Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
NCT ID: NCT01009580
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
447 participants
INTERVENTIONAL
2009-11-05
2010-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDegAsp BID
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.
BIAsp 30 BID
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
St Leonards, New South Wales, Australia
Novo Nordisk Investigational Site
Wollongong, New South Wales, Australia
Novo Nordisk Investigational Site
East Ringwood, Victoria, Australia
Novo Nordisk Investigational Site
Melbourne, Victoria, Australia
Novo Nordisk Investigational Site
Garran, , Australia
Novo Nordisk Investigational Site
Århus C, , Denmark
Novo Nordisk Investigational Site
Copenhagen, , Denmark
Novo Nordisk Investigational Site
Gentofte Municipality, , Denmark
Novo Nordisk Investigational Site
Hjørring, , Denmark
Novo Nordisk Investigational Site
Horsens, , Denmark
Novo Nordisk Investigational Site
Hvidovre, , Denmark
Novo Nordisk Investigational Site
Svendborg, , Denmark
Novo Nordisk Investigational Site
Kuopio, , Finland
Novo Nordisk Investigational Site
Lahti, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
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Pori, , Finland
Novo Nordisk Investigational Site
Ylitornio, , Finland
Novo Nordisk Investigational Site
Karnāl, Haryana, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India
Novo Nordisk Investigational Site
Trivandrum, Kerala, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, , India
Novo Nordisk Investigational Site
Mumbai, , India
Novo Nordisk Investigational Site
New Delhi, , India
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Pulau Pinang, , Malaysia
Novo Nordisk Investigational Site
Putrajaya, , Malaysia
Novo Nordisk Investigational Site
Bialystok, , Poland
Novo Nordisk Investigational Site
Bydgoszcz, , Poland
Novo Nordisk Investigational Site
Gniewkowo, , Poland
Novo Nordisk Investigational Site
Płock, , Poland
Novo Nordisk Investigational Site
Rawa Mazowiecka, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Falun, , Sweden
Novo Nordisk Investigational Site
Karlstad, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Malmo, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
Changhua, , Taiwan
Novo Nordisk Investigational Site
Chiayi City, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Chiang Mai, , Thailand
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Kocaeli, , Turkey (Türkiye)
Countries
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References
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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.
Fulcher GR, Christiansen JS, Bantwal G, Polaszewska-Muszynska M, Mersebach H, Andersen TH, Niskanen LK; BOOST: Intensify Premix I Investigators. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care. 2014 Aug;37(8):2084-90. doi: 10.2337/dc13-2908. Epub 2014 May 8.
Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016 Sep;8(5):720-8. doi: 10.1111/1753-0407.12355. Epub 2016 Mar 6.
Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.
Fulcher G, Mehta R, Fita EG, Ekelund M, Bain SC. Efficacy and Safety of IDegAsp Versus BIAsp 30, Both Twice Daily, in Elderly Patients with Type 2 Diabetes: Post Hoc Analysis of Two Phase 3 Randomized Controlled BOOST Trials. Diabetes Ther. 2019 Feb;10(1):107-118. doi: 10.1007/s13300-018-0531-0. Epub 2018 Nov 24.
Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-005768-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1111-8545
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-3592
Identifier Type: -
Identifier Source: org_study_id