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Clinical Trial Details

Trial ID: L6612
Source ID: NCT01272193
Associated Drug: Insulin Degludec/Insulin Aspart
Title: Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
Acronym: BOOST™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01272193/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: insulin glargine
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Observed change from baseline in HbA1c after 26 weeks of treatment, Week 0, Week 26 | Secondary: Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal, Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal, Week 26|Rate of Treatment Emergent Adverse Events (AEs), Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect., Week 0 to Week 26 + 7 days follow up|Rate of Confirmed Hypoglycaemic Episodes, Observed 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L., Week 0 to Week 26 + 7 days follow up|Rate of Nocturnal Confirmed Hypoglycaemic Episodes, Observed 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m., Week 0 to Week 26 + 7 days follow up|Change in Body Weight, Observed 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: 296
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-01
Completion Date: 2011-09
Results First Posted: 2015-11-23
Last Update Posted: 2017-03-17
Locations: Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, 070 0002, Japan|Novo Nordisk Investigational Site, Chigasaki-shi, Kanagawa, 253 0052, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0002, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0027, Japan|Novo Nordisk Investigational Site, Ebina-shi, 243 0432, Japan|Novo Nordisk Investigational Site, Fukuoka-shi, Fukuoka, 815 8555, Japan|Novo Nordisk Investigational Site, Iruma-shi, Saitama, 358 0003, Japan|Novo Nordisk Investigational Site, Izumisano-shi, 598 0048, Japan|Novo Nordisk Investigational Site, Kamakura-shi, 247 0056, Japan|Novo Nordisk Investigational Site, Kanagawa-shi, Yokohama, 221 0802, Japan|Novo Nordisk Investigational Site, Kashiwa-shi, Chiba, 277 0825, Japan|Novo Nordisk Investigational Site, Kashiwara-shi, Osaka, 582 0005, Japan|Novo Nordisk Investigational Site, Katsushika-ku, Tokyo, 125 0054, Japan|Novo Nordisk Investigational Site, Kawagoe-shi, Saitama, 350 0851, Japan|Novo Nordisk Investigational Site, Kitakyushu-shi, Fukuoka, 800 0252, Japan|Novo Nordisk Investigational Site, Koriyama-shi, Fukushima, 963 8851, Japan|Novo Nordisk Investigational Site, Kumamoto-shi, Kumamoto, 861 8045, Japan|Novo Nordisk Investigational Site, Kumamoto-shi,Kumamoto, 862 0976, Japan|Novo Nordisk Investigational Site, Kurume-shi, Fukuoka, 830 8577, Japan|Novo Nordisk Investigational Site, Kurume-shi, Fukuoka, 839 0863, Japan|Novo Nordisk Investigational Site, Kyoto-shi, Kyoto, 615 8125, Japan|Novo Nordisk Investigational Site, Matsumoto-shi, Nagano, 399 0006, Japan|Novo Nordisk Investigational Site, Miyazaki-shi, 880 0034, Japan|Novo Nordisk Investigational Site, Naha-shi,, 900 0032, Japan|Novo Nordisk Investigational Site, Naka-shi, Ibaraki, 311 0113, Japan|Novo Nordisk Investigational Site, Nishinomiya-shi, Hygo, 662 0971, Japan|Novo Nordisk Investigational Site, Obihiro-shi, Hokkaido, 080 0016, Japan|Novo Nordisk Investigational Site, Obihiro-shi, Hokkaido, 080 0848, Japan|Novo Nordisk Investigational Site, Ogawa-machi, 355 0321, Japan|Novo Nordisk Investigational Site, Oita-shi, 870 0039, Japan|Novo Nordisk Investigational Site, Okawa-shi, Fukuoka, 831 0016, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, 144 0035, Japan|Novo Nordisk Investigational Site, Oyama-shi, Tochigi, 323 0022, Japan|Novo Nordisk Investigational Site, Sapporo, Hokkaido, 060 0033, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060 0062, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060-0001, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 062 0007, Japan|Novo Nordisk Investigational Site, Sappro-shi, Hokkaido, 060 8648, Japan|Novo Nordisk Investigational Site, Sasebo-shi, Nagasaki, 857 1165, Japan|Novo Nordisk Investigational Site, Sendai-shi, 980 0021, 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, Tagawa-shi, Fukuoka, 825 8567, Japan|Novo Nordisk Investigational Site, Takatsuki-shi, Osaka, 569 1096, Japan|Novo Nordisk Investigational Site, Tamana-shi, Kumamoto, 865 0064, Japan|Novo Nordisk Investigational Site, Tokyo, 167 0043, Japan|Novo Nordisk Investigational Site, Tsuchiura-shi, Ibaraki, 300 0832, Japan|Novo Nordisk Investigational Site, Urasoe-shi,, 901 2104, Japan|Novo Nordisk Investigational Site, Yokohama-shi, Kanagawa, 227 0054, Japan
URL: https://clinicaltrials.gov/show/NCT01272193

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