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Clinical Trial Details

Trial ID: L2952
Source ID: NCT01819129
Associated Drug: Faster-Acting Insulin Aspart
Title: Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
Acronym: onset® 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01819129/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Faster-acting insulin aspart|DRUG: Insulin aspart|DRUG: Insulin glargine
Outcome Measures: Primary: Change From Baseline in HbA1c, The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement., Week 0, Week 26 | Secondary: Change From Baseline in 2-hour PPG Increment (Meal Test), For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement., Week 0, week 26|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes, A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia., From Week 0 to Week 26.|Change From Baseline in Body Weight, For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement., Week 0, week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 881
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-09-09
Completion Date: 2015-01-22
Results First Posted: 2017-12-05
Last Update Posted: 2019-01-30
Locations: Novo Nordisk Investigational Site, Glendale, Arizona, 85306-4652, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85308, United States|Novo Nordisk Investigational Site, Mesa, Arizona, 85213, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85020, United States|Novo Nordisk Investigational Site, Tempe, Arizona, 85283, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, Lomita, California, 90717, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Aurora, Colorado, 80045, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80910, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06708, United States|Novo Nordisk Investigational Site, Boynton Beach, Florida, 33472, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Cooper City, Florida, 33024, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33316, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32205, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Miami, Florida, 33144, United States|Novo Nordisk Investigational Site, Miami, Florida, 33173, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33603, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30308-2253, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30328, United States|Novo Nordisk Investigational Site, Decatur, Georgia, 30033, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Avon, Illinois, 46123, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61602, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Muncie, Indiana, 47304, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40206, United States|Novo Nordisk Investigational Site, Madisonville, Kentucky, 42431-1661, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42003, United States|Novo Nordisk Investigational Site, Monroe, Louisiana, 71203, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Detroit, Michigan, 48201, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48085-5524, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Saint Louis, Missouri, 63141, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Elkhorn, Nebraska, 68022, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68105, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68198-3020, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Mineola, New York, 11501, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, North Massapequa, New York, 11758-1802, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Hickory, North Carolina, 28601, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Carlisle, Ohio, 45005, United States|Novo Nordisk Investigational Site, Cleveland, Ohio, 44122, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States|Novo Nordisk Investigational Site, Mason, Ohio, 45040-6815, United States|Novo Nordisk Investigational Site, East Providence, Rhode Island, 02914, United States|Novo Nordisk Investigational Site, Gaffney, South Carolina, 29341, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404-1192, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Spring Hill, Tennessee, 37174, United States|Novo Nordisk Investigational Site, Tullahoma, Tennessee, 37388, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Hurst, Texas, 76054, United States|Novo Nordisk Investigational Site, Plano, Texas, 75075, United States|Novo Nordisk Investigational Site, Murray, Utah, 84123, United States|Novo Nordisk Investigational Site, Midlothian, Virginia, 23114, United States|Novo Nordisk Investigational Site, Port Orchard, Washington, 98366, United States|Novo Nordisk Investigational Site, Kenosha, Wisconsin, 53144, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Edmonton, Alberta, T5J 3N4, Canada|Novo Nordisk Investigational Site, Surrey, British Columbia, V3S 2N6, Canada|Novo Nordisk Investigational Site, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Novo Nordisk Investigational Site, St. John's, Newfoundland and Labrador, A1A 3R5, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8M 1K7, Canada|Novo Nordisk Investigational Site, Thunder Bay, Ontario, P7B 7C7, Canada|Novo Nordisk Investigational Site, Waterloo, Ontario, N2J 1C4, Canada|Novo Nordisk Investigational Site, Mirabel, Quebec, J7J 2K8, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H1Y 3L1, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H2R 1V6, Canada|Novo Nordisk Investigational Site, St. Romuald, Quebec, G6W 5M6, Canada|Novo Nordisk Investigational Site, Quebec, G1G 3Y8, Canada|Novo Nordisk Investigational Site, Quebec, G1N 4V3, Canada|Novo Nordisk Investigational Site, Cakovec, 40000, Croatia|Novo Nordisk Investigational Site, Karlovac, 47000, Croatia|Novo Nordisk Investigational Site, Osijek, 31 000, Croatia|Novo Nordisk Investigational Site, Slavonski Brod, 35 000, Croatia|Novo Nordisk Investigational Site, Split, 21 000, Croatia|Novo Nordisk Investigational Site, Varazdin, 42 000, Croatia|Novo Nordisk Investigational Site, Zagreb, 10 000, Croatia|Novo Nordisk Investigational Site, Zagreb, 10000, Croatia|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500082, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400012, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400058, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411004, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411040, India|Novo Nordisk Investigational Site, Delhi, New Delhi, 110002, India|Novo Nordisk Investigational Site, Bhubaneswar, Orissa, 751019, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302006, India|Novo Nordisk Investigational Site, Beer Sheva, 84101, Israel|Novo Nordisk Investigational Site, Haifa, 35152, Israel|Novo Nordisk Investigational Site, Jerusalem, 91120, Israel|Novo Nordisk Investigational Site, Kfar Saba, 44281, Israel|Novo Nordisk Investigational Site, Rehovot, 76100, Israel|Novo Nordisk Investigational Site, Rishon Le Zion, 75650, Israel|Novo Nordisk Investigational Site, Ponce, 00717, Puerto Rico|Novo Nordisk Investigational Site, Kursk, 305035, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119435, Russian Federation|Novo Nordisk Investigational Site, Moscow, 127644, Russian Federation|Novo Nordisk Investigational Site, Penza, 440026, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 191119, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194291, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194358, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 195257, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 199034, Russian Federation|Novo Nordisk Investigational Site, Saint-Petesburg, 195257, Russian Federation|Novo Nordisk Investigational Site, Stavropol, 355035, Russian Federation|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Nis, 18000, Serbia|Novo Nordisk Investigational Site, Zajecar, 19000, Serbia|Novo Nordisk Investigational Site, Bratislava, 821 02, Slovakia|Novo Nordisk Investigational Site, Bratislava, 851 01, Slovakia|Novo Nordisk Investigational Site, Lucenec, 984 01, Slovakia|Novo Nordisk Investigational Site, Trnava, 91701, Slovakia|Novo Nordisk Investigational Site, Zilina, 01001, Slovakia|Novo Nordisk Investigational Site, Epworth, DN9 1EP, United Kingdom|Novo Nordisk Investigational Site, Hull, HU3 2RW, United Kingdom|Novo Nordisk Investigational Site, Northampton, NN1 5BD, United Kingdom|Novo Nordisk Investigational Site, Northwood, HA6 2RN, United Kingdom|Novo Nordisk Investigational Site, Norwich, NR4 7TJ, United Kingdom|Novo Nordisk Investigational Site, Nuneaton, CV10 7DJ, United Kingdom|Novo Nordisk Investigational Site, Sidcup, DA14 6LT, United Kingdom|Novo Nordisk Investigational Site, Stoke on Trent, ST4 6QG, United Kingdom|Novo Nordisk Investigational Site, Wrexham, LL13 7TD, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01819129

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress