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Clinical Trial Details

Trial ID: L3186
Source ID: NCT01831765
Associated Drug: Faster-Acting Insulin Aspart
Title: Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
Acronym: onset® 1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01831765/results
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: Faster-acting insulin aspart|DRUG: insulin detemir|DRUG: insulin aspart|DRUG: Faster-acting insulin aspart
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Change from baseline in HbA1c after 26 weeks of randomised treatment., Week 0, week 26 | Secondary: Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test), Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test)., Week 0, week 26|Change From Baseline in HbA1c (Post Meal Arm), Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment., Week 0, week 26|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes, Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia., From baseline until week 26|Change From Baseline in Body Weight, Change from baseline in body weight after 26 weeks of randomised treatment., Week 0, week 26|Frequency of Adverse Events, All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment., After 52 weeks of randomised treatment|Change in HbA1c, Change from baseline in HbA1c (%) after 52 weeks of randomised treatment., Week 0, week 52|Change in PPG (Postprandial Glucose), Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment., Week 0, week 52
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1290
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-08-26
Completion Date: 2015-06-11
Results First Posted: 2018-01-23
Last Update Posted: 2019-06-12
Locations: Novo Nordisk Investigational Site, Mobile, Alabama, 36608, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85714, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85724, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Fullerton, California, 92835, United States|Novo Nordisk Investigational Site, Inglewood, California, 90301, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, La Mesa, California, 91942, United States|Novo Nordisk Investigational Site, Long Beach, California, 90807, United States|Novo Nordisk Investigational Site, North Hollywood, California, 91606, United States|Novo Nordisk Investigational Site, Northridge, California, 91324, United States|Novo Nordisk Investigational Site, Poway, California, 92064, United States|Novo Nordisk Investigational Site, San Diego, California, 92037, United States|Novo Nordisk Investigational Site, Santa Barbara, California, 93105-4321, United States|Novo Nordisk Investigational Site, Santa Barbara, California, 93105, United States|Novo Nordisk Investigational Site, Ventura, California, 93003-2824, United States|Novo Nordisk Investigational Site, Ventura, California, 93003, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Denver, Colorado, 80209, United States|Novo Nordisk Investigational Site, Newark, Delaware, 19713, United States|Novo Nordisk Investigational Site, Boca Raton, Florida, 33433, United States|Novo Nordisk Investigational Site, Coral Gables, Florida, 33134, United States|Novo Nordisk Investigational Site, Fleming Island, Florida, 32203, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33308, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33312, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, United States|Novo Nordisk Investigational Site, Miami, Florida, 33015, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Miami, Florida, 33173, United States|Novo Nordisk Investigational Site, Miami, Florida, 33174, United States|Novo Nordisk Investigational Site, Sanford, Florida, 32771, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33614, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30339, United States|Novo Nordisk Investigational Site, Dunwoody, Georgia, 30338, United States|Novo Nordisk Investigational Site, Lawrenceville, Georgia, 30046, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Nampa, Idaho, 83686-6011, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60064, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Crystal Lake, Illinois, 60012, United States|Novo Nordisk Investigational Site, Springfield, Illinois, 62711, United States|Novo Nordisk Investigational Site, Muncie, Indiana, 47304, United States|Novo Nordisk Investigational Site, Lenexa, Kansas, 66219, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40502, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Portland, Maine, 04101, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21204, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21287, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Worcester, Massachusetts, 01655, United States|Novo Nordisk Investigational Site, Kalamazoo, Michigan, 49048, United States|Novo Nordisk Investigational Site, Eagan, Minnesota, 55123, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55416, United States|Novo Nordisk Investigational Site, Kansas City, Missouri, 64106, United States|Novo Nordisk Investigational Site, Springfield, Missouri, 65807, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68114, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052-2649, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89128, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89148, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Hoboken, New Jersey, 07030, United States|Novo Nordisk Investigational Site, Jersey City, New Jersey, 07306, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87106, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87109-2134, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87131, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, New York, New York, 10029, United States|Novo Nordisk Investigational Site, Rochester, New York, 14607, United States|Novo Nordisk Investigational Site, Smithtown, New York, 11787, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301-3901, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, Chapel Hill, North Carolina, 27517, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43201, United States|Novo Nordisk Investigational Site, Mentor, Ohio, 44060, United States|Novo Nordisk Investigational Site, Portland, Oregon, 97210, United States|Novo Nordisk Investigational Site, Portland, Oregon, 97239, United States|Novo Nordisk Investigational Site, Jenkintown, Pennsylvania, 19046-3638, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19140-5103, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19140, United States|Novo Nordisk Investigational Site, Greenville, South Carolina, 29605-4254, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Beaumont, Texas, 77701, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Houston, Texas, 77079, United States|Novo Nordisk Investigational Site, Houston, Texas, 77099, United States|Novo Nordisk Investigational Site, Lubbock, Texas, 79423, United States|Novo Nordisk Investigational Site, Plano, Texas, 75093, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77479, United States|Novo Nordisk Investigational Site, Magna, Utah, 84044, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99201, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99202-1334, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99202-3649, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99202, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99208, United States|Novo Nordisk Investigational Site, Bonheiden, 2820, Belgium|Novo Nordisk Investigational Site, Brussels, 1070, Belgium|Novo Nordisk Investigational Site, Edegem, 2650, Belgium|Novo Nordisk Investigational Site, Gent, 9000, Belgium|Novo Nordisk Investigational Site, Leuven, 3000, Belgium|Novo Nordisk Investigational Site, Edmonton, Alberta, T5J 3N4, Canada|Novo Nordisk Investigational Site, Edmonton, Alberta, T6G 2E1, Canada|Novo Nordisk Investigational Site, Victoria, British Columbia, V8R 1J8, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8N 3Z5, Canada|Novo Nordisk Investigational Site, London, Ontario, N6A 4V2, Canada|Novo Nordisk Investigational Site, London, Ontario, N6G 2M1, Canada|Novo Nordisk Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M5T 3L9, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H2W 1R7, Canada|Novo Nordisk Investigational Site, Sherbrooke, Quebec, J1G 5K2, Canada|Novo Nordisk Investigational Site, Quebec, G1V 4G2, Canada|Novo Nordisk Investigational Site, Brno, 65691, Czechia|Novo Nordisk Investigational Site, Hradec Kralove, 50005, Czechia|Novo Nordisk Investigational Site, Prague 4, 140 21, Czechia|Novo Nordisk Investigational Site, Praha 10, 100 00, Czechia|Novo Nordisk Investigational Site, Praha, 12808, Czechia|Novo Nordisk Investigational Site, Helsinki, 00260, Finland|Novo Nordisk Investigational Site, Kerava, FI-04200, Finland|Novo Nordisk Investigational Site, Lappeenranta, 53130, Finland|Novo Nordisk Investigational Site, Raisio, 21200, Finland|Novo Nordisk Investigational Site, Tampere, 33900, Finland|Novo Nordisk Investigational Site, Turku, FI-20100, Finland|Novo Nordisk Investigational Site, Bad Mergentheim, 97980, Germany|Novo Nordisk Investigational Site, Berlin, 13597, Germany|Novo Nordisk Investigational Site, Damme, 49401, Germany|Novo Nordisk Investigational Site, Dresden, 01219, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Elsterwerda, 04910, Germany|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Fulda, 36037, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Lingen, 49808, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Münster, 48143, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Oldenburg, 23758, Germany|Novo Nordisk Investigational Site, Rehburg-Loccum, 31547, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Rostock, 18057, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Schweinfurt, 97421, Germany|Novo Nordisk Investigational Site, Völklingen, 66333, Germany|Novo Nordisk Investigational Site, Wangen, 88239, Germany|Novo Nordisk Investigational Site, Zwenkau, 04442, Germany|Novo Nordisk Investigational Site, Budapest, 1076, Hungary|Novo Nordisk Investigational Site, Budapest, 1089, Hungary|Novo Nordisk Investigational Site, Debrecen, 4043, Hungary|Novo Nordisk Investigational Site, Kaposvár, 7400, Hungary|Novo Nordisk Investigational Site, Szeged, H-6720, Hungary|Novo Nordisk Investigational Site, Szombathely, H-9700, Hungary|Novo Nordisk Investigational Site, Bialystok, 15-435, Poland|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Krakow, 31-261, Poland|Novo Nordisk Investigational Site, Lublin, 20-538, Poland|Novo Nordisk Investigational Site, Szczecin, 70-376, Poland|Novo Nordisk Investigational Site, Warszawa, 02-507, Poland|Novo Nordisk Investigational Site, Bath, BA1 3NG, United Kingdom|Novo Nordisk Investigational Site, Gillingham, ME7 5NY, United Kingdom|Novo Nordisk Investigational Site, Glasgow, G21 3UW, United Kingdom|Novo Nordisk Investigational Site, Guildford, GU2 7XX, United Kingdom|Novo Nordisk Investigational Site, Inverness, IV2 3JH, United Kingdom|Novo Nordisk Investigational Site, Inverness, IV2 3UJ, United Kingdom|Novo Nordisk Investigational Site, Ipswich, IP4 5PD, United Kingdom|Novo Nordisk Investigational Site, Nottingham, NG7 2UH, United Kingdom|Novo Nordisk Investigational Site, Portsmouth, PO6 3LY, United Kingdom|Novo Nordisk Investigational Site, Sheffield, S5 7AU, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01831765

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress