Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes

Last updated: March 19, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Macular Edema

Diabetic Gastroparesis

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT02762578
NN5401-3598
U1111-1118-8578
2011-000085-36
CTR20150689
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.

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 at least 18 years of age

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

  • Insulin treated subjects on current treatment: basal insulin, premixed insulin or aself-mixed insulin regimen, all administered once daily (OD) or BID with or withoutmetformin. The treatment regimen should have remained unchanged for at least 8 weeksprior to randomisation

  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

  • Body mass index (BMI) equal or below 40.0 kg/m^2

Exclusion

Exclusion Criteria:

  • Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidaseinhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) orGLP-1 receptor agonists within 12 weeks prior to screening (Visit 1)

  • Anticipated change in concomitant medication known to interfere significantly withglucose metabolism, such as systemic corticosteroids, beta-blockers and monoamineoxidase (MAO) inhibitors

  • Anticipated significant lifestyle changes during the trial according to the discretionof the investigator, e.g. shift work (including permanent night/evening shiftworkers), as well as highly variable eating habits

  • Cardiovascular disease, within the last 6 months prior to screening (Visit 1), definedas: stroke; decompensated heart failure NYHA1 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 withtype 2 diabetes, which in the investigator's opinion could interfere with the resultsof the trial

  • Previous participation in this trial. Participation is defined as screened.

  • Known or suspected hypersensitivity to trial products or related products

Study Design

Total Participants: 543
Study Start date:
May 03, 2016
Estimated Completion Date:
June 19, 2017

Connect with a study center

  • Novo Nordisk Investigational Site

    Hefei, Anhui 230001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Beijing, Beijing 100101
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    ChongQing, Chongqing 404000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanning, Guangxi 530007
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Cangzhou, Hubei 061001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Baotou, Inner Mongolia 014010
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changchun, Jilin 130033
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Siping, Jilin 136000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jinan, Shandong 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai 200080
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Chengdu, Sichuan 610083
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Kunming, Yunnan 650101
    China

    Site Not Available

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