Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
NCT ID: NCT01831765
Last Updated: 2019-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1290 participants
INTERVENTIONAL
2013-08-26
2015-06-11
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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Meal time FIAsp and insulin detemir
Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Meal time insulin aspart and insulin detemir
insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted.
Post meal FIAsp and insulin detemir
insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.
Interventions
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Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted.
Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.
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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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
Mobile, Alabama, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Concord, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Inglewood, 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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Long Beach, California, United States
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North Hollywood, California, United States
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Northridge, California, United States
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Poway, California, United States
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San Diego, California, United States
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Santa Barbara, California, United States
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Santa Barbara, California, United States
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Ventura, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Newark, Delaware, United States
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Boca Raton, Florida, United States
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Coral Gables, Florida, United States
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Fleming Island, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Sanford, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Dunwoody, Georgia, United States
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Lawrenceville, Georgia, United States
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Roswell, Georgia, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Nampa, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Crystal Lake, Illinois, United States
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Springfield, Illinois, United States
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Muncie, Indiana, United States
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Lenexa, Kansas, 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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Portland, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Hyattsville, Maryland, United States
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Rockville, Maryland, United States
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Waltham, Massachusetts, United States
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Worcester, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Eagan, Minnesota, United States
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Minneapolis, Minnesota, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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Butte, Montana, 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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Nashua, New Hampshire, United States
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Hoboken, New Jersey, United States
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Jersey City, 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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Albuquerque, New Mexico, United States
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Albany, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Smithtown, New York, United States
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Staten Island, New York, United States
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Staten Island, New York, United States
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Chapel Hill, 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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Columbus, Ohio, United States
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Mentor, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Jenkintown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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Sugar Land, Texas, United States
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Magna, Utah, 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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Spokane, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Bonheiden, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Québec, , Canada
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Helsinki, , Finland
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Kerava, , Finland
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Lappeenranta, , Finland
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Raisio, , Finland
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Tampere, , Finland
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Turku, , Finland
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Bad Mergentheim, , Germany
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Berlin, , Germany
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Damme, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Elsterwerda, , Germany
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Falkensee, , Germany
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Friedrichsthal, , Germany
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Fulda, , Germany
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Hamburg, , Germany
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Hohenmölsen, , Germany
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Lingen, , Germany
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Ludwigshafen, , Germany
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Münster, , Germany
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Münster, , Germany
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Neuwied, , Germany
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Oldenburg, , Germany
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Rehburg-Loccum, , Germany
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Rehlingen-Siersburg, , Germany
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Rostock, , Germany
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Saint Ingbert-Oberwürzbach, , Germany
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Schweinfurt, , Germany
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Völklingen, , Germany
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Wangen, , Germany
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Zwenkau, , Germany
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Budapest, , Hungary
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Budapest, , 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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Bialystok, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Bath, , United Kingdom
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Gillingham, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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Inverness, , United Kingdom
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Inverness, , United Kingdom
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Ipswich, , United Kingdom
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Nottingham, , United Kingdom
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Portsmouth, , United Kingdom
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Sheffield, , United Kingdom
Countries
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References
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Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.
Russell-Jones D, Bode BW, De Block C, Franek E, Heller SR, Mathieu C, Philis-Tsimikas A, Rose L, Woo VC, Osterskov AB, Graungaard T, Bergenstal RM. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017 Jul;40(7):943-950. doi: 10.2337/dc16-1771. Epub 2017 Mar 29.
Mathieu C, Bode BW, Franek E, Philis-Tsimikas A, Rose L, Graungaard T, Birk Osterskov A, Russell-Jones D. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018 May;20(5):1148-1155. doi: 10.1111/dom.13205. Epub 2018 Feb 4.
Bode BW, Bowering K, Russell-Jones D. Response to Comment on Russell-Jones et al. Diabetes Care 2017;40:943-950. Comment on Bowering et al. Diabetes Care 2017;40:951-957. Diabetes Care. 2018 Mar;41(3):e29-e30. doi: 10.2337/dci17-0051. No abstract available.
Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2010-024049-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1118-2442
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-3852
Identifier Type: -
Identifier Source: org_study_id
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