A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus

Last updated: June 3, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Diabetic Neuropathy

Diabetic Vitreous Hemorrhage

Treatment

N/A

Clinical Study ID

NCT01835431
NN5401-3816
2012-003566-41
U1111-1133-0958
PIP no. be confirmed
  • Ages 1-17
  • All Genders

Study Summary

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Informed consent obtained before any trial related activities. Trialrelated activities are any procedures that are carried out as part of the trial, includingactivities to determine suitability for the trial - Subjects diagnosed with type 1 diabetes

Exclusion

mellitus - HbA1c below or equal to 11.0% Exclusion Criteria: - Known hypoglycaemicunawareness or recurrent severe hypoglycaemic events as judged by the investigator - Morethan 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 monthsprior to Visit 1 (Screening) - Any chronic disorder or significant concomitant disease,which in the investigator's opinion might jeopardise the subject's safety or compliancewith the protocol

Study Design

Total Participants: 362
Study Start date:
October 17, 2013
Estimated Completion Date:
November 07, 2014

Connect with a study center

  • Novo Nordisk Investigational Site

    Brussels, 1090
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Curitiba, Parana 80810-040
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Porto Alegre, Rio Grande Do Sul 91350-250
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    São Paulo, Sao Paulo 01228-200
    Brazil

    Site Not Available

  • Novo Nordisk Investigational Site

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Mississauga, Ontario L5B 1B8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Zagreb, 10000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Pardubice, 53203
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Prague 5, 15018
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka 560034
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra 400012
    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

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Haifa, 31096
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah Tikva, 49202
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Aviv,
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Zerifin, 70300
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Skopje, 1000
    North Macedonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdansk, 80-952
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, 04-736
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 125373
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630048
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 191144
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Ufa, 450106
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgrade, 11070
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Nis, 18 000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ljubljana, 1525
    Slovenia

    Site Not Available

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Mayville, KwaZulu-Natal 4058
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Esplugues Llobregat(Barcelona), 08950
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Leganés, 28911
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Madrid, 28046
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sacramento, California 95816
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Maitland, Florida 32751
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30339
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Idaho Falls, Idaho 83404-7596
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Springfield, Illinois 62703
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buffalo, New York 14203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75231
    United States

    Site Not Available

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