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Clinical Trial Details

Trial ID: L2677
Source ID: NCT01123980
Associated Drug: Biphasic Insulin Aspart 30
Title: Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment
Acronym: EasyMix
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01123980/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart 30|DRUG: metformin|DRUG: glimepiride|DRUG: insulin glargine
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Week 0, week 24 | Secondary: 9-point Plasma Glucose Profiles, Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day., Week 24|Percentage of Subjects Achieving HbA1c Below 7.0%, The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment, Week 24|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%, The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment, Week 24|Number of Hypoglycaemic Episodes - All, Weeks 0-24|Number of Hypoglycaemic Episodes - Severe and Minor, Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L., Weeks 0-24|Number of Hypoglycaemic Episodes, All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included))., Weeks 0-24
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 521
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-05
Completion Date: 2011-06
Results First Posted: 2012-07-09
Last Update Posted: 2017-02-24
Locations: Novo Nordisk Investigational Site, Beijing, Beijing, 100029, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100101, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100191, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100700, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100853, China|Novo Nordisk Investigational Site, Chongqing, Chongqing, 400010, China|Novo Nordisk Investigational Site, Fuzhou, Fujian, 350025, China|Novo Nordisk Investigational Site, Harbin, Heilongjiang, 150001, China|Novo Nordisk Investigational Site, Zhengzhou, Henan, 450052, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210012, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210029, China|Novo Nordisk Investigational Site, Wuxi, Jiangsu, 214023, China|Novo Nordisk Investigational Site, Nanchang, Jiangxi, 330006, China|Novo Nordisk Investigational Site, Dalian, Liaoning, 116011, China|Novo Nordisk Investigational Site, Shenyang, Liaoning, 110004, China|Novo Nordisk Investigational Site, Shenyang, Liaoning, 110021, China|Novo Nordisk Investigational Site, Xi'an, Shaanxi, 710061, China|Novo Nordisk Investigational Site, Tianjin, Tianjin, 300052, China|Novo Nordisk Investigational Site, Tianjin, Tianjin, 300070, China|Novo Nordisk Investigational Site, Shenyang, 110001, China|Novo Nordisk Investigational Site, Tianjin, 300211, China|Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, 078 8510, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0002, Japan|Novo Nordisk Investigational Site, Gifu city, Gifu, 5008717, Japan|Novo Nordisk Investigational Site, Higashi-ku, 812 8582, Japan|Novo Nordisk Investigational Site, Kumamoto-shi,Kumamoto, 862 0976, Japan|Novo Nordisk Investigational Site, Minato-ku, 108 0073, Japan|Novo Nordisk Investigational Site, Osaka-shi, Osaka, 545 8586, Japan|Novo Nordisk Investigational Site, Osaka-shi, 5300025, Japan|Novo Nordisk Investigational Site, Shimotsuka-gun, 321 0293, Japan|Novo Nordisk Investigational Site, Shimotsuke-shi, Tochigi, 329 0433, Japan|Novo Nordisk Investigational Site, Shizuoka-shi, 424 0853, Japan|Novo Nordisk Investigational Site, Tagajo-shi, 985 0852, Japan|Novo Nordisk Investigational Site, Yokohama-shi, 235 0045, Japan
URL: https://clinicaltrials.gov/show/NCT01123980