Diabetes Mellitus, Type 2 Clinical Trial
— DEVOTEOfficial title:
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
| Verified date | July 2019 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.
| Status | Completed |
| Enrollment | 7637 |
| Est. completion date | October 16, 2016 |
| Est. primary completion date | October 16, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) |
| Country | Name | City | State |
|---|---|---|---|
| Algeria | Novo Nordisk Investigational Site | Algiers | |
| Algeria | Novo Nordisk Investigational Site | Constantine | |
| Algeria | Novo Nordisk Investigational Site | Oran | |
| Algeria | Novo Nordisk Investigational Site | Sidi Bel Abbes | |
| 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 | Rosario | |
| Argentina | Novo Nordisk Investigational Site | Zarate | |
| Brazil | Novo Nordisk Investigational Site | Aparecida de Goiania | Goias |
| Brazil | Novo Nordisk Investigational Site | Belém | Para |
| Brazil | Novo Nordisk Investigational Site | Brasília | Distrito Federal |
| Brazil | Novo Nordisk Investigational Site | Fortaleza | |
| Brazil | Novo Nordisk Investigational Site | Fortaleza | Ceara |
| Brazil | Novo Nordisk Investigational Site | Mogi das Cruzes | Sao Paulo |
| 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 |
| Canada | Novo Nordisk Investigational Site | Chatham | Ontario |
| Canada | Novo Nordisk Investigational Site | Edmonton | Alberta |
| Canada | Novo Nordisk Investigational Site | Laval | Quebec |
| Canada | Novo Nordisk Investigational Site | Ottawa | Ontario |
| Canada | Novo Nordisk Investigational Site | Sarnia | Ontario |
| Canada | Novo Nordisk Investigational Site | Winnipeg | Manitoba |
| Croatia | Novo Nordisk Investigational Site | Bjelovar | |
| Croatia | Novo Nordisk Investigational Site | Osijek | |
| Croatia | Novo Nordisk Investigational Site | Slavonski Brod | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Thessaloniki | |
| Greece | Novo Nordisk Investigational Site | Thessaloniki | |
| India | Novo Nordisk Investigational Site | Ahmedabad | Gujarat |
| India | Novo Nordisk Investigational Site | Ahmedabad | Gujarat |
| India | Novo Nordisk Investigational Site | Ahmedabad | Gujarat |
| India | Novo Nordisk Investigational Site | Ahmedabad | Gujarat |
| India | Novo Nordisk Investigational Site | Bangalore | Karnataka |
| India | Novo Nordisk Investigational Site | Bangalore | Karnataka |
| India | Novo Nordisk Investigational Site | Bhubaneswar | Orissa |
| India | Novo Nordisk Investigational Site | Chennai | Tamil Nadu |
| India | Novo Nordisk Investigational Site | Chennai | Tamil Nadu |
| India | Novo Nordisk Investigational Site | Coimbatore | Tamil Nadu |
| India | Novo Nordisk Investigational Site | Goa | Maharashtra |
| India | Novo Nordisk Investigational Site | Gurgaon | Haryana |
| India | Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh |
| India | Novo Nordisk Investigational Site | Hyderbad | Andhra Pradesh |
| India | Novo Nordisk Investigational Site | Indore | Madhya Pradesh |
| India | Novo Nordisk Investigational Site | Kolkata | West Bengal |
| India | Novo Nordisk Investigational Site | Kolkata | West Bengal |
| India | Novo Nordisk Investigational Site | Kozhikode | Kerala |
| India | Novo Nordisk Investigational Site | Lucknow | Uttar Pradesh |
| India | Novo Nordisk Investigational Site | Ludhiana | |
| India | Novo Nordisk Investigational Site | Mohali | Punjab |
| 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 | New Dehli | New Delhi |
| India | Novo Nordisk Investigational Site | New Delhi | |
| India | Novo Nordisk Investigational Site | Pune | Maharashtra |
| India | Novo Nordisk Investigational Site | Pune | Maharashtra |
| Italy | Novo Nordisk Investigational Site | Bari | |
| Italy | Novo Nordisk Investigational Site | Bergamo | |
| Italy | Novo Nordisk Investigational Site | Catanzaro | |
| Italy | Novo Nordisk Investigational Site | Chieti | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Milano (MI) | |
| Italy | Novo Nordisk Investigational Site | Olbia | |
| Italy | Novo Nordisk Investigational Site | Padova | |
| Italy | Novo Nordisk Investigational Site | Palermo | |
| Italy | Novo Nordisk Investigational Site | Ravenna | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Sesto San Giovanni (MI) | |
| Japan | Novo Nordisk Investigational Site | Chuo-ku, Tokyo | |
| Japan | Novo Nordisk Investigational Site | Kanagawa | |
| Japan | Novo Nordisk Investigational Site | Kumamoto | |
| Japan | Novo Nordisk Investigational Site | Miyazaki | |
| Japan | Novo Nordisk Investigational Site | Nagano | |
| Japan | Novo Nordisk Investigational Site | Ota-ku | |
| Japan | Novo Nordisk Investigational Site | Ota-ku, Tokyo | |
| Japan | Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | |
| Korea, Republic of | Novo Nordisk Investigational Site | Goyang | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Suwon-si, Gyeonggi-do | |
| Malaysia | Novo Nordisk Investigational Site | Alor Setar | |
| Malaysia | Novo Nordisk Investigational Site | Kota Samarahan | |
| Malaysia | Novo Nordisk Investigational Site | Kuala Lumpur | |
| Malaysia | Novo Nordisk Investigational Site | Kuantan | |
| 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 | Chihuahua | |
| Mexico | Novo Nordisk Investigational Site | Cuernavaca | Morelos |
| Mexico | Novo Nordisk Investigational Site | Distrito Federal | México, D.F. |
| 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 | Guadalajara | Jalisco |
| Mexico | Novo Nordisk Investigational Site | Guadalajara | Jalisco |
| Mexico | Novo Nordisk Investigational Site | San Luis Potosi | |
| Poland | Novo Nordisk Investigational Site | Bytom | |
| Poland | Novo Nordisk Investigational Site | Gdansk | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Oswiecim | |
| Poland | Novo Nordisk Investigational Site | Poznan | |
| Poland | Novo Nordisk Investigational Site | Szczecin | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Poland | Novo Nordisk Investigational Site | Zamosc | |
| Romania | Novo Nordisk Investigational Site | Alba Iulia | Alba |
| Romania | Novo Nordisk Investigational Site | Baia Mare | Maramures |
| Romania | Novo Nordisk Investigational Site | Ploiesti | Prahova |
| Romania | Novo Nordisk Investigational Site | Targu Mures | Mures |
| Russian Federation | Novo Nordisk Investigational Site | Ekaterinburg | |
| Russian Federation | Novo Nordisk Investigational Site | Kemerovo | |
| Russian Federation | Novo Nordisk Investigational Site | Kirov | |
| Russian Federation | Novo Nordisk Investigational Site | Krasnodar | |
| Russian Federation | Novo Nordisk Investigational Site | Krasnodar | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Nizhny Novgorod | |
| Russian Federation | Novo Nordisk Investigational Site | Rostov-on-Don | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| 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 | St. Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | St. Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Syktyvkar | |
| Russian Federation | Novo Nordisk Investigational Site | Tumen | |
| Russian Federation | Novo Nordisk Investigational Site | Tver | |
| Russian Federation | Novo Nordisk Investigational Site | Ulianovsk | |
| Russian Federation | Novo Nordisk Investigational Site | Volgograd | |
| Russian Federation | Novo Nordisk Investigational Site | Yaroslavl | |
| South Africa | Novo Nordisk Investigational Site | Brits | North West |
| South Africa | Novo Nordisk Investigational Site | Cape Town | Western Cape |
| South Africa | Novo Nordisk Investigational Site | Cape Town | Western Cape |
| South Africa | Novo Nordisk Investigational Site | Cape Town | Western Cape |
| South Africa | Novo Nordisk Investigational Site | Cape Town | Western Cape |
| South Africa | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal |
| South Africa | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Middleburg | Mpumalanga |
| South Africa | Novo Nordisk Investigational Site | Port Elizabeth | Eastern Cape |
| South Africa | Novo Nordisk Investigational Site | Port Elizabeth | Eastern Cape |
| South Africa | Novo Nordisk Investigational Site | Pretoria | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Umkomaas | KwaZulu-Natal |
| Spain | Novo Nordisk Investigational Site | Granada | |
| Spain | Novo Nordisk Investigational Site | Granada | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Málaga | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Spain | Novo Nordisk Investigational Site | Valencia | |
| Spain | Novo Nordisk Investigational Site | Valencia | |
| Thailand | Novo Nordisk Investigational Site | Bangkok | |
| Thailand | Novo Nordisk Investigational Site | Bangkok | |
| Thailand | Novo Nordisk Investigational Site | Bangkoknoi, Bangkok | |
| Thailand | Novo Nordisk Investigational Site | Chiang Mai | |
| Thailand | Novo Nordisk Investigational Site | Nakhon Ratchasima | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Dundee | |
| United Kingdom | Novo Nordisk Investigational Site | Edinburgh | |
| United Kingdom | Novo Nordisk Investigational Site | Guildford | |
| United Kingdom | Novo Nordisk Investigational Site | Norwich | |
| United Kingdom | Novo Nordisk Investigational Site | Nuneaton | |
| United Kingdom | Novo Nordisk Investigational Site | Stevenage | |
| United Kingdom | Novo Nordisk Investigational Site | Wolverhampton | |
| United States | Novo Nordisk Investigational Site | Addison | Illinois |
| United States | Novo Nordisk Investigational Site | Albany | New York |
| United States | Novo Nordisk Investigational Site | Altoona | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Anderson | South Carolina |
| United States | Novo Nordisk Investigational Site | Ann Arbor | Michigan |
| United States | Novo Nordisk Investigational Site | Ann Arbor | Michigan |
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Asheville | North Carolina |
| United States | Novo Nordisk Investigational Site | Asheville | North Carolina |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Bangor | Maine |
| United States | Novo Nordisk Investigational Site | Beaver | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Bennington | Vermont |
| United States | Novo Nordisk Investigational Site | Billings | Montana |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Boca Raton | Florida |
| United States | Novo Nordisk Investigational Site | Boynton Beach | Florida |
| United States | Novo Nordisk Investigational Site | Bradenton | Florida |
| United States | Novo Nordisk Investigational Site | Brandon | Florida |
| United States | Novo Nordisk Investigational Site | Brownsburg | Indiana |
| United States | Novo Nordisk Investigational Site | Buckley | Michigan |
| United States | Novo Nordisk Investigational Site | Burlington | North Carolina |
| United States | Novo Nordisk Investigational Site | Carrollton | Texas |
| United States | Novo Nordisk Investigational Site | Carrollton | Texas |
| United States | Novo Nordisk Investigational Site | Cary | North Carolina |
| United States | Novo Nordisk Investigational Site | Champaign | Illinois |
| United States | Novo Nordisk Investigational Site | Chapel Hill | North Carolina |
| United States | Novo Nordisk Investigational Site | Charlotte | North Carolina |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chula Vista | California |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Clearwater | Florida |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
| United States | Novo Nordisk Investigational Site | Columbus | Ohio |
| United States | Novo Nordisk Investigational Site | Concord | California |
| United States | Novo Nordisk Investigational Site | Cooper City | Florida |
| United States | Novo Nordisk Investigational Site | Corpus Christi | Texas |
| United States | Novo Nordisk Investigational Site | Council Bluffs | Iowa |
| United States | Novo Nordisk Investigational Site | Crystal Lake | Illinois |
| 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 | Danbury | Connecticut |
| United States | Novo Nordisk Investigational Site | Danville | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Decatur | Georgia |
| United States | Novo Nordisk Investigational Site | Delaware | Ohio |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | Downey | California |
| United States | Novo Nordisk Investigational Site | Duarte | California |
| United States | Novo Nordisk Investigational Site | Dunwoody | Georgia |
| United States | Novo Nordisk Investigational Site | East Brunswick | New Jersey |
| United States | Novo Nordisk Investigational Site | Elkhorn | Nebraska |
| United States | Novo Nordisk Investigational Site | Encino | California |
| United States | Novo Nordisk Investigational Site | Evansville | Indiana |
| United States | Novo Nordisk Investigational Site | Fargo | North Dakota |
| United States | Novo Nordisk Investigational Site | Fleming Island | Florida |
| United States | Novo Nordisk Investigational Site | Fort Lauderdale | Florida |
| United States | Novo Nordisk Investigational Site | Fort Worth | Texas |
| United States | Novo Nordisk Investigational Site | Fort Worth | Texas |
| United States | Novo Nordisk Investigational Site | Franklin | Indiana |
| United States | Novo Nordisk Investigational Site | Franklin | Ohio |
| United States | Novo Nordisk Investigational Site | Fremont | Nebraska |
| United States | Novo Nordisk Investigational Site | Fresno | California |
| United States | Novo Nordisk Investigational Site | Gainesville | Florida |
| United States | Novo Nordisk Investigational Site | Gilbert | Arizona |
| United States | Novo Nordisk Investigational Site | Glendale | Arizona |
| United States | Novo Nordisk Investigational Site | Golden | Colorado |
| United States | Novo Nordisk Investigational Site | Green Cove Springs | Florida |
| United States | Novo Nordisk Investigational Site | Greenbrae | California |
| United States | Novo Nordisk Investigational Site | Greenfield | Indiana |
| 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 | Hazelwood | Missouri |
| United States | Novo Nordisk Investigational Site | Hermitage | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Hialeah | Florida |
| United States | Novo Nordisk Investigational Site | Hines | Illinois |
| United States | Novo Nordisk Investigational Site | Hoboken | New Jersey |
| United States | Novo Nordisk Investigational Site | Honolulu | Hawaii |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Humble | Texas |
| United States | Novo Nordisk Investigational Site | Huntington Beach | California |
| United States | Novo Nordisk Investigational Site | Hurst | Texas |
| United States | Novo Nordisk Investigational Site | Hyattsville | Maryland |
| United States | Novo Nordisk Investigational Site | Idaho Falls | Idaho |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Inglewood | California |
| United States | Novo Nordisk Investigational Site | Irving | Texas |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jefferson City | Missouri |
| United States | Novo Nordisk Investigational Site | Kalamazoo | Michigan |
| United States | Novo Nordisk Investigational Site | Kalispell | Montana |
| United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
| United States | Novo Nordisk Investigational Site | Kenosha | Wisconsin |
| United States | Novo Nordisk Investigational Site | Kingsport | Tennessee |
| United States | Novo Nordisk Investigational Site | Knoxville | Tennessee |
| United States | Novo Nordisk Investigational Site | La Jolla | California |
| United States | Novo Nordisk Investigational Site | La Mesa | California |
| United States | Novo Nordisk Investigational Site | Lake Success | New York |
| United States | Novo Nordisk Investigational Site | Lancaster | California |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lawrenceville | Georgia |
| United States | Novo Nordisk Investigational Site | Lewisville | Texas |
| United States | Novo Nordisk Investigational Site | Lexington | North Carolina |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Litchfield Park | Arizona |
| United States | Novo Nordisk Investigational Site | Little Rock | Arkansas |
| United States | Novo Nordisk Investigational Site | Little Rock | Arkansas |
| United States | Novo Nordisk Investigational Site | Livonia | Michigan |
| United States | Novo Nordisk Investigational Site | Long Beach | California |
| United States | Novo Nordisk Investigational Site | Longview | Texas |
| United States | Novo Nordisk Investigational Site | Los Alamitos | California |
| United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
| United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
| United States | Novo Nordisk Investigational Site | Lubbock | Texas |
| United States | Novo Nordisk Investigational Site | Madisonville | Kentucky |
| United States | Novo Nordisk Investigational Site | Maumee | Ohio |
| United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
| United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
| United States | Novo Nordisk Investigational Site | Mentor | Ohio |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Michigan City | Indiana |
| United States | Novo Nordisk Investigational Site | Midland | Texas |
| United States | Novo Nordisk Investigational Site | Midlothian | Virginia |
| United States | Novo Nordisk Investigational Site | Milwaukee | Wisconsin |
| United States | Novo Nordisk Investigational Site | Milwaukee | Wisconsin |
| United States | Novo Nordisk Investigational Site | Mineola | New York |
| United States | Novo Nordisk Investigational Site | Mission Hills | California |
| United States | Novo Nordisk Investigational Site | Moncks Corner | South Carolina |
| United States | Novo Nordisk Investigational Site | Monroe | Louisiana |
| United States | Novo Nordisk Investigational Site | Montclair | California |
| United States | Novo Nordisk Investigational Site | Monterey | California |
| United States | Novo Nordisk Investigational Site | Montgomery | Alabama |
| United States | Novo Nordisk Investigational Site | Montgomery | Alabama |
| United States | Novo Nordisk Investigational Site | Morehead City | North Carolina |
| United States | Novo Nordisk Investigational Site | Muncie | Indiana |
| United States | Novo Nordisk Investigational Site | Murrells Inlet | South Carolina |
| United States | Novo Nordisk Investigational Site | Myrtle Beach | South Carolina |
| United States | Novo Nordisk Investigational Site | Naples | Florida |
| United States | Novo Nordisk Investigational Site | Nashua | New Hampshire |
| United States | Novo Nordisk Investigational Site | Nashville | Tennessee |
| United States | Novo Nordisk Investigational Site | Nashville | Tennessee |
| United States | Novo Nordisk Investigational Site | Nashville | Tennessee |
| United States | Novo Nordisk Investigational Site | New Bern | North Carolina |
| United States | Novo Nordisk Investigational Site | New Orleans | Louisiana |
| United States | Novo Nordisk Investigational Site | New Port Richey | Florida |
| United States | Novo Nordisk Investigational Site | New Windsor | New York |
| United States | Novo Nordisk Investigational Site | New York | New York |
| United States | Novo Nordisk Investigational Site | Norfolk | Virginia |
| United States | Novo Nordisk Investigational Site | Norman | Oklahoma |
| United States | Novo Nordisk Investigational Site | North Hollywood | California |
| United States | Novo Nordisk Investigational Site | North Massapequa | New York |
| United States | Novo Nordisk Investigational Site | Northport | New York |
| United States | Novo Nordisk Investigational Site | Norwalk | Connecticut |
| United States | Novo Nordisk Investigational Site | Odessa | Texas |
| United States | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma |
| United States | Novo Nordisk Investigational Site | Olive Branch | Mississippi |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Orangeburg | South Carolina |
| United States | Novo Nordisk Investigational Site | Orlando | Florida |
| United States | Novo Nordisk Investigational Site | Palm Springs | California |
| United States | Novo Nordisk Investigational Site | Panama City | Florida |
| United States | Novo Nordisk Investigational Site | Pearland | Texas |
| United States | Novo Nordisk Investigational Site | Perrysburg | Ohio |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Ponte Vedra | Florida |
| United States | Novo Nordisk Investigational Site | Port Charlotte | Florida |
| United States | Novo Nordisk Investigational Site | Port Orange | Florida |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Poway | California |
| United States | Novo Nordisk Investigational Site | Richardson | Texas |
| United States | Novo Nordisk Investigational Site | Richland | Washington |
| United States | Novo Nordisk Investigational Site | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | Rochester | New York |
| United States | Novo Nordisk Investigational Site | Rockville | Maryland |
| United States | Novo Nordisk Investigational Site | Roswell | Georgia |
| United States | Novo Nordisk Investigational Site | Round Rock | Texas |
| United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
| 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 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 Diego | California |
| United States | Novo Nordisk Investigational Site | San Ramon | California |
| United States | Novo Nordisk Investigational Site | Santa Ana | California |
| United States | Novo Nordisk Investigational Site | Savannah | Georgia |
| United States | Novo Nordisk Investigational Site | Searcy | Arkansas |
| United States | Novo Nordisk Investigational Site | Sherman Oaks | California |
| United States | Novo Nordisk Investigational Site | Shreveport | Louisiana |
| United States | Novo Nordisk Investigational Site | Slidell | Louisiana |
| United States | Novo Nordisk Investigational Site | Smithfield | Pennsylvania |
| United States | Novo Nordisk Investigational Site | South Burlington | Vermont |
| United States | Novo Nordisk Investigational Site | South Miami | Florida |
| United States | Novo Nordisk Investigational Site | Spartanburg | South Carolina |
| United States | Novo Nordisk Investigational Site | Splendora | Texas |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | Statesville | North Carolina |
| United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
| United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Thousand Oaks | California |
| United States | Novo Nordisk Investigational Site | Troy | Michigan |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Tullahoma | Tennessee |
| United States | Novo Nordisk Investigational Site | Tustin | California |
| United States | Novo Nordisk Investigational Site | Uniontown | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Upper Darby | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Ventura | California |
| United States | Novo Nordisk Investigational Site | Vista | California |
| United States | Novo Nordisk Investigational Site | Waco | Texas |
| United States | Novo Nordisk Investigational Site | Waterbury | Connecticut |
| United States | Novo Nordisk Investigational Site | Watertown | Massachusetts |
| United States | Novo Nordisk Investigational Site | West Seneca | New York |
| United States | Novo Nordisk Investigational Site | Westfield | New York |
| United States | Novo Nordisk Investigational Site | Westminster | California |
| United States | Novo Nordisk Investigational Site | Whiteville | North Carolina |
| United States | Novo Nordisk Investigational Site | Wichita | Kansas |
| United States | Novo Nordisk Investigational Site | Wilkes-Barre | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Wilmington | North Carolina |
| United States | Novo Nordisk Investigational Site | Winchester | Virginia |
| United States | Novo Nordisk Investigational Site | Winston-Salem | North Carolina |
| United States | Novo Nordisk Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Algeria, Argentina, Brazil, Canada, Croatia, Greece, India, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Thailand, United Kingdom,
Brown-Frandsen K, Emerson SS, McGuire DK, Pieber TR, Poulter NR, Pratley RE, Zinman B, Ranthe MF, Grøn R, Lange M, Moses AC, Örsy P, Buse JB; DEVOTE Study Group. Lower rates of cardiovascular events and mortality associated with liraglutide use in patient — View Citation
Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Brown-Frandsen K, Moses A, Skibsted S, Kvist K, Buse JB; DEVOTE Study Group. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med — View Citation
Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Frandsen KB, Rabøl R, Buse JB. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabet — View Citation
Pieber TR, Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pratley RE, Woo V, Heller S, Lange M, Brown-Frandsen K, Moses A, Barner Lekdorf J, Lehmann L, Kvist K, Buse JB; DEVOTE Study Group. DEVOTE 3: temporal relationships between severe hypoglyc — View Citation
Pollock RF, Heller S, Pieber TR, Woo V, Gundgaard J, Hallén N, Luckevich M, Tutkunkardas D, Zinman B; DEVOTE Study Group. Short-term cost-utility of degludec versus glargine U100 for patients with type 2 diabetes at high risk of hypoglycaemia and cardiovascular events: A Canadian setting (DEVOTE 9). Diabetes Obes Metab. 2019 Jul;21(7):1706-1714. doi: 10.1111/dom.13730. Epub 2019 Apr 14. — View Citation
Pollock RF, Valentine WJ, Marso SP, Andersen A, Gundgaard J, Hallén N, Tutkunkardas D, Magnuson EA, Buse JB; DEVOTE study group. Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16). Appl Health Econ Health Policy. 2019 Jul 2. doi: 10.1007/s40258-019-00494-3. [Epub ahead of print] — View Citation
Pollock RF, Valentine WJ, Marso SP, Gundgaard J, Hallén N, Hansen LL, Tutkunkardas D, Buse JB; DEVOTE Study Group. DEVOTE 5: Evaluating the Short-Term Cost-Utility of Insulin Degludec Versus Insulin Glargine U100 in Basal-Bolus Regimens for Type 2 Diabete — View Citation
Pratley RE, Emerson SS, Franek E, Gilbert MP, Marso SP, McGuire DK, Pieber TR, Zinman B, Hansen CT, Hansen MV, Mark T, Moses AC, Buse JB; DEVOTE Study Group. Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine — View Citation
Theilgaard H, Mollerup I, Helmark IC, Endahl L, Hoskin S, Hvelplund A, Amby LK, Moses AC. Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degl — View Citation
Zinman B, Marso SP, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Lange M, Brown-Frandsen K, Moses A, Ocampo Francisco AM, Barner Lekdorf J, Kvist K, Buse JB; DEVOTE Study Group. Day-to-day fasting glycaemic variability in DEVOTE: associations with sever — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months. | From randomisation to individual end of trial date (maximum patient year observation: 2.75 years) | |
| Secondary | Number of EAC-confirmed Severe Hypoglycaemic Episodes | Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months. | From randomisation to individual end of trial (maximum patient year observation: 2.75 years) | |
| Secondary | Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no) | Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. | From randomisation to individual end of trial date (maximum patient year observation: 2.75 years) | |
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) | Mean change in HbA1c from week 0 to month 24. | Randomisation to 24 months |
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