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Clinical Trial Details

Trial ID: L3513
Source ID: NCT01618214
Associated Drug: Biphasic Insulin Aspart 30
Title: Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01618214/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart 30
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS)., Week 0, week 20 | Secondary: Percentage of Subjects Achieving HbA1c Below 7.0%, After 20 weeks of treatment|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%, After 20 weeks of treatment|Change From Baseline in FPG (Fasting Plasma Glucose), Week 0, week 20|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only), Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value \< 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms., Week 0 to week 20 (inclusive).
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 344
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-06
Completion Date: 2013-01
Results First Posted: 2014-05-08
Last Update Posted: 2017-02-24
Locations: Novo Nordisk Investigational Site, Hefei, Anhui, 230001, China|Novo Nordisk Investigational Site, Hefei, Anhui, 230022, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100029, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100088, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100700, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100730, China|Novo Nordisk Investigational Site, Chongqing, Chongqing, 400010, China|Novo Nordisk Investigational Site, ChongQing, Chongqing, 404000, China|Novo Nordisk Investigational Site, Guangzhou, Guangdong, 510080, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050051, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050082, China|Novo Nordisk Investigational Site, Wuhan, Hubei, 430034, China|Novo Nordisk Investigational Site, Tongliao, Inner Mongolia, 028007, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210011, China|Novo Nordisk Investigational Site, Yangzhou, Jiangsu, 225001, China|Novo Nordisk Investigational Site, Nanchang, Jiangxi, 330006, China|Novo Nordisk Investigational Site, Changchun, Jilin, 130041, China|Novo Nordisk Investigational Site, Siping, Jilin, 136000, China|Novo Nordisk Investigational Site, Xi'an, Shaanxi, 710032, China|Novo Nordisk Investigational Site, Jinan, Shandong, 250013, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200072, China|Novo Nordisk Investigational Site, Hangzhou, Zhejiang, 310003, China
URL: https://clinicaltrials.gov/show/NCT01618214