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Clinical Trial Details

Trial ID: L5004
Source ID: NCT01165684
Associated Drug: Insulin Aspart
Title: Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen
Acronym: Full STEP™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01165684/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin aspart|DRUG: insulin aspart|DRUG: insulin detemir
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32, Estimated mean change from baseline in HbA1c after 32 Weeks of treatment, Week 0, Week 32 | Secondary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10, Estimated mean change from baseline in HbA1c after 10 Weeks of treatment, Week 0, Week 10|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21, Estimated mean change from baseline in HbA1c after 21 Weeks of treatment, Week 0, Week 21|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10, Proportion of subjects reaching HbA1c below 7.0% at Week 10, Week 10|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21, Proportion of subjects reaching HbA1c below 7.0% at Week 21, Week 21|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32, Proportion of subjects reaching HbA1c below 7.0% at Week 32, Week 32|Fasting Plasma Glucose (FPG) at Week 10, Mean FPG at Week 10, Week 10|Fasting Plasma Glucose (FPG) at Week 21, Mean FPG at Week 21, Week 21|Fasting Plasma Glucose (FPG) at Week 32, Estimated Mean FPG at Week 32, Week 32|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10, Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10, Week 10|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21, Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21, Week 21|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32, Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32, Week 32|Body Weight at Week 32, Estimated mean body weight after 32 Weeks of treatment, Week 32|Body Mass Index (BMI) at Week 32, Estimated mean BMI after 32 Weeks of treatment, Week 32|Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia 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 randomised treatment and no later than 1 day after the last day of randomised treatment., Week 0 to Week 32
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 401
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-10
Completion Date: 2012-04
Results First Posted: 2013-06-11
Last Update Posted: 2017-02-17
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35216, United States|Novo Nordisk Investigational Site, Mesa, Arizona, 85206, United States|Novo Nordisk Investigational Site, Scottsdale, Arizona, 85251, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Miami, Florida, 33165, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33313, United States|Novo Nordisk Investigational Site, Port Charlotte, Florida, 33952, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30308-2253, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60616, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Springfield, Massachusetts, 01199, United States|Novo Nordisk Investigational Site, Brooklyn Center, Minnesota, 55430, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89148, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, Beavercreek, Ohio, 45432, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Kettering, Ohio, 45429, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75235-6233, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84102, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84107, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Buenos Aires, B1636DSU, Argentina|Novo Nordisk Investigational Site, Buenos Aires, B1704ETD, Argentina|Novo Nordisk Investigational Site, Buenos Aires, C1250AAN, Argentina|Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Caba, C1440AAD, Argentina|Novo Nordisk Investigational Site, Córdoba, X5006IKK, Argentina|Novo Nordisk Investigational Site, Mendoza, 5500, Argentina|Novo Nordisk Investigational Site, Goiania, Goias, 74043-011, Brazil|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01244-030, Brazil|Novo Nordisk Investigational Site, Campinas, 13084-971, Brazil|Novo Nordisk Investigational Site, Porto Alegre, 90035-170, Brazil|Novo Nordisk Investigational Site, Rio de Janeiro, 20211-340, Brazil|Novo Nordisk Investigational Site, Calgary, Alberta, T2N 4L7, Canada|Novo Nordisk Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|Novo Nordisk Investigational Site, Langley, British Columbia, V3A 4H9, Canada|Novo Nordisk Investigational Site, Vancouver, British Columbia, V5Z 1M9, Canada|Novo Nordisk Investigational Site, Victoria, British Columbia, V8V 3N7, Canada|Novo Nordisk Investigational Site, Chatham, Ontario, N7L 1C1, Canada|Novo Nordisk Investigational Site, Kingston, Ontario, K7L 2V7, Canada|Novo Nordisk Investigational Site, Gatineau, Quebec, J8V 2P5, Canada|Novo Nordisk Investigational Site, Lachine, Quebec, H8S 2E4, Canada|Novo Nordisk Investigational Site, Mirabel, Quebec, J7J 2K8, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H2W 1R7, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H3T 1E2, Canada|Novo Nordisk Investigational Site, Marseille, 13009, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Sète, 34200, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Novo Nordisk Investigational Site, Brezice, 8250, Slovenia|Novo Nordisk Investigational Site, Kranj, 4000, Slovenia|Novo Nordisk Investigational Site, Novo mesto, 8000, Slovenia|Novo Nordisk Investigational Site, Trbovlje, 1420, Slovenia
URL: https://clinicaltrials.gov/show/NCT01165684

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress