Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

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

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

583

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

  • Austria
      • Ebreichsdorf, Austria, 2483
        • Novo Nordisk Investigational Site
      • Gratwein, Austria, 8112
        • Novo Nordisk Investigational Site
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Neunkirchen, Austria, 2620
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
      • Wien, Austria, A 1160
        • Novo Nordisk Investigational Site
      • Wolfsberg, Austria, 9400
        • Novo Nordisk Investigational Site
  • Belgium
      • Bonheiden, Belgium, 2820
        • Novo Nordisk Investigational Site
      • Brussels, Belgium, 1090
        • 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
  • France
      • Besancon, France, 25030
        • Novo Nordisk Investigational Site
      • Bondy, France, 93143
        • Novo Nordisk Investigational Site
      • Grenoble, France, 38043
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Lyon, France, 69437
        • Novo Nordisk Investigational Site
      • Nantes, France, 44093
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Nimes, France, 30006
        • Novo Nordisk Investigational Site
      • Paris, France, 75877
        • Novo Nordisk Investigational Site
      • Paris Cedex 10, France, 75475
        • Novo Nordisk Investigational Site
      • Poitiers, France, 86000
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67091
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31054
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Kreuznach, Germany, 55545
        • Novo Nordisk Investigational Site
      • Bad Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Bad Neuenahr-Ahrweiler, Germany, 53474
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 13355
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Flensburg, Germany, 24939
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60590
        • Novo Nordisk Investigational Site
      • Freiburg, Germany, 79106
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Furth, Germany, 93437
        • Novo Nordisk Investigational Site
      • Genthin, Germany, 39307
        • Novo Nordisk Investigational Site
      • Giessen, Germany, 35390
        • 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
      • Heidelberg, Germany, 69115
        • Novo Nordisk Investigational Site
      • Krefeld, Germany, 47798
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Marl, Germany, 45770
        • Novo Nordisk Investigational Site
      • München, Germany, 81925
        • Novo Nordisk Investigational Site
      • Neumünster, Germany, 24534
        • Novo Nordisk Investigational Site
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site
      • Nürnberg, Germany, 90402
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Saarbrücken, Germany, 66121
        • Novo Nordisk Investigational Site
      • Schaafheim, Germany, 64850
        • Novo Nordisk Investigational Site
      • Schwabenheim, Germany, 55270
        • Novo Nordisk Investigational Site
      • Schwedt, Germany, 16303
        • 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
  • Ireland
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk Investigational Site
      • Dublin, Ireland
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Barnsley, United Kingdom, S75 2EP
        • Novo Nordisk Investigational Site
      • Bolton, United Kingdom, BL1 4QS
        • Novo Nordisk Investigational Site
      • Bradford, United Kingdom, BD9 6RJ
        • Novo Nordisk Investigational Site
      • Church Village, United Kingdom, CF38 1AB
        • 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, G42 9TY
        • Novo Nordisk Investigational Site
      • Harrow, United Kingdom, HA1 3UJ
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE1 5WW
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE5 4PW
        • Novo Nordisk Investigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE5 9RS
        • Novo Nordisk Investigational Site
      • Newcastle, United Kingdom, NE7 7DN
        • Novo Nordisk Investigational Site
      • Poole, United Kingdom, BH15 2JB
        • Novo Nordisk Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Greenbrae, California, United States, 94904
        • Novo Nordisk Investigational Site
      • La Mesa, California, United States, 91942
        • Novo Nordisk Investigational Site
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68521
        • Novo Nordisk Investigational Site
    • New Jersey
      • Pleasantville, New Jersey, United States, 08232
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Novo Nordisk Investigational Site
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Virginia
      • Warrenton, Virginia, United States, 20186
        • Novo Nordisk Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • 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 2 Diabetes for more than 12 months, and no previous insulin treatment
  • Oral Antidiabetic Drug treatment for at least 4 months
  • Body Mass Index (BMI) less than 40 kg/m2
  • HbA1c 7.5-10.0%

Exclusion Criteria:

  • Current or previous treatment with thiazolidinediones within the last 6 months
  • Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
  • Proliferative retinopathy or maculopathy
  • Known hypoglycaemia unawareness

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 52 weeks
after 52 weeks

Secondary Outcome Measures

Outcome Measure
Change in body weight
Insulin antibodies
Plasma glucose profiles
Incident of hypoglycaemic episodes and adverse events

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, 2003

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

January 27, 2006

First Submitted That Met QC Criteria

January 27, 2006

First Posted (Estimate)

January 30, 2006

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

  • NN304-1373

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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