Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes

January 30, 2017 updated by: Novo Nordisk A/S

Efficacy and Safety Comparison of Insulin Detemir and Insulin Glargine Plus Insulin Aspart in Patients With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The purpose of this study is to determine if the use of insulin detemir in combination with insulin aspart is safe and at least as effective as insulin glargine in combination with insulin aspart for the control of blood glucose in patients with Type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

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

  • Canada
      • London, Canada, N6A 5A5
        • Novo Nordisk Investigational Site
      • Mississauga, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Montreal, Canada, H3A 1A1
        • Novo Nordisk Investigational Site
      • Ste-Foy, Canada, G1V 4G5
        • Novo Nordisk Investigational Site
      • Thornhill, Canada, L4J 8L7
        • Novo Nordisk Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Novo Nordisk Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Novo Nordisk Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00921
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Novo Nordisk Investigational Site
      • Vestavia, Alabama, United States, 35209
        • Novo Nordisk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Novo Nordisk Investigational Site
      • Searcy, Arkansas, United States, 72143
        • Novo Nordisk Investigational Site
    • California
      • Chula Vista, California, United States, 91911
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Inglewood, California, United States, 90301
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92868
        • Novo Nordisk Investigational Site
      • Santa Ana, California, United States, 92705
        • Novo Nordisk Investigational Site
      • Santa Barbara, California, United States, 93105
        • Novo Nordisk Investigational Site
      • Santa Monica, California, United States, 90404
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
      • Longmont, Colorado, United States, 80501
        • Novo Nordisk Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19702
        • Novo Nordisk Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Novo Nordisk Investigational Site
      • Delray Beach, Florida, United States, 33484
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
      • Longwood, Florida, United States, 32779
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32804
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30032
        • Novo Nordisk Investigational Site
      • Powder Springs, Georgia, United States, 30127
        • 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
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Novo Nordisk Investigational Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55108
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Novo Nordisk Investigational Site
      • Reno, Nevada, United States, 89502-0111
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
    • New York
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Novo Nordisk Investigational Site
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
      • Monroe, North Carolina, United States, 28204
        • Novo Nordisk Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Novo Nordisk Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Clinton, Oklahoma, United States, 73601
        • Novo Nordisk Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Novo Nordisk Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Novo Nordisk Investigational Site
    • South Carolina
      • Duncan, South Carolina, United States, 29334
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75093
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23294
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23249
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Tacoma, Washington, United States, 98405
        • 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
  • Currently treated with glucose lowering tablets or insulin
  • HbA1c: 7.0-12.0%

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 26 weeks
after 26 weeks

Secondary Outcome Measures

Outcome Measure
Body weight
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.

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, 2005

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

March 22, 2005

First Submitted That Met QC Criteria

March 22, 2005

First Posted (ESTIMATE)

March 23, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-2175

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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