A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients
NCT ID: NCT02453685
Last Updated: 2019-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
335 participants
INTERVENTIONAL
2015-08-31
2016-09-20
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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BIAsp
biphasic insulin aspart 30
Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.
IGlar + IAsp
insulin glargine
Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.
insulin aspart
Injected s.c./subcutaneously once daily.
Interventions
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biphasic insulin aspart 30
Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.
insulin glargine
Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.
insulin aspart
Injected s.c./subcutaneously once daily.
Eligibility Criteria
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Inclusion Criteria
* Male or female, age at least 18 years at the time of signing informed consent
* Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
* Treatment with stable daily dose (for at least 90 days prior to screening) of: - Metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - Sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, DPP4i (dipeptidyl peptidase-4 inhibitor), SGLT2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
* Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
* HbA1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
* Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. The definition for 'main meal' will be according to the investigator's discretion
Exclusion Criteria
* Impaired liver function, defined as ALT (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
* Inadequately treated high blood pressure defined as Class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm Hg or diastolic equal to or above 100 mm Hg) in accordance with the National High Blood Pressure Education Program, 7th Joint National Committee1 and ESH/ESC 2013 Guidelines2
* Within the past 180 days prior to randomisation, any of the following: Myocardial Infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack
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
Broadmeadow, New South Wales, Australia
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, Australia
Novo Nordisk Investigational Site
Ipswich, Queensland, Australia
Novo Nordisk Investigational Site
Fitzroy, Victoria, Australia
Novo Nordisk Investigational Site
Melbourne, Victoria, Australia
Novo Nordisk Investigational Site
Petrich, , Bulgaria
Novo Nordisk Investigational Site
Sliven, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Nyíregyhaza, , Hungary
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, India
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
New Delhi, , India
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Niš, , Serbia
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
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkoknoi, Bangkok, , Thailand
Novo Nordisk Investigational Site
Khon Kaen, , Thailand
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
Malatya, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Rize, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Ajman, , United Arab Emirates
Novo Nordisk Investigational Site
Dubai, , United Arab Emirates
Novo Nordisk Investigational Site
Ras al-Khaimah, , United Arab Emirates
Novo Nordisk Investigational Site
Umm Al Quwain City, , United Arab Emirates
Countries
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References
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Linjawi S, Lee BW, Tabak O, Lovdahl S, Werther S, Abusnana S. A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal-Bolus Therapy in Insulin-Naive Patients with Type 2 Diabetes. Diabetes Ther. 2018 Feb;9(1):1-11. doi: 10.1007/s13300-017-0334-8. Epub 2017 Nov 11.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2014-003708-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1158-7280
Identifier Type: OTHER
Identifier Source: secondary_id
BIASP-4157
Identifier Type: -
Identifier Source: org_study_id
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