Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

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

2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

501

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
      • Buenos Aires, Argentina
        • Novo Nordisk Investigational Site
      • Ciudad Autonoma de Bs As, Argentina, C1405CWB
        • Novo Nordisk Investigational Site
      • Ciudad Autónoma de BsAs, Argentina, C1406FWY
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7602CBM
        • Novo Nordisk Investigational Site
  • Australia
      • Darlinghurst, Australia, 2010
        • Novo Nordisk Investigational Site
      • Melbourne, Australia, 3000
        • Novo Nordisk Investigational Site
      • Stones Corner, Australia, 4120
        • Novo Nordisk Investigational Site
      • Woodville, Australia, 5011
        • Novo Nordisk Investigational Site
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Novo Nordisk Investigational Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Novo Nordisk Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1431
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • India
      • Chennai, India, 600-013
        • Novo Nordisk Investigational Site
      • Hyderabad, India, 600034
        • Novo Nordisk Investigational Site
      • Mumbai, India, 400 0067
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 020042
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 020475
        • Novo Nordisk Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 27 51
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 27 11
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 27 21
        • Novo Nordisk Investigational Site
  • Turkey
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34390
        • 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
  • Currently on basal-bolus regimen
  • BMI = 35.0 kg/m2
  • HbA1c =11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Cardial problems
  • Uncontrolled hypertension
  • Impaired hepatic or renal function

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 a two-year trial period
after a two-year trial period

Secondary Outcome Measures

Outcome Measure
Adverse events
Blood glucose
Hypoglycaemia
Body weight
Body composition
Antibodies

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

June 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

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

  • NN304-1595

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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