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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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 (BOOSTâ„¢: T1)
Secondary ID [1] 0 0
2008-005769-71
Secondary ID [2] 0 0
NN5401-3594
Universal Trial Number (UTN)
Trial acronym
BOOSTâ„¢
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 - Change from baseline in 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 - 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.
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 - 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.
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) - 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.
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 - 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.
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 - 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.
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 - Change from baseline in 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 - 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.
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 - Change from baseline in 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [2] 0 0
Colorado
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
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United States of America
State/province [6] 0 0
Illinois
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United States of America
State/province [7] 0 0
Kansas
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United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
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United States of America
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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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United States of America
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Washington
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Denmark
State/province [19] 0 0
Aalborg
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Denmark
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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
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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
Country [26] 0 0
Israel
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Petah Tikva
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Israel
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Rishon Le Zion
Country [28] 0 0
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
State/province [33] 0 0
Bayamon
Country [34] 0 0
Romania
State/province [34] 0 0
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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Romania
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Buzau
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Romania
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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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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Penza
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Russian Federation
State/province [45] 0 0
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
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00978627
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(®) T1). Diabet Med. 2017 Feb;34(2):167-173. doi: 10.1111/dme.13068. Epub 2016 Feb 19.
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

Summary results
Other publications