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DiabetesPhase 3SUSTAIN™ 6NCT01720446

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

A Phase 3 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 253 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,297 participants
Where
253 sitesin 21 countries
Study dates
21 Feb 2013to 15 Mar 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

253 sites in 21 countries.

253 sites in 21 countries

United States97 sites

  • Novo Nordisk Investigational Site

    Albany, New York, 12206

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Asheboro, North Carolina, 27203

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28801

  • Novo Nordisk Investigational Site

    Aurora, Colorado, 80045

  • Novo Nordisk Investigational Site

    Bartlett, Tennessee, 38133

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009-1957

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35205-4731

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35216

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Chandler, Arizona, 85224

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina, 27517

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri, 63017

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45219

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44106

  • Novo Nordisk Investigational Site

    Crystal Lake, Illinois, 60012

  • Novo Nordisk Investigational Site

    Crystal River, Florida, 34429

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75218

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-9302

  • Novo Nordisk Investigational Site

    DeLand, Florida, 32724

  • Novo Nordisk Investigational Site

    Dunwoody, Georgia, 30338

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76132

  • Novo Nordisk Investigational Site

    Franklin, Ohio, 45005

  • Novo Nordisk Investigational Site

    Greenbrae, California, 94904

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Gurnee, Illinois, 60031

  • Novo Nordisk Investigational Site

    Houston, Texas, 77074

  • Novo Nordisk Investigational Site

    Irving, Texas, 75061-2210

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32216

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan, 49048

  • Novo Nordisk Investigational Site

    Kansas City, Missouri, 64111

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Lancaster, California, 93534

  • Novo Nordisk Investigational Site

    Lawrenceville, Georgia, 30046

  • Novo Nordisk Investigational Site

    Lebanon, New Hampshire, 03756

  • Novo Nordisk Investigational Site

    Longview, Texas, 75605

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90017-4006

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40206

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Madison, Wisconsin, 53792

  • Novo Nordisk Investigational Site

    Mason, Ohio, 45040-6815

  • Novo Nordisk Investigational Site

    Maumee, Ohio, 43537

  • Novo Nordisk Investigational Site

    McMurray, Pennsylvania, 15317

  • Novo Nordisk Investigational Site

    Melbourne, Florida, 32901

  • Novo Nordisk Investigational Site

    Melbourne, Florida, 32934

  • Novo Nordisk Investigational Site

    Memphis, Tennessee, 38163

  • Novo Nordisk Investigational Site

    Methuen, Massachusetts, 01844

  • Novo Nordisk Investigational Site

    Michigan City, Indiana, 46360

  • Novo Nordisk Investigational Site

    Mine Hill, New Jersey, 07803

  • Novo Nordisk Investigational Site

    Mishawaka, Indiana, 46544

  • Novo Nordisk Investigational Site

    Mission Hills, California, 91345

  • Novo Nordisk Investigational Site

    Monroe, Louisiana, 71203

  • Novo Nordisk Investigational Site

    Monterey, California, 93940

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina, 29572

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37212

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70112

  • Novo Nordisk Investigational Site

    New York, New York, 10001

  • Novo Nordisk Investigational Site

    North Dartmouth, Massachusetts, 02747

  • Novo Nordisk Investigational Site

    Northridge, California, 91325

  • Novo Nordisk Investigational Site

    Ocala, Florida, 34470

  • Novo Nordisk Investigational Site

    Odessa, Texas, 79761

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68114

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68198-3020

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19114

  • Novo Nordisk Investigational Site

    Plano, Texas, 75075

  • Novo Nordisk Investigational Site

    Ponte Vedra, Florida, 32081

  • Novo Nordisk Investigational Site

    Raleigh, North Carolina, 27612

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23219

  • Novo Nordisk Investigational Site

    Rochester, New York, 14609

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84107

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78224

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78228-3419

  • Novo Nordisk Investigational Site

    San Diego, California, 92108

  • Novo Nordisk Investigational Site

    San Ramon, California, 94583

  • Novo Nordisk Investigational Site

    South Burlington, Vermont, 05403-7205

  • Novo Nordisk Investigational Site

    Spring Hill, Florida, 34609

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63128

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63141

  • Novo Nordisk Investigational Site

    St. Petersburg, Florida, 33707

  • Novo Nordisk Investigational Site

    Staten Island, New York, 10301

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77478

  • Novo Nordisk Investigational Site

    Toms River, New Jersey, 08755-8050

  • Novo Nordisk Investigational Site

    Ventura, California, 93003

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut, 06708

  • Novo Nordisk Investigational Site

    Wenatchee, Washington, 98801-2028

  • Novo Nordisk Investigational Site

    West Seneca, New York, 14224

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina, 28472

  • Novo Nordisk Investigational Site

    Wichita, Kansas, 67205

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

  • Novo Nordisk Investigational Site

    Winchester, Virginia, 22601-3834

  • Novo Nordisk Investigational Site

    Winchester, Virginia, 22601

Other trials in United States

India21 sites

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560034

  • Novo Nordisk Investigational Site

    Chandigarh, Punjab, 160012

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600086

  • Novo Nordisk Investigational Site

    Delhi, New Delhi, 110002

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500003

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500034

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500082

  • Novo Nordisk Investigational Site

    Kochi, Kerala, 682041

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700032

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700054

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400008

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400010

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400012

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400016

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400022

  • Novo Nordisk Investigational Site

    Mysore, Karnataka, 570001

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi, 110029

  • Novo Nordisk Investigational Site

    New Delhi, 110095

  • Novo Nordisk Investigational Site

    Pune, 411011

  • Novo Nordisk Investigational Site

    Vellore, Tamil Nadu, 632004

  • Novo Nordisk Investigational Site

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Canada14 sites

  • Novo Nordisk Investigational Site

    Calgary, Alberta, T2V 4J2

  • Novo Nordisk Investigational Site

    Cambridge, Ontario, N1R 7L6

  • Novo Nordisk Investigational Site

    Cornwall, Ontario, K6H 4M4

  • Novo Nordisk Investigational Site

    Drummondville, Quebec, J2B 7T1

  • Novo Nordisk Investigational Site

    Edmonton, Alberta, T6G 2E1

  • Novo Nordisk Investigational Site

    London, Ontario, N6A 4V2

  • Novo Nordisk Investigational Site

    Montreal, Quebec, H4A 3T2

  • Novo Nordisk Investigational Site

    Québec, G1V 4G5

  • Novo Nordisk Investigational Site

    Smiths Falls, Ontario, K7A 4W8

  • Novo Nordisk Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M5C 2T2

  • Novo Nordisk Investigational Site

    Victoriaville, Quebec, G6P 6P6

  • Novo Nordisk Investigational Site

    Waterloo, Ontario, N2J 1C4

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Russia13 sites

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163001

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163045

  • Novo Nordisk Investigational Site

    Barnaul, 656045

  • Novo Nordisk Investigational Site

    Kazan', 420043

  • Novo Nordisk Investigational Site

    Moscow, 117997

  • Novo Nordisk Investigational Site

    Moscow, 119435

  • Novo Nordisk Investigational Site

    Novosibirsk, 630047

  • Novo Nordisk Investigational Site

    Penza, 440026

  • Novo Nordisk Investigational Site

    Saint Petersburg, 199034

  • Novo Nordisk Investigational Site

    Saratov, 410031

  • Novo Nordisk Investigational Site

    Saratov, 410053

  • Novo Nordisk Investigational Site

    Smolensk, 214019

  • Novo Nordisk Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Mexico10 sites

  • Novo Nordisk Investigational Site

    Aguascalientes, 20230

  • Novo Nordisk Investigational Site

    Ciudad Madero, Tamaulipas, 89440

  • Novo Nordisk Investigational Site

    Cuernavaca, Morelos, 62250

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44130

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44600

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44670

  • Novo Nordisk Investigational Site

    Mexico City, México, D.F., 03300

  • Novo Nordisk Investigational Site

    Mexico City, México, D.F., 14000

  • Novo Nordisk Investigational Site

    México D.F., México, D.F., 11550

  • Novo Nordisk Investigational Site

    San Luis Potosí City, 78200

Other trials in Mexico

Turkey (Türkiye)10 sites

  • Novo Nordisk Investigational Site

    Ankara, 06100

  • Novo Nordisk Investigational Site

    Ankara, 06110

  • Novo Nordisk Investigational Site

    Antalya, 07058

  • Novo Nordisk Investigational Site

    Çanakkale, 17020

  • Novo Nordisk Investigational Site

    Denizli, 20070

  • Novo Nordisk Investigational Site

    Istanbul, 34096

  • Novo Nordisk Investigational Site

    Istanbul, 34722

  • Novo Nordisk Investigational Site

    Istanbul, 34890

  • Novo Nordisk Investigational Site

    Izmir, 35340

  • Novo Nordisk Investigational Site

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Australia8 sites

  • Novo Nordisk Investigational Site

    Blacktown, New South Wales, 2148

  • Novo Nordisk Investigational Site

    Box Hill, Victoria, 3128

  • Novo Nordisk Investigational Site

    Fitzroy, Victoria, 3065

  • Novo Nordisk Investigational Site

    Fremantle, Western Australia, 6160

  • Novo Nordisk Investigational Site

    Ipswich, Queensland, 4305

  • Novo Nordisk Investigational Site

    Keswick, South Australia, 5035

  • Novo Nordisk Investigational Site

    Oaklands Park, South Australia, 5046

  • Novo Nordisk Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

Brazil8 sites

  • Novo Nordisk Investigational Site

    Belém, Pará, 66073-000

  • Novo Nordisk Investigational Site

    Campinas, São Paulo, 13059-740

  • Novo Nordisk Investigational Site

    Curitiba, Paraná, 80030-110

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-170

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-000

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-200

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 04038-002

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Germany8 sites

  • Novo Nordisk Investigational Site

    Elsterwerda, 04910

  • Novo Nordisk Investigational Site

    Essen, 45219

  • Novo Nordisk Investigational Site

    Falkensee, 14612

  • Novo Nordisk Investigational Site

    Freiburg im Breisgau, 79106

  • Novo Nordisk Investigational Site

    Hamburg, 22607

  • Novo Nordisk Investigational Site

    Münster, 48145

  • Novo Nordisk Investigational Site

    Oldenburg, 23758

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386

Other trials in Germany

United Kingdom8 sites

  • Novo Nordisk Investigational Site

    Aberdeen, AB25 2ZD

  • Novo Nordisk Investigational Site

    Birmingham, B9 5SS

  • Novo Nordisk Investigational Site

    Leeds, LS25 1AN

  • Novo Nordisk Investigational Site

    Liverpool, L9 7AL

  • Novo Nordisk Investigational Site

    Northwood, HA6 2RN

  • Novo Nordisk Investigational Site

    Sidcup, DA14 6LT

  • Novo Nordisk Investigational Site

    Swansea, SA6 6NL

  • Novo Nordisk Investigational Site

    Torquay, TQ2 7AA

Other trials in United Kingdom

Argentina7 sites

  • Novo Nordisk Investigational Site

    CABA, C1093AAS

  • Novo Nordisk Investigational Site

    CABA, C1180AAX

  • Novo Nordisk Investigational Site

    CABA, C1440AAD

  • Novo Nordisk Investigational Site

    CABA

  • Novo Nordisk Investigational Site

    Córdoba, 5000

  • Novo Nordisk Investigational Site

    Mar del Plata, B7600FZN

  • Novo Nordisk Investigational Site

    Morón, B1708IFF

Other trials in Argentina

Israel6 sites

  • Novo Nordisk Investigational Site

    Holon, 58100

  • Novo Nordisk Investigational Site

    Jerusalem, 91120

  • Novo Nordisk Investigational Site

    Nahariya, 22100

  • Novo Nordisk Investigational Site

    Petah Tikva, 49100

  • Novo Nordisk Investigational Site

    Tel Aviv, 64239

  • Novo Nordisk Investigational Site

    Tel HaShomer, 52621

Other trials in Israel

Italy6 sites

  • Novo Nordisk Investigational Site

    Bergamo, 24127

  • Novo Nordisk Investigational Site

    Chieti, 66100

  • Novo Nordisk Investigational Site

    Olbia, 07026

  • Novo Nordisk Investigational Site

    Padova, 35128

  • Novo Nordisk Investigational Site

    Primo Piano Palazzina Ambulato, 40133

  • Novo Nordisk Investigational Site

    Siena, 53100

Other trials in Italy

Malaysia6 sites

  • Novo Nordisk Investigational Site

    Kota Samarahan, 94300

  • Novo Nordisk Investigational Site

    Kuala Lumpur, 59100

  • Novo Nordisk Investigational Site

    Kuching, 93586

  • Novo Nordisk Investigational Site

    Malacca, 75400

  • Novo Nordisk Investigational Site

    Serdang, 43000

  • Novo Nordisk Investigational Site

    Seremban, 70300

Other trials in Malaysia

Spain6 sites

  • Novo Nordisk Investigational Site

    Almería, 04001

  • Novo Nordisk Investigational Site

    Antequera, 29200

  • Novo Nordisk Investigational Site

    Pozuelo de Alarcón, 28223

  • Novo Nordisk Investigational Site

    Sanlúcar de Barrameda - Cádiz-, 15540

  • Novo Nordisk Investigational Site

    Seville, 41010

  • Novo Nordisk Investigational Site

    Vic (Barcelona), 08500

Other trials in Spain

Denmark5 sites

  • Novo Nordisk Investigational Site

    Aarhus C, 8000

  • Novo Nordisk Investigational Site

    Gentofte Municipality, 2820

  • Novo Nordisk Investigational Site

    Hellerup, 2900

  • Novo Nordisk Investigational Site

    Hvidovre, 2650

  • Novo Nordisk Investigational Site

    Odense, 5000

Other trials in Denmark

Poland5 sites

  • Novo Nordisk Investigational Site

    Bialystok, 15-445

  • Novo Nordisk Investigational Site

    Gdansk, 80-858

  • Novo Nordisk Investigational Site

    Lublin, 20-044

  • Novo Nordisk Investigational Site

    Warsaw, 01-192

  • Novo Nordisk Investigational Site

    Zabrze, 41-800

Other trials in Poland

Algeria4 sites

  • Novo Nordisk Investigational Site

    Annaba, 23000

  • Novo Nordisk Investigational Site

    Oran, 31000

  • Novo Nordisk Investigational Site

    Sétif, 19000

  • Novo Nordisk Investigational Site

    Tizi Ouzou, 15000

Other trials in Algeria

Bulgaria4 sites

  • Novo Nordisk Investigational Site

    Pleven, 5800

  • Novo Nordisk Investigational Site

    Sofia, 1324

  • Novo Nordisk Investigational Site

    Sofia, 1606

  • Novo Nordisk Investigational Site

    Varna, 9010

Other trials in Bulgaria

Taiwan4 sites

  • Novo Nordisk Investigational Site

    Chiayi City, 600

  • Novo Nordisk Investigational Site

    Tainan, 710

  • Novo Nordisk Investigational Site

    Taipei, 114

  • Novo Nordisk Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Thailand3 sites

  • Novo Nordisk Investigational Site

    Bangkok, 10330

  • Novo Nordisk Investigational Site

    Bangkok, 10400

  • Novo Nordisk Investigational Site

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: 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.

Being tested
semaglutide, placebo
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutideDrug

    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)

  • semaglutideDrug

    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)

  • placeboDrug

    Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).

Study groups in NCT01720446
Study groupRoleWhat they receive
Semaglutide 0.5 mgExperimentalNot described
Receives: Drug: semaglutide
Semaglutide 1.0 mgExperimentalNot described
Receives: Drug: semaglutide
Semaglutide placebo 0.5 mgPlacebo comparatorNot described
Receives: Drug: placebo
Semaglutide placebo 1.0 mgPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Time from randomisation up to end of follow-up (scheduled at week 109)

Secondary outcomes (15)

  1. 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)

    Measured: Time from randomisation up to end of follow-up (scheduled at week 109)

  2. 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).

    Measured: Time from randomisation up to end of follow-up (scheduled at week 109)

  3. 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.

    Measured: Time from randomisation up to end of follow-up (scheduled at week 109)

  4. 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.

    Measured: Week 0, up to week 104

  5. 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.

    Measured: Week 0, up to week 104

  6. 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.

    Measured: Week 0, up to week 104

  7. 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).

    Measured: Week 0, up to week 104

  8. 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.

    Measured: Week 0, up to week 104

  9. 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).

    Measured: Week 0, up to week 104

  10. 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.

    Measured: Week 0 - 109

  11. Incidence During the Trial in Other Treatment Outcomes: Adverse Events

    Rates (event rate per 100 years of exposure) of treatment emergent adverse events.

    Measured: Weeks 0-109

  12. 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.

    Measured: Weeks 0-109

  13. 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.

    Measured: Week 0, up to week 104

  14. 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).

    Measured: Week 0, up to week 104

  15. 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).

    Measured: Week 0, up to week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2012 (estimated)
  2. Study start21 Feb 2013
  3. Primary completion15 Mar 2016
  4. Study completion15 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720446
Sponsor's protocol ID
NN9535-3744
Other IDs
2012-002839-28, U1111-1131-7227
Acronym
SUSTAIN™ 6
Status last verified
Jun 2019
First submitted
29 Oct 2012
Last updated
27 Jun 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 30851070

  • 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.

    PubMed 27633186

  • 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.

    PubMed 29178519

  • 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.

    PubMed 29907893

  • 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.

    PubMed 30615985

  • 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.

    PubMed 31167654

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

  • Bain SC, Belmar N, Hoff ST, Husain M, Rasmussen S, Vilsboll T, Petrie MC. Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6. Diabetes Ther. 2025 Jan;16(1):15-28. doi: 10.1007/s13300-024-01659-7. Epub 2024 Nov 9.

    PubMed 39520501

  • Rossing P, Bain SC, Bosch-Traberg H, Sokareva E, Heerspink HJL, Rasmussen S, Mellbin LG. Effect of semaglutide on major adverse cardiovascular events by baseline kidney parameters in participants with type 2 diabetes and at high risk of cardiovascular disease: SUSTAIN 6 and PIONEER 6 post hoc pooled analysis. Cardiovasc Diabetol. 2023 Aug 24;22(1):220. doi: 10.1186/s12933-023-01949-7.

    PubMed 37620807

  • 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.

    PubMed 35582947

  • 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.

    PubMed 35484580

  • 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.

    PubMed 35332654

  • 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.

    PubMed 33606902

  • 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.

    PubMed 32998732

  • 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.

    PubMed 32744418

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 253 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 253 sites in United States, India, Canada, Russia, Mexico and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (time frame: Time from randomisation up to end of follow-up (scheduled at week 109)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01720446, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.

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