A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
NCT ID: NCT03078478
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1609 participants
INTERVENTIONAL
2017-03-13
2019-03-04
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
NONE
Study Groups
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IDeg 200 U/mL
Insulin degludec
For subcutaneous (s.c., under the skin) injection once daily
IGlar 300 U/mL
Insulin glargine
For subcutaneous (s.c., under the skin) injection once daily
Interventions
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Insulin degludec
For subcutaneous (s.c., under the skin) injection once daily
Insulin glargine
For subcutaneous (s.c., under the skin) injection once daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Chandler, Arizona, United States
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Fountain Hills, Arizona, United States
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Glendale, Arizona, United States
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Glendale, Arizona, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Buena Park, California, United States
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Concord, California, United States
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Downey, California, United States
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Duarte, California, United States
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Fresno, California, United States
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La Jolla, California, United States
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Lancaster, California, United States
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Lomita, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Moreno Valley, California, United States
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Northridge, California, United States
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Palm Springs, California, United States
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Pomona, California, United States
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Poway, California, United States
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Riverside, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Mateo, California, United States
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San Ramon, California, United States
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Stanford, California, United States
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Vista, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Colorado Springs, Colorado, United States
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Englewood, Colorado, United States
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Waterbury, Connecticut, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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Cooper City, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami Springs, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Palm Harbor, Florida, United States
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Pembroke Pines, Florida, United States
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Port Charlotte, Florida, United States
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Tampa, Florida, United States
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Marietta, Georgia, United States
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Roswell, Georgia, United States
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Honolulu, Hawaii, United States
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Blackfoot, Idaho, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Peoria, Illinois, United States
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Skokie, Illinois, United States
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Springfield, Illinois, United States
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Wauconda, Illinois, United States
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Evansville, Indiana, United States
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Mishawaka, Indiana, United States
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Valparaiso, Indiana, United States
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Council Bluffs, Iowa, United States
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West Des Moines, Iowa, United States
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Topeka, Kansas, 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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Paducah, Kentucky, United States
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New Orleans, Louisiana, United States
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Rockville, Maryland, United States
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Bloomfield Hills, Michigan, United States
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Richfield, Minnesota, United States
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Chesterfield, Missouri, United States
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Kalispell, Montana, United States
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Elkhorn, Nebraska, United States
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Fremont, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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East Brunswick, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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Northport, 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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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Greenville, North Carolina, United States
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Morehead City, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Columbus, Ohio, United States
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Columbus, 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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Beaver, Pennsylvania, United States
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McMurray, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Anderson, South Carolina, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Pelzer, South Carolina, United States
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West Columbia, South Carolina, United States
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Dakota Dunes, South Dakota, United States
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Bristol, Tennessee, 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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Amarillo, Texas, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Kerrville, Texas, United States
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New Braunfels, Texas, United States
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Plano, 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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San Antonio, 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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Bountiful, Utah, United States
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Murray, Utah, United States
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Ogden, Utah, United States
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Bennington, Vermont, United States
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Chesapeake, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Kenosha, Wisconsin, United States
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West Allis, Wisconsin, United States
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Calgary, Alberta, Canada
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Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Hamilton, Ontario, Canada
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Markham, Ontario, Canada
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Oakville, Ontario, Canada
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Toronto, Ontario, Canada
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Mirabel, Quebec, Canada
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Sherbrooke, 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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Hillerød, , Denmark
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Hvidovre, , Denmark
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Odense, , Denmark
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Viljandi, , Estonia
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Bad Mergentheim, , Germany
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Berlin, , Germany
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Elsterwerda, , Germany
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Essen, , 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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Hamburg, , Germany
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Lingen, , Germany
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Rehlingen-Siersburg, , Germany
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Saint Ingbert-Oberwürzbach, , Germany
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Athens, , Greece
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Athens, , Greece
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Larissa, , Greece
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Nikaia, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Debrecen, , Hungary
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Kaposvár, , Hungary
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Szeged, , Hungary
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Szombathely, , Hungary
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Hamar, , Norway
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Hoenefoss, , Norway
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Oslo, , Norway
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Oslo, , Norway
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Oslo, , Norway
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Skedsmokorset, , Norway
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Trondheim, , Norway
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Bialystok, , Poland
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Bytom, , Poland
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Gdansk, , Poland
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Gdansk, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Zabrze, , Poland
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Manatí, , Puerto Rico
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Ponce, , Puerto Rico
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Oradea, Bihor County, Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Buzău, , Romania
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Galati, , Romania
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Belgrade, , Serbia
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Belgrade, , Serbia
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Niš, , Serbia
Countries
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References
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Philis-Tsimikas A, Stratton I, Norgard Troelsen L, Anker Bak B, Leiter LA. Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478). J Diabetes Sci Technol. 2019 May;13(3):498-506. doi: 10.1177/1932296819841585. Epub 2019 Apr 11.
Philis-Tsimikas A, Klonoff DC, Khunti K, Bajaj HS, Leiter LA, Hansen MV, Troelsen LN, Ladelund S, Heller S, Pieber TR; CONCLUDE Study Group. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. Diabetologia. 2020 Apr;63(4):698-710. doi: 10.1007/s00125-019-05080-9. Epub 2020 Jan 27.
Evans M, Moes RGJ, Pedersen KS, Gundgaard J, Pieber TR. Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial. Adv Ther. 2020 May;37(5):2413-2426. doi: 10.1007/s12325-020-01332-y. Epub 2020 Apr 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1184-8175
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002801-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-4252
Identifier Type: -
Identifier Source: org_study_id
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