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

Diabetes Mellitus, Type 2 Clinical Trial

— SUSTAIN™ 6  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720446
• Other study ID #: NN9535-3744
• Secondary ID: 2012-002839-28U1
• Status: Completed
• Phase: Phase 3
• Start date: February 21, 2013
• Est. completion date: March 15, 2016

Study information

• Verified date: June 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3297
• Est. completion date: March 15, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Annaba
Algeria	Novo Nordisk Investigational Site	Oran
Algeria	Novo Nordisk Investigational Site	Setif
Algeria	Novo Nordisk Investigational Site	Tizi Ouzou
Argentina	Novo Nordisk Investigational Site	Caba
Argentina	Novo Nordisk Investigational Site	Caba
Argentina	Novo Nordisk Investigational Site	Caba
Argentina	Novo Nordisk Investigational Site	Caba
Argentina	Novo Nordisk Investigational Site	Cordoba
Argentina	Novo Nordisk Investigational Site	Mar del Plata
Argentina	Novo Nordisk Investigational Site	Morón
Australia	Novo Nordisk Investigational Site	Blacktown	New South Wales
Australia	Novo Nordisk Investigational Site	Box Hill	Victoria
Australia	Novo Nordisk Investigational Site	Fitzroy	Victoria
Australia	Novo Nordisk Investigational Site	Fremantle	Western Australia
Australia	Novo Nordisk Investigational Site	Ipswich	Queensland
Australia	Novo Nordisk Investigational Site	Keswick	South Australia
Australia	Novo Nordisk Investigational Site	Oaklands Park	South Australia
Australia	Novo Nordisk Investigational Site	St Leonards	New South Wales
Brazil	Novo Nordisk Investigational Site	Belém	Para
Brazil	Novo Nordisk Investigational Site	Campinas	Sao Paulo
Brazil	Novo Nordisk Investigational Site	Curitiba	Parana
Brazil	Novo Nordisk Investigational Site	Porto Alegre
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Bulgaria	Novo Nordisk Investigational Site	Pleven
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Varna
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Cambridge	Ontario
Canada	Novo Nordisk Investigational Site	Cornwall	Ontario
Canada	Novo Nordisk Investigational Site	Drummondville	Quebec
Canada	Novo Nordisk Investigational Site	Edmonton	Alberta
Canada	Novo Nordisk Investigational Site	London	Ontario
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
Canada	Novo Nordisk Investigational Site	Quebec
Canada	Novo Nordisk Investigational Site	Smiths Falls	Ontario
Canada	Novo Nordisk Investigational Site	St. John's	Newfoundland and Labrador
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Canada	Novo Nordisk Investigational Site	Victoriaville	Quebec
Canada	Novo Nordisk Investigational Site	Waterloo	Ontario
Canada	Novo Nordisk Investigational Site	Winnipeg	Manitoba
Denmark	Novo Nordisk Investigational Site	Aarhus C
Denmark	Novo Nordisk Investigational Site	Gentofte
Denmark	Novo Nordisk Investigational Site	Hellerup
Denmark	Novo Nordisk Investigational Site	Hvidovre
Denmark	Novo Nordisk Investigational Site	Odense
Germany	Novo Nordisk Investigational Site	Elsterwerda
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Falkensee
Germany	Novo Nordisk Investigational Site	Freiburg
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Oldenburg
Germany	Novo Nordisk Investigational Site	Saint Ingbert
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Chandigarh	Punjab
India	Novo Nordisk Investigational Site	Chennai	Tamil Nadu
India	Novo Nordisk Investigational Site	Delhi	New Delhi
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Kochi	Kerala
India	Novo Nordisk Investigational Site	Kolkata	West Bengal
India	Novo Nordisk Investigational Site	Kolkata	West Bengal
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mysore	Karnataka
India	Novo Nordisk Investigational Site	New Dehli	New Delhi
India	Novo Nordisk Investigational Site	New Delhi
India	Novo Nordisk Investigational Site	Pune
India	Novo Nordisk Investigational Site	Vellore	Tamil Nadu
India	Novo Nordisk Investigational Site	Visakhapatnam	Andhra Pradesh
Israel	Novo Nordisk Investigational Site	Holon
Israel	Novo Nordisk Investigational Site	Jerusalem
Israel	Novo Nordisk Investigational Site	Nahariya
Israel	Novo Nordisk Investigational Site	Petah-Tikva
Israel	Novo Nordisk Investigational Site	Tel Hashomer
Israel	Novo Nordisk Investigational Site	Tel-Aviv
Italy	Novo Nordisk Investigational Site	Bergamo
Italy	Novo Nordisk Investigational Site	Chieti
Italy	Novo Nordisk Investigational Site	Olbia
Italy	Novo Nordisk Investigational Site	Padova
Italy	Novo Nordisk Investigational Site	Primo Piano Palazzina Ambulato
Italy	Novo Nordisk Investigational Site	Siena
Malaysia	Novo Nordisk Investigational Site	Kota Samarahan
Malaysia	Novo Nordisk Investigational Site	Kuala Lumpur
Malaysia	Novo Nordisk Investigational Site	Kuching
Malaysia	Novo Nordisk Investigational Site	Melaka
Malaysia	Novo Nordisk Investigational Site	Serdang
Malaysia	Novo Nordisk Investigational Site	Seremban
Mexico	Novo Nordisk Investigational Site	Aguascalientes
Mexico	Novo Nordisk Investigational Site	Ciudad Madero	Tamaulipas
Mexico	Novo Nordisk Investigational Site	Cuernavaca	Morelos
Mexico	Novo Nordisk Investigational Site	Guadalajara	Jalisco
Mexico	Novo Nordisk Investigational Site	Guadalajara	Jalisco
Mexico	Novo Nordisk Investigational Site	Guadalajara	Jalisco
Mexico	Novo Nordisk Investigational Site	Mexico City	México, D.F.
Mexico	Novo Nordisk Investigational Site	Mexico City	México, D.F.
Mexico	Novo Nordisk Investigational Site	México D.F.	México, D.F.
Mexico	Novo Nordisk Investigational Site	San Luis Potosi
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Gdansk
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Warszawa
Poland	Novo Nordisk Investigational Site	Zabrze
Russian Federation	Novo Nordisk Investigational Site	Arkhangelsk
Russian Federation	Novo Nordisk Investigational Site	Arkhangelsk
Russian Federation	Novo Nordisk Investigational Site	Barnaul
Russian Federation	Novo Nordisk Investigational Site	Kazan
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Novosibirsk
Russian Federation	Novo Nordisk Investigational Site	Penza
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Saratov
Russian Federation	Novo Nordisk Investigational Site	Saratov
Russian Federation	Novo Nordisk Investigational Site	Smolensk
Russian Federation	Novo Nordisk Investigational Site	Yaroslavl
Spain	Novo Nordisk Investigational Site	Almería
Spain	Novo Nordisk Investigational Site	Antequera
Spain	Novo Nordisk Investigational Site	Pozuelo de Alarcon
Spain	Novo Nordisk Investigational Site	Sanlúcar De Barrameda - Cádiz-
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Vic (Barcelona)
Taiwan	Novo Nordisk Investigational Site	Chiayi City
Taiwan	Novo Nordisk Investigational Site	Tainan city
Taiwan	Novo Nordisk Investigational Site	Taipei
Taiwan	Novo Nordisk Investigational Site	Taoyuan
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Novo Nordisk Investigational Site	Bangkok
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Antalya
Turkey	Novo Nordisk Investigational Site	Canakkale
Turkey	Novo Nordisk Investigational Site	Denizli
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Izmir
Turkey	Novo Nordisk Investigational Site	Kocaeli
United Kingdom	Novo Nordisk Investigational Site	Aberdeen
United Kingdom	Novo Nordisk Investigational Site	Birmingham
United Kingdom	Novo Nordisk Investigational Site	Leeds
United Kingdom	Novo Nordisk Investigational Site	Liverpool
United Kingdom	Novo Nordisk Investigational Site	Northwood
United Kingdom	Novo Nordisk Investigational Site	Sidcup
United Kingdom	Novo Nordisk Investigational Site	Swansea
United Kingdom	Novo Nordisk Investigational Site	Torquay
United States	Novo Nordisk Investigational Site	Albany	New York
United States	Novo Nordisk Investigational Site	Anaheim	California
United States	Novo Nordisk Investigational Site	Asheboro	North Carolina
United States	Novo Nordisk Investigational Site	Asheville	North Carolina
United States	Novo Nordisk Investigational Site	Aurora	Colorado
United States	Novo Nordisk Investigational Site	Bartlett	Tennessee
United States	Novo Nordisk Investigational Site	Beaver	Pennsylvania
United States	Novo Nordisk Investigational Site	Birmingham	Alabama
United States	Novo Nordisk Investigational Site	Birmingham	Alabama
United States	Novo Nordisk Investigational Site	Bradenton	Florida
United States	Novo Nordisk Investigational Site	Chandler	Arizona
United States	Novo Nordisk Investigational Site	Chapel Hill	North Carolina
United States	Novo Nordisk Investigational Site	Chesterfield	Missouri
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Cleveland	Ohio
United States	Novo Nordisk Investigational Site	Crystal Lake	Illinois
United States	Novo Nordisk Investigational Site	Crystal River	Florida
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	DeLand	Florida
United States	Novo Nordisk Investigational Site	Dunwoody	Georgia
United States	Novo Nordisk Investigational Site	Fort Worth	Texas
United States	Novo Nordisk Investigational Site	Franklin	Ohio
United States	Novo Nordisk Investigational Site	Greenbrae	California
United States	Novo Nordisk Investigational Site	Greenville	North Carolina
United States	Novo Nordisk Investigational Site	Greer	South Carolina
United States	Novo Nordisk Investigational Site	Gurnee	Illinois
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Irving	Texas
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Kalamazoo	Michigan
United States	Novo Nordisk Investigational Site	Kansas City	Missouri
United States	Novo Nordisk Investigational Site	Kingsport	Tennessee
United States	Novo Nordisk Investigational Site	Lancaster	California
United States	Novo Nordisk Investigational Site	Lawrenceville	Georgia
United States	Novo Nordisk Investigational Site	Lebanon	New Hampshire
United States	Novo Nordisk Investigational Site	Longview	Texas
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Louisville	Kentucky
United States	Novo Nordisk Investigational Site	Louisville	Kentucky
United States	Novo Nordisk Investigational Site	Madison	Wisconsin
United States	Novo Nordisk Investigational Site	Mason	Ohio
United States	Novo Nordisk Investigational Site	Maumee	Ohio
United States	Novo Nordisk Investigational Site	McMurray	Pennsylvania
United States	Novo Nordisk Investigational Site	Melbourne	Florida
United States	Novo Nordisk Investigational Site	Melbourne	Florida
United States	Novo Nordisk Investigational Site	Memphis	Tennessee
United States	Novo Nordisk Investigational Site	Methuen	Massachusetts
United States	Novo Nordisk Investigational Site	Michigan City	Indiana
United States	Novo Nordisk Investigational Site	Mine Hill	New Jersey
United States	Novo Nordisk Investigational Site	Mishawaka	Indiana
United States	Novo Nordisk Investigational Site	Mission Hills	California
United States	Novo Nordisk Investigational Site	Monroe	Louisiana
United States	Novo Nordisk Investigational Site	Monterey	California
United States	Novo Nordisk Investigational Site	Myrtle Beach	South Carolina
United States	Novo Nordisk Investigational Site	Nashua	New Hampshire
United States	Novo Nordisk Investigational Site	Nashville	Tennessee
United States	Novo Nordisk Investigational Site	New Orleans	Louisiana
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	North Dartmouth	Massachusetts
United States	Novo Nordisk Investigational Site	Northridge	California
United States	Novo Nordisk Investigational Site	Ocala	Florida
United States	Novo Nordisk Investigational Site	Odessa	Texas
United States	Novo Nordisk Investigational Site	Oklahoma City	Oklahoma
United States	Novo Nordisk Investigational Site	Omaha	Nebraska
United States	Novo Nordisk Investigational Site	Omaha	Nebraska
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Plano	Texas
United States	Novo Nordisk Investigational Site	Ponte Vedra	Florida
United States	Novo Nordisk Investigational Site	Raleigh	North Carolina
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	Rochester	New York
United States	Novo Nordisk Investigational Site	Saint Louis	Missouri
United States	Novo Nordisk Investigational Site	Saint Louis	Missouri
United States	Novo Nordisk Investigational Site	Saint Petersburg	Florida
United States	Novo Nordisk Investigational Site	Salt Lake City	Utah
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	San Ramon	California
United States	Novo Nordisk Investigational Site	South Burlington	Vermont
United States	Novo Nordisk Investigational Site	Spring Hill	Florida
United States	Novo Nordisk Investigational Site	Staten Island	New York
United States	Novo Nordisk Investigational Site	Sugar Land	Texas
United States	Novo Nordisk Investigational Site	Toms River	New Jersey
United States	Novo Nordisk Investigational Site	Ventura	California
United States	Novo Nordisk Investigational Site	Waterbury	Connecticut
United States	Novo Nordisk Investigational Site	Wenatchee	Washington
United States	Novo Nordisk Investigational Site	West Seneca	New York
United States	Novo Nordisk Investigational Site	Whiteville	North Carolina
United States	Novo Nordisk Investigational Site	Wichita	Kansas
United States	Novo Nordisk Investigational Site	Wilmington	North Carolina
United States	Novo Nordisk Investigational Site	Winchester	Virginia
United States	Novo Nordisk Investigational Site	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Denmark,  Germany,  India,  Israel,  Italy,  Malaysia,  Mexico,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

References & Publications (6)

Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar 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 tri — View Citation

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. — View Citation

Leiter LA, Bain SC, Hramiak I, Jódar 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 th — View Citation

Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 — View Citation

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. — View Citation

Vilsbøll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simó 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Clinical Trials at Novo Nordisk