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Clinical Trial Details

Trial ID: L1812
Source ID: NCT01713530
Associated Drug: Insulin Degludec/Insulin Aspart
Title: A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01713530/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: insulin degludec|DRUG: insulin aspart
Outcome Measures: Primary: Change From Baseline in HbA1c (%), Change from baseline in HbA1c (%) after 26 weeks of treatment, Week 0, week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG), Change from baseline in FPG after 26 weeks of treatment, Week 0, week 26|Number of Treatment Emergent Hypoglycaemic Episodes, According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) \<3.1 mmol/L(56 mg/dL)), During Weeks 0-26|Number of Treatment Emergent Hypoglycaemic Episodes, According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia, During Weeks 0-26|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes, Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m., Weeks 0-26|Incidence of Treatment Emergent Adverse Events (TEAE), A TEAE was defined as an event that has 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, Weeks 0-26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 274
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-02-21
Completion Date: 2014-01-09
Results First Posted: 2015-11-17
Last Update Posted: 2018-04-02
Locations: Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, Mission Hills, California, 91345, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Hillsborough, New Jersey, 08844-1225, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Whiteville, North Carolina, 28472, United States|Novo Nordisk Investigational Site, Kettering, Ohio, 45429, United States|Novo Nordisk Investigational Site, Wadsworth, Ohio, 44281-9236, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15236, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78224, United States|Novo Nordisk Investigational Site, Tacoma, Washington, 98405, United States|Novo Nordisk Investigational Site, Martinsburg, West Virginia, 25401, United States|Novo Nordisk Investigational Site, Algiers, Algeria|Novo Nordisk Investigational Site, Annaba, Algeria|Novo Nordisk Investigational Site, Constantine, 25000, Algeria|Novo Nordisk Investigational Site, Oran, 31000, Algeria|Novo Nordisk Investigational Site, Graz, 8036, Austria|Novo Nordisk Investigational Site, Innsbruck, 6020, Austria|Novo Nordisk Investigational Site, Linz, 4021, Austria|Novo Nordisk Investigational Site, Mödling, 2340, Austria|Novo Nordisk Investigational Site, Salzburg, 5010, Austria|Novo Nordisk Investigational Site, Wien, 1090, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Caen, 14033, France|Novo Nordisk Investigational Site, LA ROCHE-sur-YON cedex 9, 85295, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Montpellier, 34000, France|Novo Nordisk Investigational Site, Montpellier, 34070, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Hamar, 2317, Norway|Novo Nordisk Investigational Site, Kongsvinger, 2212, Norway|Novo Nordisk Investigational Site, Kristiansand S, 4604, Norway|Novo Nordisk Investigational Site, Oslo, 0586, Norway|Novo Nordisk Investigational Site, Skedsmokorset, NO-2020, Norway|Novo Nordisk Investigational Site, Stavanger, 4011, Norway
URL: https://clinicaltrials.gov/show/NCT01713530

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress