A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes
NCT ID: NCT01513590
Last Updated: 2019-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
394 participants
INTERVENTIONAL
2012-01-16
2012-11-19
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
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.
BIAsp 30 BID
insulin degludec/insulin aspart
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.
Interventions
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insulin degludec/insulin aspart
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
* Current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
* Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days
* Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
* HbA1c (glycosylated haemoglobin) between 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
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
* Anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
* Cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial
* Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
* Known or suspected hypersensitivity to trial products or related products
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
Algiers, , Algeria
Novo Nordisk Investigational Site
Oran, , Algeria
Novo Nordisk Investigational Site
Sétif, , Algeria
Novo Nordisk Investigational Site
Haskovo, , Bulgaria
Novo Nordisk Investigational Site
Lukovit, , Bulgaria
Novo Nordisk Investigational Site
Plovdiv, , Bulgaria
Novo Nordisk Investigational Site
Rousse, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Karlovac, , Croatia
Novo Nordisk Investigational Site
Osijek, , Croatia
Novo Nordisk Investigational Site
Rijeka, , Croatia
Novo Nordisk Investigational Site
Zadar, , Croatia
Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Brno, , Czechia
Novo Nordisk Investigational Site
Hradec Králové, , Czechia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Bochum, , Germany
Novo Nordisk Investigational Site
Hohenmölsen, , Germany
Novo Nordisk Investigational Site
Rehlingen-Siersburg, , Germany
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, , Germany
Novo Nordisk Investigational Site
Völklingen, , Germany
Novo Nordisk Investigational Site
Wangen, , Germany
Novo Nordisk Investigational Site
Bialystok, , Poland
Novo Nordisk Investigational Site
Lublin, , Poland
Novo Nordisk Investigational Site
Lublin, , Poland
Novo Nordisk Investigational Site
Mazowieckie, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Oradea, Bihor County, Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Buzău, , Romania
Novo Nordisk Investigational Site
Galati, , Romania
Novo Nordisk Investigational Site
Sibiu, , Romania
Novo Nordisk Investigational Site
Bratislava, , Slovakia
Novo Nordisk Investigational Site
Košice, , Slovakia
Novo Nordisk Investigational Site
Antalya, , Turkey (Türkiye)
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)
Novo Nordisk Investigational Site
Dnipro, , Ukraine
Novo Nordisk Investigational Site
Kyiv, , Ukraine
Novo Nordisk Investigational Site
Lviv, , Ukraine
Novo Nordisk Investigational Site
Poltava, , Ukraine
Novo Nordisk Investigational Site
Poltava, , Ukraine
Novo Nordisk Investigational Site
Vinnytsia, , Ukraine
Novo Nordisk Investigational Site
Zhytomyr, , Ukraine
Countries
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References
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Franek E, Haluzik M, Canecki Varzic S, Sargin M, Macura S, Zacho J, Christiansen JS. Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naive adults with Type 2 diabetes. Diabet Med. 2016 Apr;33(4):497-505. doi: 10.1111/dme.12982. Epub 2015 Nov 17.
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.
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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2011-001712-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1120-5633
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-3940
Identifier Type: -
Identifier Source: org_study_id
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