Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
NCT ID: NCT02607865
Last Updated: 2022-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1864 participants
INTERVENTIONAL
2016-02-15
2018-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Semaglutide 3 mg
semaglutide
Oral administration once-daily
placebo
Oral administration once-daily
Semaglutide 7 mg
semaglutide
Oral administration once-daily
placebo
Oral administration once-daily
Semaglutide 14 mg
semaglutide
Oral administration once-daily
placebo
Oral administration once-daily
Sitagliptin 100 mg
sitagliptin
Oral administration once-daily
placebo
Oral administration once-daily
Interventions
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semaglutide
Oral administration once-daily
sitagliptin
Oral administration once-daily
placebo
Oral administration once-daily
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening
* HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
* Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening
Exclusion Criteria
* 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)
* Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
* Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Tuscumbia, Alabama, United States
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Glendale, Arizona, United States
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Little Rock, Arkansas, United States
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Carmichael, California, United States
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Coronado, California, United States
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Encino, California, United States
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Fresno, California, United States
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Los Alamitos, California, United States
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Palm Springs, California, United States
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Poway, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Kissimmee, Florida, United States
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New Port Richey, Florida, United States
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Palm Harbor, Florida, United States
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Plantation, Florida, United States
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Port Charlotte, Florida, United States
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Spring Hill, Florida, United States
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Tampa, Florida, United States
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Marietta, Georgia, United States
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Perry, Georgia, United States
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Honolulu, Hawaii, United States
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Meridian, Idaho, United States
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Gurnee, Illinois, United States
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Peoria, Illinois, United States
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Peoria, Illinois, United States
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Avon, Indiana, United States
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Park City, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Paducah, Kentucky, United States
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Paducah, Kentucky, United States
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Metairie, Louisiana, United States
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Natchitoches, Louisiana, United States
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Shreveport, Louisiana, United States
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Rockville, Maryland, United States
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Waltham, Massachusetts, United States
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Flint, Michigan, United States
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Sterling Heights, Michigan, United States
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Jefferson City, Missouri, United States
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Butte, Montana, United States
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Teaneck, New Jersey, United States
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Trenton, New Jersey, United States
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Albuquerque, New Mexico, United States
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New Windsor, New York, United States
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Rochester, New York, United States
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West Seneca, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Statesville, North Carolina, United States
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Whiteville, 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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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Franklin, Ohio, United States
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Maumee, Ohio, United States
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Toledo, Ohio, United States
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Norman, Oklahoma, United States
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Corvallis, Oregon, United States
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Jersey Shore, Pennsylvania, United States
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McMurray, Pennsylvania, United States
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Gaffney, South Carolina, United States
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Greer, South Carolina, United States
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Pelzer, South Carolina, United States
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Summerville, South Carolina, United States
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Bristol, Tennessee, United States
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Humboldt, Tennessee, United States
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Jackson, Tennessee, United States
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Amarillo, Texas, United States
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Houston, Texas, United States
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Sugar Land, Texas, United States
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Murray, Utah, United States
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South Burlington, Vermont, United States
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Richmond, Virginia, United States
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Olympia, Washington, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Capital Federal, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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São Paulo, São Paulo, Brazil
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Angers, , France
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Châlons-en-Champagne, , France
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Dijon, , France
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La Roche-sur-Yon, , France
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La Rochelle, , France
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Le Creusot, , France
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Limoges, , France
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Marseille, , France
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Nanterre, , France
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Nantes, , France
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Nantes, , France
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Narbonne, , France
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Paris, , France
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Perpignan, , France
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Périgueux, , France
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Vénissieux, , France
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Bad Mergentheim, , Germany
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Berlin, , 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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Friedrichsthal, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Münster, , Germany
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Stuttgart, , Germany
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Hyderabad, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Gurgaon, Haryana, India
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Chennai, Tamil Nadu, India
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Vellore, Tamil Nadu, India
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Kolkata, West Bengal, India
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Kolkata, West Bengal, India
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Kolkata, West Bengal, India
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Raanana, , Israel
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Tel Aviv, , Israel
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Tel Aviv, , Israel
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Asahikawa-shi, Hokkaido, , Japan
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Gunma, , Japan
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Hokkaido, , Japan
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Ibaraki, , Japan
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Iruma-shi, Saitama, , Japan
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Kanagawa, , Japan
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Kashiwara-shi, Osaka, , Japan
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Kyoto-shi, Kyoto, , Japan
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Kyoto-shi, Kyoto, , Japan
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Miyazaki, , Japan
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Osaka, , Japan
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Shinjuku-ku, Tokyo, , Japan
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Shizuoka-shi, Shizuoka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Guadalajara, Jalisco, Mexico
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Toluca, State of Mexico, Mexico
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Ciudad Madero, Tamaulipas, Mexico
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Aguascalientes, , Mexico
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San Luis Potosí City, , Mexico
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Piteşti, Argeş, Romania
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Oradea, Bihor County, Romania
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Craiova, Dolj, Romania
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Baia Mare, Maramureş, Romania
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Târgu Mureş, Mureș County, Romania
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Ploieşti, Prahova, Romania
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Timișoara, Timiș County, Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Iași, , Romania
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Iași, , Romania
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Satu Mare, , Romania
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Timișoara, , Romania
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Barnaul, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Penza, , Russia
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Tomsk, , Russia
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Tomsk, , Russia
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Yaroslavl, , Russia
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Port Elizabeth, Eastern Cape, South Africa
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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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Johannesburg, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Krugersdorp, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Cape Town, , South Africa
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Pretoria, , South Africa
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , 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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Samsun, , Turkey (Türkiye)
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Cherkasy, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Mykolaiv, , Ukraine
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Odesa, , Ukraine
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Ternopil, , Ukraine
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Zaporizhia, , Ukraine
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Zhytomyr, , Ukraine
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Basingstoke, , United Kingdom
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Cardiff, , United Kingdom
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Chester, , United Kingdom
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Crewe, , United Kingdom
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Doncaster, , United Kingdom
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Leicester, , United Kingdom
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Plymouth, , United Kingdom
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Preston, , United Kingdom
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Rotherham, , United Kingdom
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Sidcup, , United Kingdom
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Soham, , United Kingdom
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Swansea, , United Kingdom
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Taunton, , United Kingdom
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Torquay, , United Kingdom
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Wellingborough, , United Kingdom
Countries
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References
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Rosenstock J, Allison D, Birkenfeld AL, Blicher TM, Deenadayalan S, Jacobsen JB, Serusclat P, Violante R, Watada H, Davies M; PIONEER 3 Investigators. Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1466-1480. doi: 10.1001/jama.2019.2942.
Araki E, Terauchi Y, Watada H, Deenadayalan S, Christiansen E, Horio H, Kadowaki T. Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials. Diabetes Obes Metab. 2021 Dec;23(12):2785-2794. doi: 10.1111/dom.14536. Epub 2021 Sep 27.
Eliasson B, Ericsson A, Fridhammar A, Nilsson A, Persson S, Chubb B. Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting. Pharmacoecon Open. 2022 May;6(3):343-354. doi: 10.1007/s41669-021-00317-z. Epub 2022 Jan 21.
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.
Pulleyblank R, Larsen NB. Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study. Pharmacoecon Open. 2023 Jul;7(4):579-591. doi: 10.1007/s41669-023-00416-z. Epub 2023 May 13.
Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2015-001351-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1168-4339
Identifier Type: OTHER
Identifier Source: secondary_id
JAPIC
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-4222
Identifier Type: -
Identifier Source: org_study_id
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