Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

Last updated: March 6, 2018
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Kidney Disease

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT01680341
NN5401-3941
U1111-1127-4114
2012-000373-23
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)

  • Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidaseinhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeksprior to Visit 2 (randomisation) and doses should have been stable in this period oftime

  • Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratoryanalysis

  • Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion

Exclusion Criteria:

  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)

  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardialinfarction; unstable angina pectoris; or coronary arterial bypass graft orangioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)

  • Uncontrolled or untreated severe hypertension defined as systolic blood pressure aboveor equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg

  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12months) or hypoglycaemic unawareness as judged by the investigator

  • Life-threatening disease (e.g. cancer)

Study Design

Total Participants: 272
Study Start date:
August 31, 2012
Estimated Completion Date:
August 22, 2013

Connect with a study center

  • Novo Nordisk Investigational Site

    Algiers, 16000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Oran, 31000
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Tizi Ouzou, 16015
    Algeria

    Site Not Available

  • Novo Nordisk Investigational Site

    Erdmannhausen, 71729
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Münster, 48145
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Neuwied, 56564
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Pohlheim, 35415
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386
    Germany

    Site Not Available

  • empty

    St. Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Cheras, 56000
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kota Bharu, Kelantan, 16150
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Selangor, 46150
    Malaysia

    Site Not Available

  • empty

    Ankara, 34740
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Antalya, 07050
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Denizli, 20070
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Gaziantep, 27070
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Hatay, 31040
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Istanbul, 34752
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Goodyear, Arizona 85395
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenbrae, California 94904
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spring Valley, California 91978
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Avon, Illinois 46123
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Crystal Lake, Illinois 60012
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Slidell, Louisiana 70461-4231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waltham, Massachusetts 02453
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toms River, New Jersey 08755-8050
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albany, New York 12206
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75251
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin 53144
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.