Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes
NCT ID: NCT01045447
Last Updated: 2017-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
465 participants
INTERVENTIONAL
2010-01-31
2010-10-31
Brief Summary
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The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.
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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 OD
insulin degludec/insulin aspart
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.
IGlar OD
insulin glargine
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Interventions
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insulin degludec/insulin aspart
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.
insulin glargine
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn \[NPH\] insulin) once daily (OD), for at least 3 months
* Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs) for at least 3 months prior to randomisation
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* BMI maximum 40.0 kg/m\^2
Exclusion Criteria
* Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months prior to visit 1
* Current rosiglitazone users
* 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)
* Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer hereof (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
Fresno, California, United States
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States
Novo Nordisk Investigational Site
Boynton Beach, Florida, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Des Moines, Iowa, United States
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Baltimore, Maryland, United States
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Hyattsville, Maryland, United States
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Waltham, Massachusetts, United States
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Southfield, Michigan, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Nashua, New Hampshire, United States
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Albany, New York, United States
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Statesville, North Carolina, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Round Rock, Texas, United States
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Osijek, , Croatia
Novo Nordisk Investigational Site
Rijeka, , Croatia
Novo Nordisk Investigational Site
Antibes, , France
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Besançon, , France
Novo Nordisk Investigational Site
Dax, , France
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Paris, , France
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Perpignan, , France
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Saint-Herblain, , France
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Sète, , France
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India
Novo Nordisk Investigational Site
Belagavi, Karnataka, India
Novo Nordisk Investigational Site
Mangalore, Karnataka, India
Novo Nordisk Investigational Site
Thiruvanathapuram, Kerala, India
Novo Nordisk Investigational Site
Pune, Maharashtra, India
Novo Nordisk Investigational Site
Bhubaneswar, Odisha, India
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Kanpur, , India
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Gdansk, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Johannesburg, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Benoni, , South Africa
Novo Nordisk Investigational Site
Busan, , South Korea
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Daegu, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Sungnam, , South Korea
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Ängelholm, , Sweden
Novo Nordisk Investigational Site
Dalby, , Sweden
Novo Nordisk Investigational Site
Gothenburg, , Sweden
Novo Nordisk Investigational Site
Härnösand, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
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
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Kahramanmaraş, , Turkey (Türkiye)
Countries
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References
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Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.
Kumar S, Jang HC, Demirag NG, Skjoth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017 Feb;34(2):180-188. doi: 10.1111/dme.13125. Epub 2016 Jul 28.
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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U1111-1111-7226
Identifier Type: OTHER
Identifier Source: secondary_id
2008-005767-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN5401-3593
Identifier Type: -
Identifier Source: org_study_id
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