Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6)

A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: semaglutide; Drug: semaglutide; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 3297
• Phase: Phase 3

Contacts and Locations

Study Locations

• Algeria
  • Annaba, Algeria, 23000
    • Novo Nordisk Investigational Site
  • Oran, Algeria, 31000
    • Novo Nordisk Investigational Site
  • Setif, Algeria, 19000
    • Novo Nordisk Investigational Site
  • Tizi Ouzou, Algeria, 15000
    • Novo Nordisk Investigational Site
• Argentina
  • Caba, Argentina, C1093AAS
    • Novo Nordisk Investigational Site
  • Caba, Argentina, C1440AAD
    • Novo Nordisk Investigational Site
  • Caba, Argentina, C1180AAX
    • Novo Nordisk Investigational Site
  • Caba, Argentina
    • Novo Nordisk Investigational Site
  • Cordoba, Argentina, 5000
    • Novo Nordisk Investigational Site
  • Mar del Plata, Argentina, B7600FZN
    • Novo Nordisk Investigational Site
  • Morón, Argentina, B1708IFF
    • Novo Nordisk Investigational Site
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Novo Nordisk Investigational Site
    • St Leonards, New South Wales, Australia, 2065
      • Novo Nordisk Investigational Site
  • Queensland
    • Ipswich, Queensland, Australia, 4305
      • Novo Nordisk Investigational Site
  • South Australia
    • Keswick, South Australia, Australia, 5035
      • Novo Nordisk Investigational Site
    • Oaklands Park, South Australia, Australia, 5046
      • Novo Nordisk Investigational Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Novo Nordisk Investigational Site
    • Fitzroy, Victoria, Australia, 3065
      • Novo Nordisk Investigational Site
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Novo Nordisk Investigational Site
• Brazil
  • Porto Alegre, Brazil, 90035-170
    • Novo Nordisk Investigational Site
  • Para
    • Belém, Para, Brazil, 66073-000
      • Novo Nordisk Investigational Site
  • Parana
    • Curitiba, Parana, Brazil, 80030-110
      • Novo Nordisk Investigational Site
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13059-740
      • Novo Nordisk Investigational Site
    • São Paulo, Sao Paulo, Brazil, 05403-000
      • Novo Nordisk Investigational Site
    • São Paulo, Sao Paulo, Brazil, 01228-000
      • Novo Nordisk Investigational Site
    • São Paulo, Sao Paulo, Brazil, 01228-200
      • Novo Nordisk Investigational Site
    • São Paulo, Sao Paulo, Brazil, 04038-002
      • Novo Nordisk Investigational Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Novo Nordisk Investigational Site
  • Sofia, Bulgaria, 1606
    • Novo Nordisk Investigational Site
  • Sofia, Bulgaria, 1324
    • Novo Nordisk Investigational Site
  • Varna, Bulgaria, 9010
    • Novo Nordisk Investigational Site
• Canada
  • Quebec, Canada, G1V 4G5
    • Novo Nordisk Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2V 4J2
      • Novo Nordisk Investigational Site
    • Edmonton, Alberta, Canada, T6G 2E1
      • Novo Nordisk Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Novo Nordisk Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1E 2C2
      • Novo Nordisk Investigational Site
  • Ontario
    • Cambridge, Ontario, Canada, N1R 7L6
      • Novo Nordisk Investigational Site
    • Cornwall, Ontario, Canada, K6H 4M4
      • Novo Nordisk Investigational Site
    • London, Ontario, Canada, N6A 4V2
      • Novo Nordisk Investigational Site
    • Smiths Falls, Ontario, Canada, K7A 4W8
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M5C 2T2
      • Novo Nordisk Investigational Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novo Nordisk Investigational Site
  • Quebec
    • Drummondville, Quebec, Canada, J2B 7T1
      • Novo Nordisk Investigational Site
    • Montreal, Quebec, Canada, H4A 3T2
      • Novo Nordisk Investigational Site
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Novo Nordisk Investigational Site
• Denmark
  • Aarhus C, Denmark, 8000
    • Novo Nordisk Investigational Site
  • Gentofte, Denmark, 2820
    • Novo Nordisk Investigational Site
  • Hellerup, Denmark, 2900
    • Novo Nordisk Investigational Site
  • Hvidovre, Denmark, 2650
    • Novo Nordisk Investigational Site
  • Odense, Denmark, 5000
    • Novo Nordisk Investigational Site
• Germany
  • Elsterwerda, Germany, 04910
    • Novo Nordisk Investigational Site
  • Essen, Germany, 45219
    • Novo Nordisk Investigational Site
  • Falkensee, Germany, 14612
    • Novo Nordisk Investigational Site
  • Freiburg, Germany, 79106
    • Novo Nordisk Investigational Site
  • Hamburg, Germany, 22607
    • Novo Nordisk Investigational Site
  • Münster, Germany, 48145
    • Novo Nordisk Investigational Site
  • Oldenburg, Germany, 23758
    • Novo Nordisk Investigational Site
  • Saint Ingbert, Germany, 66386
    • Novo Nordisk Investigational Site
• India
  • New Delhi, India, 110095
    • Novo Nordisk Investigational Site
  • Pune, India, 411011
    • Novo Nordisk Investigational Site
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500082
      • Novo Nordisk Investigational Site
    • Hyderabad, Andhra Pradesh, India, 500034
      • Novo Nordisk Investigational Site
    • Hyderabad, Andhra Pradesh, India, 500003
      • Novo Nordisk Investigational Site
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • Novo Nordisk Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • Novo Nordisk Investigational Site
    • Mysore, Karnataka, India, 570001
      • Novo Nordisk Investigational Site
  • Kerala
    • Kochi, Kerala, India, 682041
      • Novo Nordisk Investigational Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400008
      • Novo Nordisk Investigational Site
    • Mumbai, Maharashtra, India, 400012
      • Novo Nordisk Investigational Site
    • Mumbai, Maharashtra, India, 400022
      • Novo Nordisk Investigational Site
    • Mumbai, Maharashtra, India, 400010
      • Novo Nordisk Investigational Site
    • Mumbai, Maharashtra, India, 400016
      • Novo Nordisk Investigational Site
  • New Delhi
    • Delhi, New Delhi, India, 110002
      • Novo Nordisk Investigational Site
    • New Dehli, New Delhi, India, 110029
      • Novo Nordisk Investigational Site
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • Novo Nordisk Investigational Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600086
      • Novo Nordisk Investigational Site
    • Vellore, Tamil Nadu, India, 632004
      • Novo Nordisk Investigational Site
  • West Bengal
    • Kolkata, West Bengal, India, 700054
      • Novo Nordisk Investigational Site
    • Kolkata, West Bengal, India, 700032
      • Novo Nordisk Investigational Site
• Israel
  • Holon, Israel, 58100
    • Novo Nordisk Investigational Site
  • Jerusalem, Israel, 91120
    • Novo Nordisk Investigational Site
  • Nahariya, Israel, 22100
    • Novo Nordisk Investigational Site
  • Petah-Tikva, Israel, 49100
    • Novo Nordisk Investigational Site
  • Tel Hashomer, Israel, 52621
    • Novo Nordisk Investigational Site
  • Tel-Aviv, Israel, 64239
    • Novo Nordisk Investigational Site
• Italy
  • Bergamo, Italy, 24127
    • Novo Nordisk Investigational Site
  • Chieti, Italy, 66100
    • Novo Nordisk Investigational Site
  • Olbia, Italy, 07026
    • Novo Nordisk Investigational Site
  • Padova, Italy, 35128
    • Novo Nordisk Investigational Site
  • Primo Piano Palazzina Ambulato, Italy, 40133
    • Novo Nordisk Investigational Site
  • Siena, Italy, 53100
    • Novo Nordisk Investigational Site
• Malaysia
  • Kota Samarahan, Malaysia, 94300
    • Novo Nordisk Investigational Site
  • Kuala Lumpur, Malaysia, 59100
    • Novo Nordisk Investigational Site
  • Kuching, Malaysia, 93586
    • Novo Nordisk Investigational Site
  • Melaka, Malaysia, 75400
    • Novo Nordisk Investigational Site
  • Serdang, Malaysia, 43000
    • Novo Nordisk Investigational Site
  • Seremban, Malaysia, 70300
    • Novo Nordisk Investigational Site
• Mexico
  • Aguascalientes, Mexico, 20230
    • Novo Nordisk Investigational Site
  • San Luis Potosi, Mexico, 78200
    • Novo Nordisk Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Novo Nordisk Investigational Site
    • Guadalajara, Jalisco, Mexico, 44130
      • Novo Nordisk Investigational Site
    • Guadalajara, Jalisco, Mexico, 44670
      • Novo Nordisk Investigational Site
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62250
      • Novo Nordisk Investigational Site
  • México, D.F.
    • Mexico City, México, D.F., Mexico, 03300
      • Novo Nordisk Investigational Site
    • Mexico City, México, D.F., Mexico, 14000
      • Novo Nordisk Investigational Site
    • México D.F., México, D.F., Mexico, 11550
      • Novo Nordisk Investigational Site
  • Tamaulipas
    • Ciudad Madero, Tamaulipas, Mexico, 89440
      • Novo Nordisk Investigational Site
• Poland
  • Bialystok, Poland, 15-445
    • Novo Nordisk Investigational Site
  • Gdansk, Poland, 80-858
    • Novo Nordisk Investigational Site
  • Lublin, Poland, 20-044
    • Novo Nordisk Investigational Site
  • Warszawa, Poland, 01-192
    • Novo Nordisk Investigational Site
  • Zabrze, Poland, 41-800
    • Novo Nordisk Investigational Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Novo Nordisk Investigational Site
  • Arkhangelsk, Russian Federation, 163001
    • Novo Nordisk Investigational Site
  • Barnaul, Russian Federation, 656045
    • Novo Nordisk Investigational Site
  • Kazan, Russian Federation, 420043
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 119435
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 117997
    • Novo Nordisk Investigational Site
  • Novosibirsk, Russian Federation, 630047
    • Novo Nordisk Investigational Site
  • Penza, Russian Federation, 440026
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 199034
    • Novo Nordisk Investigational Site
  • Saratov, Russian Federation, 410053
    • Novo Nordisk Investigational Site
  • Saratov, Russian Federation, 410031
    • Novo Nordisk Investigational Site
  • Smolensk, Russian Federation, 214019
    • Novo Nordisk Investigational Site
  • Yaroslavl, Russian Federation, 150062
    • Novo Nordisk Investigational Site
• Spain
  • Almería, Spain, 04001
    • Novo Nordisk Investigational Site
  • Antequera, Spain, 29200
    • Novo Nordisk Investigational Site
  • Pozuelo de Alarcon, Spain, 28223
    • Novo Nordisk Investigational Site
  • Sanlúcar De Barrameda - Cádiz-, Spain, 15540
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41010
    • Novo Nordisk Investigational Site
  • Vic (Barcelona), Spain, 08500
    • Novo Nordisk Investigational Site
• Taiwan
  • Chiayi City, Taiwan, 600
    • Novo Nordisk Investigational Site
  • Tainan city, Taiwan, 710
    • Novo Nordisk Investigational Site
  • Taipei, Taiwan, 114
    • Novo Nordisk Investigational Site
  • Taoyuan, Taiwan, 333
    • Novo Nordisk Investigational Site
• Thailand
  • Bangkok, Thailand, 10400
    • Novo Nordisk Investigational Site
  • Bangkok, Thailand, 10330
    • Novo Nordisk Investigational Site
  • Bangkok, Thailand, 10700
    • Novo Nordisk Investigational Site
• Turkey
  • Ankara, Turkey, 06110
    • Novo Nordisk Investigational Site
  • Ankara, Turkey, 06100
    • Novo Nordisk Investigational Site
  • Antalya, Turkey, 07058
    • Novo Nordisk Investigational Site
  • Canakkale, Turkey, 17020
    • Novo Nordisk Investigational Site
  • Denizli, Turkey, 20070
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34096
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34722
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34890
    • Novo Nordisk Investigational Site
  • Izmir, Turkey, 35340
    • Novo Nordisk Investigational Site
  • Kocaeli, Turkey, 41380
    • Novo Nordisk Investigational Site
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
    • Novo Nordisk Investigational Site
  • Birmingham, United Kingdom, B9 5SS
    • Novo Nordisk Investigational Site
  • Leeds, United Kingdom, LS25 1AN
    • Novo Nordisk Investigational Site
  • Liverpool, United Kingdom, L9 7AL
    • Novo Nordisk Investigational Site
  • Northwood, United Kingdom, HA6 2RN
    • Novo Nordisk Investigational Site
  • Sidcup, United Kingdom, DA14 6LT
    • Novo Nordisk Investigational Site
  • Swansea, United Kingdom, SA6 6NL
    • Novo Nordisk Investigational Site
  • Torquay, United Kingdom, TQ2 7AA
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Novo Nordisk Investigational Site
    • Birmingham, Alabama, United States, 35205-4731
      • Novo Nordisk Investigational Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Novo Nordisk Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Greenbrae, California, United States, 94904
      • Novo Nordisk Investigational Site
    • Lancaster, California, United States, 93534
      • Novo Nordisk Investigational Site
    • Los Angeles, California, United States, 90017-4006
      • Novo Nordisk Investigational Site
    • Mission Hills, California, United States, 91345
      • Novo Nordisk Investigational Site
    • Monterey, California, United States, 93940
      • Novo Nordisk Investigational Site
    • Northridge, California, United States, 91325
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92108
      • Novo Nordisk Investigational Site
    • San Ramon, California, United States, 94583
      • Novo Nordisk Investigational Site
    • Ventura, California, United States, 93003
      • Novo Nordisk Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Novo Nordisk Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Novo Nordisk Investigational Site
  • Florida
    • Bradenton, Florida, United States, 34201
      • Novo Nordisk Investigational Site
    • Crystal River, Florida, United States, 34429
      • Novo Nordisk Investigational Site
    • DeLand, Florida, United States, 32724
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Novo Nordisk Investigational Site
    • Melbourne, Florida, United States, 32901
      • Novo Nordisk Investigational Site
    • Melbourne, Florida, United States, 32934
      • Novo Nordisk Investigational Site
    • Ocala, Florida, United States, 34470
      • Novo Nordisk Investigational Site
    • Ponte Vedra, Florida, United States, 32081
      • Novo Nordisk Investigational Site
    • Saint Petersburg, Florida, United States, 33707
      • Novo Nordisk Investigational Site
    • Spring Hill, Florida, United States, 34609
      • Novo Nordisk Investigational Site
  • Georgia
    • Dunwoody, Georgia, United States, 30338
      • Novo Nordisk Investigational Site
    • Lawrenceville, Georgia, United States, 30046
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novo Nordisk Investigational Site
    • Crystal Lake, Illinois, United States, 60012
      • Novo Nordisk Investigational Site
    • Gurnee, Illinois, United States, 60031
      • Novo Nordisk Investigational Site
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • Novo Nordisk Investigational Site
    • Mishawaka, Indiana, United States, 46544
      • Novo Nordisk Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Novo Nordisk Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Novo Nordisk Investigational Site
    • Louisville, Kentucky, United States, 40206
      • Novo Nordisk Investigational Site
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Novo Nordisk Investigational Site
    • New Orleans, Louisiana, United States, 70112
      • Novo Nordisk Investigational Site
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • Novo Nordisk Investigational Site
    • North Dartmouth, Massachusetts, United States, 02747
      • Novo Nordisk Investigational Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Novo Nordisk Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Novo Nordisk Investigational Site
    • Kansas City, Missouri, United States, 64111
      • Novo Nordisk Investigational Site
    • Saint Louis, Missouri, United States, 63141
      • Novo Nordisk Investigational Site
    • Saint Louis, Missouri, United States, 63128
      • Novo Nordisk Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Novo Nordisk Investigational Site
    • Omaha, Nebraska, United States, 68198-3020
      • Novo Nordisk Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Novo Nordisk Investigational Site
    • Nashua, New Hampshire, United States, 03063
      • Novo Nordisk Investigational Site
  • New Jersey
    • Mine Hill, New Jersey, United States, 07803
      • Novo Nordisk Investigational Site
    • Toms River, New Jersey, United States, 08755-8050
      • Novo Nordisk Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • Novo Nordisk Investigational Site
    • New York, New York, United States, 10001
      • Novo Nordisk Investigational Site
    • Rochester, New York, United States, 14609
      • Novo Nordisk Investigational Site
    • Staten Island, New York, United States, 10301
      • Novo Nordisk Investigational Site
    • West Seneca, New York, United States, 14224
      • Novo Nordisk Investigational Site
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Novo Nordisk Investigational Site
    • Asheville, North Carolina, United States, 28801
      • Novo Nordisk Investigational Site
    • Chapel Hill, North Carolina, United States, 27517
      • Novo Nordisk Investigational Site
    • Greenville, North Carolina, United States, 27834
      • Novo Nordisk Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Novo Nordisk Investigational Site
    • Whiteville, North Carolina, United States, 28472
      • Novo Nordisk Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Novo Nordisk Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Novo Nordisk Investigational Site
    • Cleveland, Ohio, United States, 44106
      • Novo Nordisk Investigational Site
    • Franklin, Ohio, United States, 45005
      • Novo Nordisk Investigational Site
    • Mason, Ohio, United States, 45040-6815
      • Novo Nordisk Investigational Site
    • Maumee, Ohio, United States, 43537
      • Novo Nordisk Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009-1957
      • Novo Nordisk Investigational Site
    • McMurray, Pennsylvania, United States, 15317
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19114
      • Novo Nordisk Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Novo Nordisk Investigational Site
    • Myrtle Beach, South Carolina, United States, 29572
      • Novo Nordisk Investigational Site
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • Novo Nordisk Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • Novo Nordisk Investigational Site
    • Memphis, Tennessee, United States, 38163
      • Novo Nordisk Investigational Site
    • Nashville, Tennessee, United States, 37212
      • Novo Nordisk Investigational Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75390-9302
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75231
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75218
      • Novo Nordisk Investigational Site
    • Fort Worth, Texas, United States, 76132
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77074
      • Novo Nordisk Investigational Site
    • Irving, Texas, United States, 75061-2210
      • Novo Nordisk Investigational Site
    • Longview, Texas, United States, 75605
      • Novo Nordisk Investigational Site
    • Odessa, Texas, United States, 79761
      • Novo Nordisk Investigational Site
    • Plano, Texas, United States, 75075
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78224
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78228-3419
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77478
      • Novo Nordisk Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Novo Nordisk Investigational Site
  • Vermont
    • South Burlington, Vermont, United States, 05403-7205
      • Novo Nordisk Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Novo Nordisk Investigational Site
    • Winchester, Virginia, United States, 22601
      • Novo Nordisk Investigational Site
    • Winchester, Virginia, United States, 22601-3834
      • Novo Nordisk Investigational Site
  • Washington
    • Wenatchee, Washington, United States, 98801-2028
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Novo Nordisk Investigational Site

Participation Criteria

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: - Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Semaglutide placebo 0.5 mg	Drug: placebo; Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
Placebo Comparator: Semaglutide placebo 1.0 mg	Drug: placebo; Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
Experimental: Semaglutide 0.5 mg	Drug: semaglutide; Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin); Drug: semaglutide; Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
Experimental: Semaglutide 1.0 mg	Drug: semaglutide; Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin); Drug: semaglutide; Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke	Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.	Time from randomisation up to end of follow-up (scheduled at week 109)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome	Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)	Time from randomisation up to end of follow-up (scheduled at week 109)
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome	Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).	Time from randomisation up to end of follow-up (scheduled at week 109)
Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke	Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.	Time from randomisation up to end of follow-up (scheduled at week 109)
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)	Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.	Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose	Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.	Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight	Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.	Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile	Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).	Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio	Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.	Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs	Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).	Week 0, up to week 104
Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events	Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.	Week 0 - 109
Incidence During the Trial in Other Treatment Outcomes: Adverse Events	Rates (event rate per 100 years of exposure) of treatment emergent adverse events.	Weeks 0-109
Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies	The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.	Weeks 0-109
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)	Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.	Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)	Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).	Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)	Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).	Week 0, up to week 104

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.
• Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
• Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.
• DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.
• Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
• 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.
• Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.
• Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.
• Vilsboll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simo R, Helmark IC, Wijayasinghe N, Larsen M. Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy. Diabetes Obes Metab. 2018 Apr;20(4):889-897. doi: 10.1111/dom.13172. Epub 2018 Jan 8.
• Leiter LA, Bain SC, Hramiak I, Jodar E, Madsbad S, Gondolf T, Hansen T, Holst I, Lingvay I. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol. 2019 Jun 6;18(1):73. doi: 10.1186/s12933-019-0871-8.
• 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.
• 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.
• Verma S, Al-Omran M, Leiter LA, Mazer CD, Rasmussen S, Saevereid HA, Sejersten Ripa M, Bonaca MP. Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Diabetes Obes Metab. 2022 Jul;24(7):1288-1299. doi: 10.1111/dom.14700. Epub 2022 Apr 11.
• 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.
• Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4.
• Verma S, Bain SC, Honore JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12.
• Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3.
• Jodar E, Michelsen M, Polonsky W, Rea R, Sandberg A, Vilsboll T, Warren M, Harring S, Ziegler U, Bain S. Semaglutide improves health-related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6). Diabetes Obes Metab. 2020 Aug;22(8):1339-1347. doi: 10.1111/dom.14039. Epub 2020 Apr 27.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2013
• Primary Completion (Actual): March 15, 2016
• Study Completion (Actual): March 15, 2016

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9535-3744; 2012-002839-28 (EudraCT Number); U1111-1131-7227 (Other Identifier: WHO)