A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes
NCT ID: NCT01059812
Last Updated: 2018-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
424 participants
INTERVENTIONAL
2010-02-01
2010-12-23
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 subcutaneously twice daily. Dose was individually adjusted.
BIAsp 30 BID
biphasic insulin aspart 30
Injected subcutaneously twice daily. Dose was individually adjusted.
Interventions
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insulin degludec/insulin aspart
Injected subcutaneously twice daily. Dose was individually adjusted.
biphasic insulin aspart 30
Injected subcutaneously twice daily. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* Body mass index (BMI) maximum 35.0 kg/m\^2
Exclusion Criteria
* Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists 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 or 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
Shatin, New Territories, , Hong Kong
Novo Nordisk Investigational Site
Chūōku, , Japan
Novo Nordisk Investigational Site
Imizu-shi, , Japan
Novo Nordisk Investigational Site
Kamakura-shi, , Japan
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, , Japan
Novo Nordisk Investigational Site
Kumamoto-shi, Kumamoto, , Japan
Novo Nordisk Investigational Site
Matsumoto-shi, , Japan
Novo Nordisk Investigational Site
Naha, , Japan
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, , Japan
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, , Japan
Novo Nordisk Investigational Site
Ōita, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Urasoe-shi,, , Japan
Novo Nordisk Investigational Site
Yokohama-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
Georgetown, Penang, , Malaysia
Novo Nordisk Investigational Site
Johor Bahru, , Malaysia
Novo Nordisk Investigational Site
Klang, Selangor, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Kota Kinabalu, , Malaysia
Novo Nordisk Investigational Site
Putrajaya, , Malaysia
Novo Nordisk Investigational Site
Seremban, , Malaysia
Novo Nordisk Investigational Site
Ansan, , South Korea
Novo Nordisk Investigational Site
Daegu, , South Korea
Novo Nordisk Investigational Site
Daegu, , South Korea
Novo Nordisk Investigational Site
Guri-si, , South Korea
Novo Nordisk Investigational Site
Gyeonggi-do, , South Korea
Novo Nordisk Investigational Site
Incheon, , South Korea
Novo Nordisk Investigational Site
Incheon, , South Korea
Novo Nordisk Investigational Site
Jeollanamdo, , South Korea
Novo Nordisk Investigational Site
Pusan, , South Korea
Novo Nordisk Investigational Site
Seongnam-si, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Suwon, , South Korea
Novo Nordisk Investigational Site
Wŏnju, , South Korea
Novo Nordisk Investigational Site
Kaohsiung City, , Taiwan
Novo Nordisk Investigational Site
Taichung, , Taiwan
Novo Nordisk Investigational Site
Tainan City, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
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.
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.
Taneda S, Hyllested-Winge J, Gall MA, Kaneko S, Hirao K. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. J Diabetes. 2017 Mar;9(3):243-247. doi: 10.1111/1753-0407.12407. Epub 2016 Jul 7.
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.
Kaneko S, Chow F, Choi DS, Taneda S, Hirao K, Park Y, Andersen TH, Gall MA, Christiansen JS; BOOST: Intensify All Trial Investigators. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial. Diabetes Res Clin Pract. 2015 Jan;107(1):139-47. doi: 10.1016/j.diabres.2014.09.026. Epub 2014 Oct 14.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1111-7210
Identifier Type: OTHER
Identifier Source: secondary_id
101040
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN5401-3597
Identifier Type: -
Identifier Source: org_study_id