Clinical Trial Details
| Trial ID: | L5167 |
| Source ID: | NCT01513590 |
| Associated Drug: | Insulin Degludec/Insulin Aspart |
| Title: | A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes |
| Acronym: | BOOST™ |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01513590/results |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: insulin degludec/insulin aspart |
| Outcome Measures: | Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Change from baseline in HbA1c after 26 weeks of treatment., Week 0, week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG), Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment., Week 0, week 26|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes, The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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 am., Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes, The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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., Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|Change From Baseline in Body Weight, Change from baseline in body weight after 26 weeks of treatment., Week 0, week 26|Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks, Responder for HbA1c (\<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L., Week 26|Number of Treatment Emergent AEs (Adverse Events), A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator., Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 394 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-01-16 |
| Completion Date: | 2012-11-19 |
| Results First Posted: | 2015-11-20 |
| Last Update Posted: | 2019-03-26 |
| Locations: | Novo Nordisk Investigational Site, Algiers, 16000, Algeria|Novo Nordisk Investigational Site, Oran, 31000, Algeria|Novo Nordisk Investigational Site, Setif, 19000, Algeria|Novo Nordisk Investigational Site, Haskovo, 6300, Bulgaria|Novo Nordisk Investigational Site, Lukovit, 5770, Bulgaria|Novo Nordisk Investigational Site, Plovdiv, 4002, Bulgaria|Novo Nordisk Investigational Site, Ruse, 7000, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1233, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1606, Bulgaria|Novo Nordisk Investigational Site, Karlovac, 47000, Croatia|Novo Nordisk Investigational Site, Osijek, 31 000, Croatia|Novo Nordisk Investigational Site, Rijeka, 51 000, Croatia|Novo Nordisk Investigational Site, Zadar, 23000, Croatia|Novo Nordisk Investigational Site, Zagreb, 10000, Croatia|Novo Nordisk Investigational Site, Brno, 65691, Czechia|Novo Nordisk Investigational Site, Hradec Kralove, 50005, Czechia|Novo Nordisk Investigational Site, Praha 10, 100 00, Czechia|Novo Nordisk Investigational Site, Praha, 128 08, Czechia|Novo Nordisk Investigational Site, Bochum, 44869, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Völklingen, 66333, Germany|Novo Nordisk Investigational Site, Wangen, 88239, Germany|Novo Nordisk Investigational Site, Bialystok, 15-445, Poland|Novo Nordisk Investigational Site, Lublin, 20-044, Poland|Novo Nordisk Investigational Site, Lublin, 20-538, Poland|Novo Nordisk Investigational Site, Mazowieckie, 09-400, Poland|Novo Nordisk Investigational Site, Warszawa, 02-507, Poland|Novo Nordisk Investigational Site, Oradea, Bihor, 410469, Romania|Novo Nordisk Investigational Site, Bucharest, 020614, Romania|Novo Nordisk Investigational Site, Buzau, 120203, Romania|Novo Nordisk Investigational Site, Galati, 800578, Romania|Novo Nordisk Investigational Site, Sibiu, 550176, Romania|Novo Nordisk Investigational Site, Bratislava, 821 02, Slovakia|Novo Nordisk Investigational Site, Kosice, 040 01, Slovakia|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Istanbul, 34096, Turkey|Novo Nordisk Investigational Site, Istanbul, 34890, Turkey|Novo Nordisk Investigational Site, Istanbul, Turkey|Novo Nordisk Investigational Site, Kocaeli, 41380, Turkey|Novo Nordisk Investigational Site, Dnipro, 49023, Ukraine|Novo Nordisk Investigational Site, Kyiv, 04114, Ukraine|Novo Nordisk Investigational Site, Lviv, 79010, Ukraine|Novo Nordisk Investigational Site, Poltava, 36003, Ukraine|Novo Nordisk Investigational Site, Poltava, 36011, Ukraine|Novo Nordisk Investigational Site, Vinnytsia, 21010, Ukraine|Novo Nordisk Investigational Site, Zhytomyr, 10002, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT01513590 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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