A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
NCT ID: NCT02906917
Last Updated: 2019-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
532 participants
INTERVENTIONAL
2016-09-20
2017-12-24
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
Insulin degludec/insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.
IGlar + IAsp
Insulin glargine
Administered subcutaneously (s.c. under the skin) once daily.
Insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.
Interventions
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Insulin degludec/insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.
Insulin glargine
Administered subcutaneously (s.c. under the skin) once daily.
Insulin aspart
Administered subcutaneously (s.c. under the skin) 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 Algeria: Male or female, age at least 19 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus
* Treated with any basal insulin for at least 90 days prior to the day of screening
* Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metformin at least 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (at least half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record): i. Insulin secretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii. α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v. Oral combination products (of the allowed individual OADs above)
* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
* Body mass index (BMI) equal to or below 45.0 kg/m\^2
* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)
Exclusion Criteria
* Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal or below 90 days prior to the day of the screening and between screening and randomisation
* Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 60 ml/min/1.73 m\^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening
* Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit (UNL) at screening.
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
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
Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Anaheim, California, United States
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Concord, California, United States
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Fresno, California, United States
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La Jolla, California, United States
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Northridge, California, United States
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Danbury, Connecticut, United States
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Fort Lauderdale, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Roswell, Georgia, United States
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Louisville, Kentucky, United States
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Chesterfield, Missouri, United States
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New York, New York, United States
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Westfield, New York, United States
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Wilmington, North Carolina, United States
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Franklin, Ohio, United States
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Bartlett, Tennessee, United States
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Chattanooga, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Chesapeake, Virginia, United States
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Midlothian, Virginia, United States
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Winchester, Virginia, United States
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Constantine, , Algeria
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Oran, , Algeria
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Sidi Bel Abbes, , Algeria
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Broumov, , Czechia
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Náchod, , Czechia
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Náchod, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Trutnov, , Czechia
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Hyderabad, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Surat, Gujarat, India
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Kozhikode, Kerala, India
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Aurangabad, Maharashtra, India
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Mumbai, Maharashtra, India
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New Dehli, New Delhi, India
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Coimbatore, Tamil Nadu, India
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Kolkata, West Bengal, India
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New Delhi, , India
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Arkhangelsk, , Russia
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Cheboksary, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Saratov, , Russia
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Syktyvkar, , Russia
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Tyumen, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Niš, , Serbia
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Izmir, , Turkey (Türkiye)
Countries
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References
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Philis-Tsimikas A, Astamirova K, Gupta Y, Haggag A, Roula D, Bak BA, Fita EG, Nielsen AM, Demir T. Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2019 Jan;147:157-165. doi: 10.1016/j.diabres.2018.10.024. Epub 2018 Nov 16.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-004768-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1175-7895
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-4266
Identifier Type: -
Identifier Source: org_study_id
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