A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

NCT ID: NCT02692716

Last Updated: 2022-07-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-17

Study Completion Date

2018-09-25

Brief Summary

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This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oral semaglutide

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

For oral use once daily.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

For oral use once daily.

Interventions

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semaglutide

For oral use once daily.

Intervention Type DRUG

placebo

For oral use once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female diagnosed with type 2 diabetes
* Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor

Exclusion Criteria

* Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
* Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m\^2)
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

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Searcy, Arkansas, United States

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Concord, California, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Lancaster, California, United States

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Monterey, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Ventura, California, United States

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Boca Raton, Florida, United States

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New Port Richey, Florida, United States

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Roswell, Georgia, United States

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Savannah, Georgia, United States

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Honolulu, Hawaii, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

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Michigan City, Indiana, United States

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Muncie, Indiana, United States

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Council Bluffs, Iowa, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Monroe, Louisiana, United States

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Slidell, Louisiana, United States

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Canton, Michigan, United States

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Troy, Michigan, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Albany, New York, United States

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Albany, New York, United States

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North Massapequa, New York, United States

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Westfield, New York, United States

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Asheville, North Carolina, United States

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Greenville, North Carolina, United States

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Wilmington, North Carolina, United States

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Fargo, North Dakota, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Maumee, Ohio, United States

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Beaver, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Anderson, South Carolina, United States

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Moncks Corner, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Spartanburg, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Hurst, Texas, United States

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Midland, Texas, United States

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Round Rock, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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South Burlington, Vermont, United States

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Norfolk, Virginia, United States

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Winchester, Virginia, United States

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Annaba, , Algeria

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Oran, , Algeria

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Sétif, , Algeria

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Tizi Ouzou, , Algeria

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Buenos Aires, , Argentina

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CABA, , Argentina

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CABA, , Argentina

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CABA, , Argentina

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Córdoba, , Argentina

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Lanús Este, , Argentina

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Curitiba, Paraná, Brazil

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Mogi das Cruzes, São Paulo, Brazil

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São José dos Campos, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Brampton, Ontario, Canada

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Concord, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Aarhus N, , Denmark

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Esbjerg, , Denmark

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Hellerup, , Denmark

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Hvidovre, , Denmark

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Odense, , Denmark

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Bochum, , Germany

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Dresden, , Germany

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Elsterwerda, , Germany

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Essen, , Germany

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Falkensee, , Germany

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Hamburg, , Germany

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Ludwigshafen, , Germany

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Münster, , Germany

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Oldenburg, , Germany

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Oldenburg I. Holst, , Germany

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Rehlingen-Siersburg, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Hyderabad, Andhra Pradesh, India

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Hyderbad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Ahmedabad, Gujarat, India

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Kochi, Kerala, India

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Kozhikode, Kerala, India

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Thiruvananthapuram, Kerala, India

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Goa, Maharashtra, India

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Mumbai, Maharashtra, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Pune, Maharashtra, India

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New Dehli, New Delhi, India

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Ludhiana, Punjab, India

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Chennai, Tamil Nadu, India

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Kolkata, West Bengal, India

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New Delhi, , India

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New Delhi, , India

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Pune, , India

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Nahariya, , Israel

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Petah Tikva, , Israel

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Rishon LeZiyyon, , Israel

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Tel Aviv, , Israel

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Tel Aviv, , Israel

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Bergamo, , Italy

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Catanzaro, , Italy

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Chieti, , Italy

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Milan, , Italy

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Palermo, , Italy

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Roma, , Italy

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Roma, , Italy

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Ipoh, Perak, , Malaysia

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Kota Bharu, , Malaysia

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Kota Bharu, Kelantan, , Malaysia

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Kota Samarahan, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuching, , Malaysia

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Malacca, , Malaysia

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Putrajaya, , Malaysia

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Seremban, , Malaysia

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Mérida, Yucatán, Mexico

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San Luis Potosí City, , Mexico

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Almere Stad, , Netherlands

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Amsterdam, , Netherlands

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Eindhoven, , Netherlands

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Hoogeveen, , Netherlands

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Nijmegen, , Netherlands

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Krakow, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Oradea, Bihor County, Romania

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Târgu Mureş, Mureș County, Romania

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Bucharest, , Romania

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Galati, , Romania

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Lenasia, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Middleburg, Mpumalanga, South Africa

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Cape Town, Western Cape, South Africa

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Alcalá de Henares, , Spain

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Badalona, , Spain

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Fuenlabrada - Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Pontevedra, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Klong Luang, Pathumthani, , Thailand

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Nakhon Ratchasima, , Thailand

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Ankara, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Aydin, , Turkey (Türkiye)

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Denizli, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Rize, , Turkey (Türkiye)

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Aberdeen, , United Kingdom

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Bristol, , United Kingdom

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Dundee, , United Kingdom

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Edinburgh, , United Kingdom

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Exeter, , United Kingdom

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Guildford, , United Kingdom

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Norfolk, , United Kingdom

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Swansea, , United Kingdom

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Watford, , United Kingdom

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Countries

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United States Algeria Argentina Brazil Canada Denmark Germany India Israel Italy Malaysia Mexico Netherlands Poland Romania South Africa Spain Taiwan Thailand Turkey (Türkiye) United Kingdom

References

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Cefalu WT, Kaul S, Gerstein HC, Holman RR, Zinman B, Skyler JS, Green JB, Buse JB, Inzucchi SE, Leiter LA, Raz I, Rosenstock J, Riddle MC. Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum. Diabetes Care. 2018 Jan;41(1):14-31. doi: 10.2337/dci17-0057.

Reference Type RESULT
PMID: 29263194 (View on PubMed)

Bain SC, Mosenzon O, Arechavaleta R, Bogdanski P, Comlekci A, Consoli A, Deerochanawong C, Dungan K, Faingold MC, Farkouh ME, Franco DR, Gram J, Guja C, Joshi P, Malek R, Merino-Torres JF, Nauck MA, Pedersen SD, Sheu WH, Silver RJ, Tack CJ, Tandon N, Jeppesen OK, Strange M, Thomsen M, Husain M. Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial. Diabetes Obes Metab. 2019 Mar;21(3):499-508. doi: 10.1111/dom.13553. Epub 2018 Nov 11.

Reference Type RESULT
PMID: 30284349 (View on PubMed)

Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, Jeppesen OK, Lingvay I, Mosenzon O, Pedersen SD, Tack CJ, Thomsen M, Vilsboll T, Warren ML, Bain SC; PIONEER 6 Investigators. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2019 Aug 29;381(9):841-851. doi: 10.1056/NEJMoa1901118. Epub 2019 Jun 11.

Reference Type RESULT
PMID: 31185157 (View on PubMed)

Evans LM, Mellbin L, Johansen P, Lawson J, Paine A, Sandberg A. A population-adjusted indirect comparison of cardiovascular benefits of once-weekly subcutaneous semaglutide and dulaglutide in the treatment of patients with type 2 diabetes, with or without established cardiovascular disease. Endocrinol Diabetes Metab. 2021 May 15;4(3):e00259. doi: 10.1002/edm2.259. eCollection 2021 Jul.

Reference Type RESULT
PMID: 34277983 (View on PubMed)

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.

Reference Type RESULT
PMID: 35484580 (View on PubMed)

Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9.

Reference Type RESULT
PMID: 35373893 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39963952 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39520501 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37620807 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35582947 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33606902 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32998732 (View on PubMed)

Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

Reference Type DERIVED
PMID: 32267058 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31903692 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

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Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2015-003563-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1173-0750

Identifier Type: OTHER

Identifier Source: secondary_id

NL56580.091.16

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4221

Identifier Type: -

Identifier Source: org_study_id

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