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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01009580




Trial ID
NCT01009580
Ethics application status
Date submitted
5/11/2009
Date registered
5/11/2009
Date last updated
9/02/2017

Titles & IDs
Public title
Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Scientific title
A 26-week, Randomised, Open-labelled, Two-arm, Parallel-group, Treat-to-target Trial Comparing Efficacy and Safety of Soluble Insulin Analogue Combination (SIAC) Twice Daily (BID) With Biphasic Insulin Aspart (BIAsp) 30 BID, With or Without Metformin, With or Without DPP-4 Inhibitor, With or Without Pioglitazone in Subjects With Type 2 Diabetes in Inadequate Glycaemic Control on Once or Twice Daily Premixed or Self-mixed Insulin Regimen With or Without OADs (BOOSTâ„¢: Intensify Premix 1)
Secondary ID [1] 0 0
2008-005768-15
Secondary ID [2] 0 0
NN5401-3592
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 2 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 - biphasic insulin aspart 30

Experimental: IDegAsp BID -

Experimental: BIAsp 30 BID -


Treatment: Drugs: insulin degludec/insulin aspart
Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

Treatment: Drugs: biphasic insulin aspart 30
Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Glycosylated Haemoglobin (HbA1c) - Change from baseline in HbA1c after 26 weeks of treatment.
Timepoint [1] 0 0
Week 0, Week 26
Secondary outcome [1] 0 0
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) - Mean of SMPG after 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 [1] 0 0
Week 26
Secondary outcome [2] 0 0
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 26 + 7 days follow up
Secondary outcome [3] 0 0
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 26 + 7 days follow up

Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

- Subjects on premixed human or analogue insulin or self-mixed insulin regimen,
containing 20-40 % fast/rapid-acting component, once daily (OD) or twice daily (BID),
with or without oral antidiabetic drugs) (OADs) (metformin, sulphonylurea (SU),
glinides, alpha-glucosidase inhibitor, DPP-4 (dipeptidyl peptidase-4) inhibitor and
pioglitazone), for at least 3 months before Visit 1

- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

- Body Mass Index (BMI) below or equal to 40.0 kg/m^2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with other insulin regimens than those listed in key inclusion criterion no.
2 within 3 months

- Treatment with rosiglitazone or glucagon-like peptide-1 (GLP-1) receptor agonists
(exenatide, liraglutide) within 3 months prior to visit 1

- Cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke;
decompensated heart failure New York Heart Association (NYHA) class III or IV;
myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or
angioplasty

- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least
180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures according to local requirements

- Cancer and medical history of cancer (except basal cell skin cancer and squamous cell
skin cancer

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,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - East Ringwood
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3135 - East Ringwood
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
2605 - Garran
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Gentofte
Country [2] 0 0
Denmark
State/province [2] 0 0
Hjørring
Country [3] 0 0
Denmark
State/province [3] 0 0
Horsens
Country [4] 0 0
Denmark
State/province [4] 0 0
Hvidovre
Country [5] 0 0
Denmark
State/province [5] 0 0
København
Country [6] 0 0
Denmark
State/province [6] 0 0
Svendborg
Country [7] 0 0
Denmark
State/province [7] 0 0
Århus C
Country [8] 0 0
Finland
State/province [8] 0 0
Kuopio
Country [9] 0 0
Finland
State/province [9] 0 0
Lahti
Country [10] 0 0
Finland
State/province [10] 0 0
Oulu
Country [11] 0 0
Finland
State/province [11] 0 0
Pori
Country [12] 0 0
Finland
State/province [12] 0 0
Ylitornio
Country [13] 0 0
India
State/province [13] 0 0
Haryana
Country [14] 0 0
India
State/province [14] 0 0
Karnataka
Country [15] 0 0
India
State/province [15] 0 0
Kerala
Country [16] 0 0
India
State/province [16] 0 0
Maharashtra
Country [17] 0 0
India
State/province [17] 0 0
Tamil Nadu
Country [18] 0 0
India
State/province [18] 0 0
Kolkata
Country [19] 0 0
India
State/province [19] 0 0
Mumbai
Country [20] 0 0
India
State/province [20] 0 0
New Delhi
Country [21] 0 0
Malaysia
State/province [21] 0 0
Cheras
Country [22] 0 0
Malaysia
State/province [22] 0 0
Kota Bharu, Kelantan
Country [23] 0 0
Malaysia
State/province [23] 0 0
Pulau Pinang
Country [24] 0 0
Malaysia
State/province [24] 0 0
Putrajaya
Country [25] 0 0
Poland
State/province [25] 0 0
Bialystok
Country [26] 0 0
Poland
State/province [26] 0 0
Bydgoszcz
Country [27] 0 0
Poland
State/province [27] 0 0
Gniewkowo
Country [28] 0 0
Poland
State/province [28] 0 0
Plock
Country [29] 0 0
Poland
State/province [29] 0 0
Rawa Mazowiecka
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Sweden
State/province [31] 0 0
Falun
Country [32] 0 0
Sweden
State/province [32] 0 0
Karlstad
Country [33] 0 0
Sweden
State/province [33] 0 0
Lund
Country [34] 0 0
Sweden
State/province [34] 0 0
Malmö
Country [35] 0 0
Sweden
State/province [35] 0 0
Stockholm
Country [36] 0 0
Taiwan
State/province [36] 0 0
Changhua
Country [37] 0 0
Taiwan
State/province [37] 0 0
Chiayi City
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
Thailand
State/province [39] 0 0
Bangkok
Country [40] 0 0
Thailand
State/province [40] 0 0
Chiang Mai
Country [41] 0 0
Turkey
State/province [41] 0 0
Istanbul
Country [42] 0 0
Turkey
State/province [42] 0 0
Kocaeli

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 Asia, Europe and Oceania. The aim of this clinical trial is to
compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects
with type 2 diabetes.
Trial website
https://clinicaltrials.gov/show/NCT01009580
Trial related presentations / publications
Evans M, Gundgaard J, Hansen BB. Cost-Effectiveness of Insulin Degludec/Insulin Aspart Versus Biphasic Insulin Aspart in Patients with Type 2 Diabetes from a Danish Health-Care Perspective. Diabetes Ther. 2016 Dec;7(4):809-823. Epub 2016 Aug 23.
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