Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

July 17, 2017 updated by: Novo Nordisk A/S

A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

752

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

  • Australia
      • Ashford, Australia, 5035
        • Novo Nordisk INvestigational Site
      • Box Hill, Australia, 3128
        • Novo Nordisk INvestigational Site
      • Clayton, Australia, 3168
        • Novo Nordisk INvestigational Site
      • Garran, Australia, 2605
        • Novo Nordisk INvestigational Site
      • Ringwood, Australia, 3134
        • Novo Nordisk INvestigational Site
      • Stones Corner, Australia, 4120
        • Novo Nordisk INvestigational Site
      • Woodville, Australia, 5011
        • Novo Nordisk INvestigational Site
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • Novo Nordisk INvestigational Site
  • Belgium
      • Bornem, Belgium, 2880
        • Novo Nordisk INvestigational Site
      • Edegem, Belgium, 2650
        • Novo Nordisk INvestigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk INvestigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk INvestigational Site
      • Luxembourg, Belgium, 1210
        • Novo Nordisk INvestigational Site
  • Denmark
      • Fredericia, Denmark, 7000
        • Novo Nordisk INvestigational Site
      • Frederiksberg, Denmark, 2000
        • Novo Nordisk INvestigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk INvestigational Site
      • København, Denmark, 2400
        • Novo Nordisk INvestigational Site
      • Middelfart, Denmark
        • Novo Nordisk INvestigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk INvestigational Site
      • Vejle, Denmark, 7100
        • Novo Nordisk INvestigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk INvestigational Site
  • Finland
      • Espoo, Finland, 02740
        • Novo Nordisk INvestigational Site
      • Helsinki, Finland, 00250
        • Novo Nordisk INvestigational Site
      • Joensuu, Finland, 80210
        • Novo Nordisk INvestigational Site
      • Kemi, Finland, 94100
        • Novo Nordisk INvestigational Site
      • Vantaa, Finland, 01400
        • Novo Nordisk INvestigational Site
  • France
      • ANGERS cedex 09, France, 49033
        • Novo Nordisk INvestigational Site
      • Avignon, France, 84902
        • Novo Nordisk INvestigational Site
      • Bondy, France, 93143
        • Novo Nordisk INvestigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk INvestigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk INvestigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk INvestigational Site
      • MONTPELLIER cedex 5, France, 34295
        • Novo Nordisk INvestigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk INvestigational Site
      • Narbonne, France, 11108
        • Novo Nordisk INvestigational Site
      • Paris, France, 75877
        • Novo Nordisk INvestigational Site
      • Paris, France, 75908
        • Novo Nordisk INvestigational Site
      • Paris Cedex 10, France, 75475
        • Novo Nordisk INvestigational Site
      • Poitiers, France, 86000
        • Novo Nordisk INvestigational Site
      • Rennes, France, 35056
        • Novo Nordisk INvestigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk INvestigational Site
      • Dublin, Ireland
        • Novo Nordisk INvestigational Site
  • Netherlands
      • Amersfoort, Netherlands, 3816 CP
        • Novo Nordisk INvestigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk INvestigational Site
      • Brunssum, Netherlands, 6442 BE
        • Novo Nordisk INvestigational Site
      • Den Haag, Netherlands, 2512 VA
        • Novo Nordisk INvestigational Site
      • Eindhoven, Netherlands, 5631 BM
        • Novo Nordisk INvestigational Site
      • Haarlem, Netherlands, 2012 CE
        • Novo Nordisk INvestigational Site
      • Hengelo, Netherlands, 7555 DL
        • Novo Nordisk INvestigational Site
      • Utrecht, Netherlands, 3582 KE
        • Novo Nordisk INvestigational Site
  • Norway
      • Bergen, Norway, NO-5012
        • Novo Nordisk INvestigational Site
      • Jessheim, Norway, 2050
        • Novo Nordisk INvestigational Site
      • Kongsvinger, Norway, 2226
        • Novo Nordisk INvestigational Site
      • Oslo, Norway, 0407
        • Novo Nordisk INvestigational Site
      • Oslo, Norway, 0284
        • Novo Nordisk INvestigational Site
      • Sarpsborg, Norway, 1702
        • Novo Nordisk INvestigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk INvestigational Site
      • Stord, Norway, 5400
        • Novo Nordisk INvestigational Site
      • Trondheim, Norway, 7006
        • Novo Nordisk INvestigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk INvestigational Site
      • Helsingborg, Sweden, 251 87
        • Novo Nordisk INvestigational Site
      • Karlstad, Sweden, 651 85
        • Novo Nordisk INvestigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk INvestigational Site
      • Skövde, Sweden, 541 85
        • Novo Nordisk INvestigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk INvestigational Site
      • Umeå, Sweden, 901 85
        • Novo Nordisk INvestigational Site
      • Uppsala, Sweden, 751 85
        • Novo Nordisk INvestigational Site
      • Värnamo, Sweden, 331 85
        • Novo Nordisk INvestigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk INvestigational Site
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
        • Novo Nordisk INvestigational Site
      • Blackburn, United Kingdom, BB3 3LR
        • Novo Nordisk INvestigational Site
      • Bolton, United Kingdom, BL1 4QS
        • Novo Nordisk INvestigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk INvestigational Site
      • Cosham, United Kingdom, PO6 3LY
        • Novo Nordisk INvestigational Site
      • Derby, United Kingdom, DE7 1DY
        • Novo Nordisk INvestigational Site
      • Gillingham, United Kingdom, ME7 5NY
        • Novo Nordisk INvestigational Site
      • Glasgow, United Kingdom, G42 9TY
        • Novo Nordisk INvestigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Novo Nordisk INvestigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk INvestigational Site
      • Kettering, United Kingdom, NN16 8UZ
        • Novo Nordisk INvestigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk INvestigational Site
      • Llantrisant, United Kingdom, CF72 8XR
        • Novo Nordisk INvestigational Site
      • London, United Kingdom, SE1 7EH
        • Novo Nordisk INvestigational Site
      • Newcastle, United Kingdom, NE7 7DN
        • Novo Nordisk INvestigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Novo Nordisk INvestigational Site
      • Norwich, United Kingdom, NR1 3SR
        • Novo Nordisk INvestigational Site
      • Nottingham, United Kingdom, NG5 1PB
        • Novo Nordisk INvestigational Site
      • Oxford, United Kingdom, OX2 6HE
        • Novo Nordisk INvestigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk INvestigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Novo Nordisk INvestigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk INvestigational Site
      • Taunton, United Kingdom, TA1 5DA
        • Novo Nordisk INvestigational Site
      • York, United Kingdom, YO3 7HE
        • 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:

  • Signed and dated informed consent obtained before any trial-related activities
  • Type 1 diabetes diagnosed and classified according to aetiology
  • Duration of type 1 diabetes equal to or more than 12 months
  • Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
  • Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

  • Proliferative retinopathy
  • Total basal insulin dose of more than 100 IU per day
  • Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
  • Known unawareness of hypoglycaemia
  • Previous treatment with insulin detemir

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin detemir
Drug: Insulin detemir
Active Comparator: NPH insulin
Drug: NPH insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in the level of glycosylated haemoglobin(HbA1c)
Time Frame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)

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

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 (Actual)

February 1, 2001

Primary Completion (Actual)

November 12, 2001

Study Completion (Actual)

November 12, 2001

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk Disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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