Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

February 22, 2017 updated by: Novo Nordisk A/S

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

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

  • Netherlands
      • Amersfoort, Netherlands, 3818 ES
        • Novo Nordisk Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2597 AX
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2566 MJ
        • Novo Nordisk Investigational Site
      • Den Helder, Netherlands, 1782 GZ
        • Novo Nordisk Investigational Site
      • Deventer, Netherlands, 7415 CM
        • Novo Nordisk Investigational Site
      • Enschede, Netherlands, 7511 JX
        • Novo Nordisk Investigational Site
      • Gouda, Netherlands, 2805 AH
        • Novo Nordisk Investigational Site
      • Hoogeveen, Netherlands, 7909 AA
        • Novo Nordisk Investigational Site
      • Leidschendam, Netherlands, 2262 BA
        • Novo Nordisk Investigational Site
      • Meppel, Netherlands, 7943 KA
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3083 AN
        • Novo Nordisk Investigational Site
      • Stadskanaal, Netherlands, 9501 EH
        • Novo Nordisk Investigational Site
      • Utrecht, Netherlands, 3563 AZ
        • Novo Nordisk Investigational Site
      • Waalwijk, Netherlands, 5141 BM
        • Novo Nordisk Investigational Site
      • Weert, Netherlands, 6001 BE
        • Novo Nordisk Investigational Site
      • Zevenaar, Netherlands, 6903 ZN
        • Novo Nordisk Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • 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:

  • Duration of type 1 diabetes for at least 12 months
  • BMI below 35 kg/m2
  • HbA1c between 7.0-12.0%
  • Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
  • Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Previous participation in this trial
  • Receipt of any investigational products within the last 2 months prior to this trial
  • Drug or alcohol dependence
  • Pregnancy, breast-feeding or intention of becoming pregnant

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 26 weeks of treatment
after 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Quality of Life
Incidence of adverse events
Change in body weight
Incidence of hypoglycaemic episodes
Plasma glucose profiles

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.

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 (Actual)

December 2, 2003

Primary Completion (Actual)

October 7, 2004

Study Completion (Actual)

October 7, 2004

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1582

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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