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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/NCT01009580
Registration number
NCT01009580
Ethics application status
Date submitted
5/11/2009
Date registered
6/11/2009
Date last updated
19/12/2018
Titles & IDs
Public title
Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
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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)
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Secondary ID [1]
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2008-005768-15
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Secondary ID [2]
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NN5401-3592
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Universal Trial Number (UTN)
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Trial acronym
BOOSTâ„¢
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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 2
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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 - 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.
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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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Change in Glycosylated Haemoglobin (HbA1c)
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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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Secondary outcome [1]
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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 26
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Secondary outcome [2]
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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 26 + 7 days follow up
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Secondary outcome [3]
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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 26 + 7 days follow up
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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
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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
- 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
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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
5/11/2009
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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
23/08/2010
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Sample size
Target
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Accrual to date
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Final
447
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - St Leonards
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Wollongong
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - East Ringwood
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Novo Nordisk Investigational Site - Melbourne
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Recruitment hospital [5]
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Novo Nordisk Investigational Site - Garran
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3135 - East Ringwood
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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2605 - Garran
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Recruitment outside Australia
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Denmark
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Gentofte
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Denmark
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Hjørring
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Horsens
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Hvidovre
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Denmark
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Svendborg
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Denmark
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Århus C
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Finland
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Kuopio
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Finland
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Lahti
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Finland
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Oulu
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Finland
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Pori
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Finland
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Ylitornio
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India
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Haryana
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India
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Karnataka
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India
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Kerala
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India
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Tamil Nadu
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India
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Kolkata
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India
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Mumbai
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India
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New Delhi
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Malaysia
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Cheras
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Malaysia
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Kota Bharu, Kelantan
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Malaysia
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Pulau Pinang
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Malaysia
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Putrajaya
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Bialystok
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Bydgoszcz
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Gniewkowo
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Plock
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Poland
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Rawa Mazowiecka
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Warszawa
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Falun
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Sweden
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Karlstad
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Sweden
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Lund
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Malmö
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Stockholm
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Taiwan
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Changhua
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Taiwan
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Chiayi City
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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Istanbul
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Turkey
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Kocaeli
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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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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01009580
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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. doi: 10.1007/s13300-016-0195-6. Epub 2016 Aug 23.
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Public notes
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Contacts
Principal investigator
Name
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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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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01009580
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