Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

Last updated: January 26, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 1

Diabetic Retinopathy

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT01486940
NN304-1374
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months

  • Current treatment with any basal/bolus regimen or any biphasic insulin treatment forat least 6 months

  • BMI below or equal to 35 kg/m^2

  • HbA1c below or equal to 12%

Exclusion

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment

  • Recurrent major hypoglycaemia that may interfere with trial participation (as judgedby the Investigator)

  • Subjects with known hypoglycaemic unawareness as judged by the Investigator

Study Design

Total Participants: 598
Study Start date:
March 01, 2002
Estimated Completion Date:
October 31, 2002

Connect with a study center

  • Novo Nordisk Investigational Site

    Junin,
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Moron,
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Varazdin, 42 000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Hradec Kralove, 50036
    Czech Republic

    Site Not Available

  • Novo Nordisk Investigational Site

    Liberec, 46001
    Czech Republic

    Site Not Available

  • Novo Nordisk Investigational Site

    Plzen - Lochotin, 30460
    Czech Republic

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 10, 10034
    Czech Republic

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 2, 12000
    Czech Republic

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 4, 140 00
    Czech Republic

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 5, 150 18
    Czech Republic

    Site Not Available

  • Novo Nordisk Investigational Site

    Hillerød, 3400
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hjørring, 9800
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Holbæk, 4300
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    København, 2400
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Køge, 4600
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Silkeborg, 8600
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Slagelse, 4200
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Svendborg, 5700
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Århus C, 8000
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Kemi, 94100
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Kokkola, 67200
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Kuopio, 70210
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Oulu, FI-90220
    Finland

    Site Not Available

  • empty

    Pärnu, 80010
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Pärnu, 80010
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Rovaniemi, 96400
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Viljandi, 71024
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Angers,
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    GRENOBLE cedex, 38043
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Lille, 59037
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Lorient, 56322
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    MONTPELLIER cedex 5, 34295
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Mougins, 06250
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Narbonne, 11108
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Paris, 75014
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Poitiers, 86000
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, GR-10552
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Alessandria,
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Asti, 14100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Bari, 70100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Bergamo, 24127
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Catania, 95124
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Genova, 16132
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Lucca, 55100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Milano, 20132
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Padova, 35143
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Prato, 59100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Ravenna, 48121
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Roma, 00161
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Torino, 10126
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Skopje, 1000
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Arendal, 4841
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Gjettum, 1346
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Gjøvik, NO-2819
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Kongsberg, NO-3602
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Kongsvinger, 2212
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Kristiansand S, 4604
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Rådal, 5235
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdansk, 80-211
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Krakow, 31-501
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lodz, 90-030
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lublin, 20-718
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Szczecin, 71-455
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Timisoara, 300736
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 117036
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kosice, 043 80
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Moldava nad Bodvou, 045 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Falun, 791 82
    Sweden

    Site Not Available

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