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

January 26, 2017 updated by: Novo Nordisk A/S

A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

598

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Junin, Argentina
        • Novo Nordisk Investigational Site
      • Moron, Argentina
        • Novo Nordisk Investigational Site
  • Croatia
      • Varazdin, Croatia, 42 000
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Hradec Kralove, Czech Republic, 50036
        • Novo Nordisk Investigational Site
      • Liberec, Czech Republic, 46001
        • Novo Nordisk Investigational Site
      • Plzen - Lochotin, Czech Republic, 30460
        • Novo Nordisk Investigational Site
      • Praha 10, Czech Republic, 10034
        • Novo Nordisk Investigational Site
      • Praha 2, Czech Republic, 12000
        • Novo Nordisk Investigational Site
      • Praha 4, Czech Republic, 140 00
        • Novo Nordisk Investigational Site
      • Praha 5, Czech Republic, 150 18
        • Novo Nordisk Investigational Site
  • Denmark
      • Hillerød, Denmark, 3400
        • Novo Nordisk Investigational Site
      • Hjørring, Denmark, 9800
        • Novo Nordisk Investigational Site
      • Holbæk, Denmark, 4300
        • Novo Nordisk Investigational Site
      • København, Denmark, 2400
        • Novo Nordisk Investigational Site
      • Køge, Denmark, 4600
        • Novo Nordisk Investigational Site
      • Silkeborg, Denmark, 8600
        • Novo Nordisk Investigational Site
      • Slagelse, Denmark, 4200
        • Novo Nordisk Investigational Site
      • Svendborg, Denmark, 5700
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Finland
      • Kemi, Finland, 94100
        • Novo Nordisk Investigational Site
      • Kokkola, Finland, 67200
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Oulu, Finland, FI-90220
        • Novo Nordisk Investigational Site
      • Pärnu, Finland, 80010
        • Novo Nordisk Investigational Site
      • Rovaniemi, Finland, 96400
        • Novo Nordisk Investigational Site
      • Viljandi, Finland, 71024
        • Novo Nordisk Investigational Site
  • France
      • Angers, France
        • Novo Nordisk Investigational Site
      • GRENOBLE cedex, France, 38043
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • Lorient, France, 56322
        • Novo Nordisk Investigational Site
      • MONTPELLIER cedex 5, France, 34295
        • Novo Nordisk Investigational Site
      • Mougins, France, 06250
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Paris, France, 75877
        • Novo Nordisk Investigational Site
      • Paris, France, 75014
        • Novo Nordisk Investigational Site
      • Paris Cedex 10, France, 75475
        • Novo Nordisk Investigational Site
      • Poitiers, France, 86000
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-115 27
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-10552
        • Novo Nordisk Investigational Site
  • Italy
      • Alessandria, Italy
        • Novo Nordisk Investigational Site
      • Asti, Italy, 14100
        • Novo Nordisk Investigational Site
      • Bari, Italy, 70100
        • Novo Nordisk Investigational Site
      • Bergamo, Italy, 24127
        • Novo Nordisk Investigational Site
      • Catania, Italy, 95124
        • Novo Nordisk Investigational Site
      • Catania, Italy, 95126
        • Novo Nordisk Investigational Site
      • Genova, Italy, 16132
        • Novo Nordisk Investigational Site
      • Lucca, Italy, 55100
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • Padova, Italy, 35143
        • Novo Nordisk Investigational Site
      • Prato, Italy, 59100
        • Novo Nordisk Investigational Site
      • Ravenna, Italy, 48121
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00161
        • Novo Nordisk Investigational Site
      • Torino, Italy, 10126
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Norway
      • Arendal, Norway, 4841
        • Novo Nordisk Investigational Site
      • Gjettum, Norway, 1346
        • Novo Nordisk Investigational Site
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Kongsberg, Norway, NO-3602
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2212
        • Novo Nordisk Investigational Site
      • Kristiansand S, Norway, 4604
        • Novo Nordisk Investigational Site
      • Rådal, Norway, 5235
        • Novo Nordisk Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-822
        • Novo Nordisk Investigational Site
      • Bydgoszcz, Poland, 85-094
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-211
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-501
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 90-030
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-718
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 71-455
        • Novo Nordisk Investigational Site
  • Romania
      • Timisoara, Romania, 300736
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 125315
        • Novo Nordisk Investigational Site
  • Slovakia
      • Kosice, Slovakia, 043 80
        • Novo Nordisk Investigational Site
      • Moldava nad Bodvou, Slovakia, 045 01
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months
  • Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
  • BMI below or equal to 35 kg/m^2
  • HbA1c below or equal to 12%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
  • Subjects with known hypoglycaemic unawareness as judged by the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basal/bolus regimen 1
Drug: insulin detemir
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Drug: insulin aspart
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
Active Comparator: Basal/bolus regimen 2
Drug: insulin NPH
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Drug: human soluble insulin
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Outcome Measure
Incidence of adverse events
8-point blood glucose profiles
Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
Incidence of self-recorded hypoglycaemic episodes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

October 1, 2002

Study Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on insulin detemir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe