Clinical Trial Details
| Trial ID: | L4353 |
| Source ID: | NCT01680341 |
| Associated Drug: | Insulin Degludec/Insulin Aspart |
| Title: | Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine |
| Acronym: | BOOST® |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01680341/results |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: insulin degludec/insulin aspart|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|Subjects With HbA1c Below 7.0%, Number of subjects with HbA1c below 7% after 26 weeks of treatment., Week 26|Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia, Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment., Week 26|Incidence of Treatment Emergent Adverse Events (TEAEs), 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., Weeks 0-28|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes, Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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., Weeks 0-27|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period, Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up \[Week 27\]) consisted of episodes of severe hypoglycaemia and 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., From week 16 to end of trial including follow-up (week 27)|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes, Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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 am., Weeks 0-27 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 272 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-08-31 |
| Completion Date: | 2013-08-22 |
| Results First Posted: | 2015-11-17 |
| Last Update Posted: | 2018-04-02 |
| Locations: | Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Saint Petersburg, Florida, 33709, United States|Novo Nordisk Investigational Site, Suwanee, Georgia, 30024, United States|Novo Nordisk Investigational Site, Avon, Illinois, 46123, United States|Novo Nordisk Investigational Site, Crystal Lake, Illinois, 60012, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Charleston, South Carolina, 29407, United States|Novo Nordisk Investigational Site, Myrtle Beach, South Carolina, 29572, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76132, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Tacoma, Washington, 98405, United States|Novo Nordisk Investigational Site, Kenosha, Wisconsin, 53144, United States|Novo Nordisk Investigational Site, Algiers, 16000, Algeria|Novo Nordisk Investigational Site, Oran, 31000, Algeria|Novo Nordisk Investigational Site, Tizi Ouzou, 16015, Algeria|Novo Nordisk Investigational Site, Erdmannhausen, 71729, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Pohlheim, 35415, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Saint Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Selangor, 46150, Malaysia|Novo Nordisk Investigational Site, Antalya, 07050, Turkey|Novo Nordisk Investigational Site, Denizli, 20070, Turkey|Novo Nordisk Investigational Site, Gaziantep, 27070, Turkey|Novo Nordisk Investigational Site, Hatay, 31040, Turkey|Novo Nordisk Investigational Site, Istanbul, 34752, Turkey |
| URL: | https://clinicaltrials.gov/show/NCT01680341 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|