Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

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

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

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

  • Finland
      • Helsinki, Finland, 00250
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
      • Pori, Finland, 28500
        • Novo Nordisk Investigational Site
      • Vantaa, Finland, 01400
        • Novo Nordisk Investigational Site
  • France
      • ANGERS cedex 09, France, 49033
        • Novo Nordisk Investigational Site
      • Antibes, France, 06600
        • Novo Nordisk Investigational Site
      • Brest, France, 29609
        • Novo Nordisk Investigational Site
      • GRENOBLE cedex, France, 38043
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Mougins, France, 06250
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31054
        • Novo Nordisk Investigational Site
  • Germany
      • Alsdorf, Germany, 52477
        • Novo Nordisk Investigational Site
      • Bad Kreuznach, Germany, 55545
        • Novo Nordisk Investigational Site
      • Dormagen, Germany, 41539
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Flensburg, Germany, 24939
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Genthin, Germany, 39307
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20251
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 21073
        • Novo Nordisk Investigational Site
      • Herrenberg, Germany, 71083
        • Novo Nordisk Investigational Site
      • Kippenheim, Germany, 77971
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Speyer, Germany, 67346
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97072
        • Novo Nordisk Investigational Site
  • Netherlands
      • Almere, Netherlands, 1315 RA
        • Novo Nordisk Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Capelle a/d IJssel, Netherlands, 2906 ZC
        • Novo Nordisk Investigational Site
      • Dordrecht, Netherlands, 3318 AT
        • Novo Nordisk Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Novo Nordisk Investigational Site
      • Zoetermeer, Netherlands, 2725 NA
        • Novo Nordisk Investigational Site
  • Sweden
      • Norrköping, Sweden, 601 82
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 112 81
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 182 88
        • Novo Nordisk Investigational Site
      • Umeå, Sweden, 901 85
        • Novo Nordisk Investigational Site
      • Växjö, Sweden, 351 85
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
        • Novo Nordisk Investigational Site
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Brighton, United Kingdom, BN2 5BE
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Cosham, United Kingdom, PO6 3LY
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Novo Nordisk Investigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL8 8DQ
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Watford, United Kingdom, WD18 0HB
        • Novo Nordisk Investigational Site
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Huntington Beach, California, United States, 92646
        • Novo Nordisk Investigational Site
      • Inglewood, California, United States, 90301
        • Novo Nordisk Investigational Site
      • Irvine, California, United States, 92618
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33613
        • Novo Nordisk Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119-6100
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Sea Girt, New Jersey, United States, 08750
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • 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

16 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 basal-bolus insulin regimen for more than or equal to 3 months
  • HbA1c less than or equal to 11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Impaired hepatic or renal function
  • Cardiac problems or uncontrolled hypertension

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 1 year trial period
after 1 year trial period

Secondary Outcome Measures

Outcome Measure
Adverse events
Blood glucose
Body weight
Hypoglycemia
Insulin Treatment Satisfaction

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

September 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

October 29, 2004

First Submitted That Met QC Criteria

October 29, 2004

First Posted (Estimate)

November 1, 2004

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1430
  • 2004-000086-35 (EudraCT Number)

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.

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