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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
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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Illinois
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Kansas
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Kentucky
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New York
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North Carolina
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South Carolina
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Texas
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Washington
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Denmark
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Aalborg
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Denmark
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Gentofte
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Denmark
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Århus C
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France
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Auxerre
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France
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Narbonne
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France
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Nimes
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France
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Pointe à Pitre
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Israel
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Petah Tikva
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Israel
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Rishon Le Zion
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Israel
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Tel Hashomer
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Poland
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Lodz
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Poland
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Sopot
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Poland
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Szczecin
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Poland
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Warszawa
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Puerto Rico
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Bayamon
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Romania
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Cluj
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Romania
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Brasov
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Romania
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Bucharest
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Buzau
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Iasi
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Romania
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Oradea
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Romania
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Sibiu
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Russian Federation
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Kemerovo
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Kursk
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Moscow
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Russian Federation
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Penza
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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Volgograd
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United Kingdom
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Bristol
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United Kingdom
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Dundee
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United Kingdom
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Edinburgh
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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Oxford
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United Kingdom
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Salford
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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