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52 Time Frame: From randomization (week 0) to week 52	Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose < 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose < 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Daily Basal Insulin Dose at Week 52 Time Frame: At week 52	Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	At week 52
Total Daily Insulin Dose at Week 52 Time Frame: At week 52	Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	At week 52
Change From Baseline to Week 52 in Body Weight (Kilogram (kg)) Time Frame: Baseline (week 0), week 52	Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) Time Frame: Baseline (week 0), week 52	Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP) Time Frame: Baseline (week 0), week 52	Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals) Time Frame: Baseline (week 0), week 52	Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Body Mass Index (BMI) Time Frame: Baseline (week 0), week 52	Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Waist Circumference Time Frame: Baseline (week 0), week 52	Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline Time Frame: Baseline (week 0), week 52	Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline) Time Frame: Baseline (week 0), week 52	Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) Time Frame: Baseline (week 0), week 52	Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) Time Frame: Baseline (week 0), week 52	Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline) Time Frame: Baseline (week 0), week 52	Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure Time Frame: Baseline (week 0), week 52	Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Pulse Rate Time Frame: Baseline (week 0), week 52	Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains Time Frame: Baseline (week 0), week 52	SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains Time Frame: Baseline (week 0), week 52	The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

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

Kellerer M, Kaltoft MS, Lawson J, Nielsen LL, Strojek K, Tabak O, Jacob S. Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial. Diabetes Obes Metab. 2022 Sep;24(9):1788-1799. doi: 10.1111/dom.14765. Epub 2022 Jun 29.

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)

October 1, 2018

Primary Completion (Actual)

February 22, 2021

Study Completion (Actual)

February 22, 2021

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN9535-4386
U1111-1200-0164 (Other Identifier: World Health Organization (WHO))
2017-003219-20 (Registry Identifier: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on Semaglutide

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