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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00978627
Registration number
NCT00978627
Ethics application status
Date submitted
16/09/2009
Date registered
17/09/2009
Date last updated
20/03/2017
Titles & IDs
Public title
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
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Scientific title
NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)
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Secondary ID [1]
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2008-005769-71
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Secondary ID [2]
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NN5401-3594
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Universal Trial Number (UTN)
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Trial acronym
BOOST™
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - insulin degludec/insulin aspart
Treatment: Drugs - insulin detemir
Treatment: Drugs - insulin aspart
Treatment: Drugs - insulin aspart
Experimental: IDegAsp OD -
Active Comparator: IDet -
Treatment: Drugs: insulin degludec/insulin aspart
Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
Treatment: Drugs: insulin detemir
Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
Treatment: Drugs: insulin aspart
Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
Treatment: Drugs: insulin aspart
Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
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Assessment method [1]
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Change from baseline in HbA1c after 26 weeks of treatment
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Timepoint [1]
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Week 0, Week 26
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Primary outcome [2]
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Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
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Assessment method [2]
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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.
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Timepoint [2]
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Week 0 to Week 53 + 7 days follow up
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Primary outcome [3]
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Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
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Assessment method [3]
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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.
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Timepoint [3]
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Week 0 to Week 53 + 7 days follow up
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Primary outcome [4]
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Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
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Assessment method [4]
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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.
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Timepoint [4]
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Week 0 to Week 53 + 7 days of follow up
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Secondary outcome [1]
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Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
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Assessment method [1]
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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.
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Timepoint [1]
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Week 0 to Week 26 + 7 days follow up
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Secondary outcome [2]
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Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
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Assessment method [2]
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Overall mean of 9-point 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.
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Timepoint [2]
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Week 26
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Secondary outcome [3]
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Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
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Assessment method [3]
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Change from baseline in HbA1c after 52 weeks of treatment
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Timepoint [3]
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Week 0, Week 53
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Secondary outcome [4]
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Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
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Assessment method [4]
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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.
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Timepoint [4]
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Week 0 to Week 26 + 7 days follow up
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Secondary outcome [5]
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Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
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Assessment method [5]
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Change from baseline in FPG after 52 weeks of treatment.
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Timepoint [5]
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Week 0, Week 53
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Eligibility
Key inclusion criteria
- FOR THE MAIN TRIAL, NN5401-3594:
- Type 1 diabetes mellitus for at least 12 months
- Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin
regimen, self mix regimen) for at least 12 months
- HbA1c 7.0-10.0% (both inclusive)
- BMI (Body Mass Index) below or equal to 35.0 kg/m^2
- FOR THE EXTENSION TRIAL, NN5401-3645:
- The subject must have completed the six-month treatment period in trial NN5401-3594
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- FOR THE MAIN TRIAL, NN5401-3594:
- Treatment with other insulin regimens than insulin in a basal bolus regimen/premix
insulin regimen/self mix regimen within 3 months
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures according to local requirements
- Cancer and medical history of cancer
- FOR THE EXTENSION TRIAL, NN5401-3645:
- Anticipated significant lifestyle changes during the trial
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2010
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Sample size
Target
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Accrual to date
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Final
548
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Broadmeadow
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Camperdown
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - Coffs Harbour
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Recruitment hospital [4]
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Novo Nordisk Investigational Site - Keswick
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Recruitment hospital [5]
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Novo Nordisk Investigational Site - Box Hill
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Recruitment hospital [6]
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Novo Nordisk Investigational Site - Fitzroy
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Recruitment hospital [7]
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Novo Nordisk Investigational Site - Geelong
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Recruitment postcode(s) [1]
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2292 - Broadmeadow
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2450 - Coffs Harbour
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Recruitment postcode(s) [4]
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5035 - Keswick
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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3220 - Geelong
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Aalborg
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Salford
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Wirral, Merseyside
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial is conducted in Europe, Oceania, and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart
(IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes
(main period) followed by the extension period comparing the long-term safety of NN5401 plus
insulin aspart with insulin detemir plus insulin aspart.
The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension
period is registered as NN5401-3645.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00978627
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Trial related presentations / publications
Hirsch IB, Franek E, Mersebach H, Bardtrum L, Hermansen K. Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST(R) T1). Diabet Med. 2017 Feb;34(2):167-173. doi: 10.1111/dme.13068. Epub 2016 Feb 19.
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Public notes
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Contacts
Principal investigator
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Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00978627
Download to PDF