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Clinical Trial Details

Trial ID: L6183
Source ID: NCT01850615
Associated Drug: Faster-Acting Insulin Aspart
Title: Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes
Acronym: onset® 3
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01850615/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Faster-acting insulin aspart|DRUG: basal insulin
Outcome Measures: Primary: Change From Baseline in HbA1c, For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements., Week 0, week 18 | Secondary: Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal), For this endpoint the "end of trial" data containing last available measurements are presented. PPG measurements were recorded by the subjects at 2 hours after each meal (breakfast, lunch and main evening meal) as part of three 7-point profiles (SMPG) prior to the visits. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements., After 18 weeks of randomised treatment|Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal), For this endpoint the "end of trial" data containing last available measurements are presented. Prandial PG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point profiles (SMPG) as the difference between the PPG value 2 hours after each meal and the PG value before each meal. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements., After 18 weeks of randomised treatment|Change From Baseline in Body Weight, For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements., Week 0, week 18|Number of Treatment Emergent Hypoglycaemic Episodes, Plasma glucose (PG) was measured and recorded when a hypoglycaemic episode was suspected. All PG values ≤3.9 mmol/L (70 mg/dL) or \>3.9 mmol/L (70 mg/dL) when they occurred in conjunction with hypoglycaemic symptoms were recorded by the subject. Numbers of treatment emergent hypoglycaemic episodes were recorded during 18 weeks of treatment., Weeks 0-18|Number of Adverse Events, All adverse events (AEs) described here refer to treatment emergent adverse events (TEAE). A TEAE was defined as an event that had 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, week 18., Weeks 0-18
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 323
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-09-23
Completion Date: 2014-11-17
Results First Posted: 2018-01-17
Last Update Posted: 2019-06-12
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35211, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35216, United States|Novo Nordisk Investigational Site, Peoria, Arizona, 85381, United States|Novo Nordisk Investigational Site, Little Rock, Arkansas, 72205, United States|Novo Nordisk Investigational Site, Santa Ana, California, 92705, United States|Novo Nordisk Investigational Site, Tarzana, California, 91356-3551, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80907, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80922, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33028, United States|Novo Nordisk Investigational Site, Conyers, Georgia, 30094-5965, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70121, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Boston, Massachusetts, 02118, United States|Novo Nordisk Investigational Site, Kalamazoo, Michigan, 49009, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68144, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89120, United States|Novo Nordisk Investigational Site, Brooklyn, New York, 11229, United States|Novo Nordisk Investigational Site, Asheboro, North Carolina, 27203, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45242, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73104, United States|Novo Nordisk Investigational Site, Downingtown, Pennsylvania, 19335-2620, United States|Novo Nordisk Investigational Site, Reading, Pennsylvania, 19609, United States|Novo Nordisk Investigational Site, Greenville, South Carolina, 29605-4254, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119-3821, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76132, United States|Novo Nordisk Investigational Site, Houston, Texas, 77025-1669, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Ogden, Utah, 84405, United States|Novo Nordisk Investigational Site, Buenos Aires, C1250AAN, Argentina|Novo Nordisk Investigational Site, Capital Federal, C1056ABJ, Argentina|Novo Nordisk Investigational Site, Córdoba, X5006IKK, Argentina|Novo Nordisk Investigational Site, Godoy Cruz, M5501ARP, Argentina|Novo Nordisk Investigational Site, San Isidro, B1642DCD, Argentina|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500034, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500082, India|Novo Nordisk Investigational Site, Visakhapatnam, Andhra Pradesh, 530002, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560 017, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400007, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400058, India|Novo Nordisk Investigational Site, New Dehli, New Delhi, 110029, India|Novo Nordisk Investigational Site, Chandigarh, Punjab, 160012, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641018, India|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44150, Mexico|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44650, Mexico|Novo Nordisk Investigational Site, Mexico City, México, D.F., 03300, Mexico|Novo Nordisk Investigational Site, Targu Mures, Mures, 540142, Romania|Novo Nordisk Investigational Site, Ploiesti, Prahova, 100097, Romania|Novo Nordisk Investigational Site, Timisoara, Timis, 300125, Romania|Novo Nordisk Investigational Site, Brasov, 500269, Romania|Novo Nordisk Investigational Site, Suceava, 720237, Romania|Novo Nordisk Investigational Site, Brezice, 8250, Slovenia|Novo Nordisk Investigational Site, Koper, SI-6000, Slovenia|Novo Nordisk Investigational Site, Kranj, 4000, Slovenia|Novo Nordisk Investigational Site, Novo mesto, 8000, Slovenia
URL: https://clinicaltrials.gov/show/NCT01850615

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress