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

Last updated: November 8, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Gastroparesis

Diabetic Neuropathy

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT02906917
NN5401-4266
U1111-1175-7895
2015-004768-12
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-relatedactivities are any procedures that are carried out as part of the trial, includingactivities to determine suitability for the trial

  • 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 dailydose(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 (metforminat 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 ormaximum tolerated dose as documented in subject medical record): i. Insulinsecretagogues (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

Exclusion

Exclusion Criteria:

  • Participation in any clinical trial of an approved or non-approved investigationalmedicinal product within four weeks prior to the day of screening (V1)

  • 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 oftreatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equalor below 90 days prior to the day of the screening and between screening andrandomisation

  • Any of the following: myocardial infarction, stroke or hospitalization for unstableangina or transient ischaemic attack within the past 180 days prior to the day ofscreening and between screening and randomisation

  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value ofbelow 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotopedilution 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 ofscreening

  • Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria in a period of 90 days before the day of screening

  • Anticipated initiation or change in concomitant medications (for more than 14consecutive days) known to affect weight or glucose metabolism (e.g. treatment withorlistat, thyroid hormones, or corticosteroids)

Study Design

Total Participants: 532
Study Start date:
September 20, 2016
Estimated Completion Date:
December 24, 2017

Connect with a study center

  • Novo Nordisk Investigational Site

    Constantine, 25000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Oran, 31000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sidi Bel Abbes, 22000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Broumov, 550 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Nachod, 547 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Prague 4, 140 21
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 4, 140 46
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Trutnov, 541 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh 500072
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Surat, Gujarat 395002
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kozhikode, Kerala 673017
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurangabad, Maharashtra 431005
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra 400058
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi 110029
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu 600086
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Coimbatore, Tamil Nadu 641018
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal 700054
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Delhi, 110001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Cheboksary, 428009
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 127486
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 195213
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saratov, 410053
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Syktyvkar, 167981
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tumen, 625023
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgrade, 11080
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Nis, 18000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Adana, 01250
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Ankara, 06100
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Istanbul, 34718
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Izmir, 35340
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Glendale, Arizona 85306-4652
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, California 94520
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fresno, California 93720
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    La Jolla, California 92037
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Northridge, California 91325
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida 33312
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ft. Lauderdale, Florida 33312
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kissimmee, Florida 34744
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Westfield, New York 14787
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bartlett, Tennessee 38133
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee 37938
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37228
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78758
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390-9302
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78230
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chesapeake, Virginia 23321
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

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