Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Secondary ID [1] 0 0
2008-005769-71
Secondary ID [2] 0 0
NN5401-3594
Universal Trial Number (UTN)
Trial acronym
BOOST™
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Timepoint [1] 0 0
Week 0, Week 26
Primary outcome [2] 0 0
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Timepoint [2] 0 0
Week 0 to Week 53 + 7 days follow up
Primary outcome [3] 0 0
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Timepoint [3] 0 0
Week 0 to Week 53 + 7 days follow up
Primary outcome [4] 0 0
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Timepoint [4] 0 0
Week 0 to Week 53 + 7 days of follow up
Secondary outcome [1] 0 0
Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Timepoint [1] 0 0
Week 0 to Week 26 + 7 days follow up
Secondary outcome [2] 0 0
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Timepoint [3] 0 0
Week 0, Week 53
Secondary outcome [4] 0 0
Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Timepoint [4] 0 0
Week 0 to Week 26 + 7 days follow up
Secondary outcome [5] 0 0
Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Timepoint [5] 0 0
Week 0, Week 53

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
548
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Coffs Harbour
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
5035 - Keswick
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Montana
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Denmark
State/province [19] 0 0
Aalborg
Country [20] 0 0
Denmark
State/province [20] 0 0
Gentofte
Country [21] 0 0
Denmark
State/province [21] 0 0
Århus C
Country [22] 0 0
France
State/province [22] 0 0
Auxerre
Country [23] 0 0
France
State/province [23] 0 0
Narbonne
Country [24] 0 0
France
State/province [24] 0 0
Nimes
Country [25] 0 0
France
State/province [25] 0 0
Pointe à Pitre
Country [26] 0 0
Israel
State/province [26] 0 0
Petah Tikva
Country [27] 0 0
Israel
State/province [27] 0 0
Rishon Le Zion
Country [28] 0 0
Israel
State/province [28] 0 0
Tel Hashomer
Country [29] 0 0
Poland
State/province [29] 0 0
Lodz
Country [30] 0 0
Poland
State/province [30] 0 0
Sopot
Country [31] 0 0
Poland
State/province [31] 0 0
Szczecin
Country [32] 0 0
Poland
State/province [32] 0 0
Warszawa
Country [33] 0 0
Puerto Rico
State/province [33] 0 0
Bayamon
Country [34] 0 0
Romania
State/province [34] 0 0
Cluj
Country [35] 0 0
Romania
State/province [35] 0 0
Brasov
Country [36] 0 0
Romania
State/province [36] 0 0
Bucharest
Country [37] 0 0
Romania
State/province [37] 0 0
Buzau
Country [38] 0 0
Romania
State/province [38] 0 0
Iasi
Country [39] 0 0
Romania
State/province [39] 0 0
Oradea
Country [40] 0 0
Romania
State/province [40] 0 0
Sibiu
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Kemerovo
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Kursk
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Penza
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Saint-Petersburg
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Samara
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Saratov
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Smolensk
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Volgograd
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Bristol
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Dundee
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Edinburgh
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Leicester
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Liverpool
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Oxford
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Salford
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Wirral, Merseyside

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Hirsch IB, Bode B, Courreges JP, Dykiel P, Franek ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00978627