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Clinical Trial Details

Trial ID: L1918
Source ID: NCT02008682
Associated Drug: Liraglutide
Title: The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02008682/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: sitagliptin
Outcome Measures: Primary: Change From Baseline in Glycosylated Haemoglobin (HbA1c), Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26., Week 0, week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose, Mean change from baseline in fasting plasma glucose (FPG) at Week 26., Week 0, week 26|Change From Baseline in 7-point Self-measured Plasma Glucose Profile, Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time., Week 0, week 26|Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target), Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26, After 26 weeks of treatment|Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target), Calculated as the percentage of subjects achieving treatment target of HbA1c \<= 6.5% at Week 26, After 26 weeks of treatment|Number of Confirmed Hypoglycaemic Episodes, confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose \< 3.1 mmol/L, Weeks 0-26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 368
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-12
Completion Date: 2014-11
Results First Posted: 2015-12-22
Last Update Posted: 2017-03-09
Locations: Novo Nordisk Investigational Site, Beijing, Beijing, 100071, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100700, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100853, China|Novo Nordisk Investigational Site, ChongQing, Chongqing, 404000, China|Novo Nordisk Investigational Site, Cangzhou, Hebei, 061000, China|Novo Nordisk Investigational Site, Hengshui, Hebei, 053000, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050000, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050051, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210011, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210012, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210029, China|Novo Nordisk Investigational Site, Suzhou, Jiangsu, 215004, China|Novo Nordisk Investigational Site, Wuxi, Jiangsu, 214023, China|Novo Nordisk Investigational Site, Zhenjiang, Jiangsu, 212001, China|Novo Nordisk Investigational Site, Nanchang, Jiangxi, 330006, China|Novo Nordisk Investigational Site, Changchun, Jilin, 130041, China|Novo Nordisk Investigational Site, Dalian, Liaoning, 116033, China|Novo Nordisk Investigational Site, Shenyang, Liaoning, 110021, China|Novo Nordisk Investigational Site, Qingdao, Shandong, 266003, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200080, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200092, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200120, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200240, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 201199, China|Novo Nordisk Investigational Site, Beijing, 101200, China
URL: https://clinicaltrials.gov/show/NCT02008682

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress