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Clinical Trial Details

Trial ID: L6080
Source ID: NCT01059812
Associated Drug: Insulin Degludec/Insulin Aspart
Title: A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes
Acronym: BOOST™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01059812/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: biphasic insulin aspart 30
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment, Change from baseline in HbA1c after 26 weeks of treatment., Week 0, Week 26 | Secondary: Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26, Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast., Week 26|Rate of Confirmed Hypoglycaemic Episodes, Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol., Week 0 to Week 26 + 7 days follow up|Rate of Nocturnal Confirmed Hypoglycaemic Episodes, Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m., Week 0 to Week 26 + 7 days follow up|Change in Body Weight, Change from baseline in body weight after 26 weeks of treatment., Week 0, Week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 424
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-02-01
Completion Date: 2010-12-23
Results First Posted: 2015-11-20
Last Update Posted: 2018-12-20
Locations: Novo Nordisk Investigational Site, Shatin, New Territories, Hong Kong|Novo Nordisk Investigational Site, Chuo-ku,, 104 0061, Japan|Novo Nordisk Investigational Site, Imizu-shi, 939 0363, Japan|Novo Nordisk Investigational Site, Kamakura-shi, 247 0056, Japan|Novo Nordisk Investigational Site, Kashiwara-shi, Osaka, 582-0005, Japan|Novo Nordisk Investigational Site, Koriyama-shi, Fukushima, 963-8851, Japan|Novo Nordisk Investigational Site, Kumamoto-shi, Kumamoto, 862-0976, Japan|Novo Nordisk Investigational Site, Matsumoto-shi, 390 8510, Japan|Novo Nordisk Investigational Site, Naha-shi,, 900 0032, Japan|Novo Nordisk Investigational Site, Naka-shi, Ibaraki, 311-0113, Japan|Novo Nordisk Investigational Site, Oita-shi, 870 0039, Japan|Novo Nordisk Investigational Site, Oyama-shi, Tochigi, 323-0022, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060-0062, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 062-0007, Japan|Novo Nordisk Investigational Site, Takatsuki-shi, Osaka, 569-1096, Japan|Novo Nordisk Investigational Site, Urasoe-shi,, 901 2104, Japan|Novo Nordisk Investigational Site, Yokohama-shi, Kanagawa, 235-0045, Japan|Novo Nordisk Investigational Site, Ansan, 152-703, Korea, Republic of|Novo Nordisk Investigational Site, Daegu, 705-717, Korea, Republic of|Novo Nordisk Investigational Site, Daegu, 705-718, Korea, Republic of|Novo Nordisk Investigational Site, Guri, 471-101, Korea, Republic of|Novo Nordisk Investigational Site, Gyeonggi, 480-717, Korea, Republic of|Novo Nordisk Investigational Site, Incheon, 400-103, Korea, Republic of|Novo Nordisk Investigational Site, Incheon, 405-760, Korea, Republic of|Novo Nordisk Investigational Site, Jeollanamdo, 501-717, Korea, Republic of|Novo Nordisk Investigational Site, Pusan, 602-739, Korea, Republic of|Novo Nordisk Investigational Site, Seongnam-si, 463-707, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 02447, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 02841, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 120-752, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 134-701, Korea, Republic of|Novo Nordisk Investigational Site, Suwon, 16499, Korea, Republic of|Novo Nordisk Investigational Site, Wonju, 220-701, Korea, Republic of|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Georgetown, Penang, 10450, Malaysia|Novo Nordisk Investigational Site, Johor Bahru, 80100, Malaysia|Novo Nordisk Investigational Site, Klang, Selangor, 41200, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Kota Kinabalu, 88586, Malaysia|Novo Nordisk Investigational Site, Putrajaya, 62250, Malaysia|Novo Nordisk Investigational Site, Seremban, 70300, Malaysia|Novo Nordisk Investigational Site, Kaohsiung City, 833, Taiwan|Novo Nordisk Investigational Site, Taichung, 404, Taiwan|Novo Nordisk Investigational Site, Tainan city, 710, Taiwan|Novo Nordisk Investigational Site, Taipei, 100, Taiwan|Novo Nordisk Investigational Site, Taipei, 112, Taiwan
URL: https://clinicaltrials.gov/show/NCT01059812

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