Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

January 27, 2017 updated by: Novo Nordisk A/S

Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

503

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

  • Denmark
      • Aalborg, Denmark, 9000
        • Novo Nordisk Investigational Site
      • Esbjerg, Denmark, 6700
        • Novo Nordisk Investigational Site
      • Glostrup, Denmark, 2600
        • Novo Nordisk Investigational Site
      • Herlev, Denmark, 2730
        • Novo Nordisk Investigational Site
      • Hillerød, Denmark, 3400
        • Novo Nordisk Investigational Site
      • Hjørring, Denmark, 9800
        • Novo Nordisk Investigational Site
      • Horsens, Denmark, 8700
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • København, Denmark, 2400
        • Novo Nordisk Investigational Site
      • København S, Denmark, 2300
        • Novo Nordisk Investigational Site
      • Næstved, Denmark, 4700
        • Novo Nordisk Investigational Site
      • Roskilde, Denmark, 4000
        • Novo Nordisk Investigational Site
  • France
      • Bagnols-sur-ceze, France, 30200
        • Novo Nordisk Investigational Site
      • Besancon, France, 25030
        • Novo Nordisk Investigational Site
      • Carcassonne, France, 11000
        • Novo Nordisk Investigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • DAX, France, 40107
        • Novo Nordisk Investigational Site
      • MONTPELLIER cedex 5, France, 34295
        • Novo Nordisk Investigational Site
      • Quimper, France, 29107
        • Novo Nordisk Investigational Site
      • Rueil-malmaison, France, 92501
        • Novo Nordisk Investigational Site
      • Tours, France, 37044
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Italy
      • Cagliari, Italy, 09134
        • Novo Nordisk Investigational Site
      • Catania, Italy, 95126
        • Novo Nordisk Investigational Site
      • Genova, Italy, 16132
        • Novo Nordisk Investigational Site
      • Messina, Italy, 98123
        • Novo Nordisk Investigational Site
      • Monza, Italy, 20052
        • Novo Nordisk Investigational Site
      • Napoli, Italy, 80131
        • Novo Nordisk Investigational Site
      • Parma, Italy, 43100
        • Novo Nordisk Investigational Site
      • Pescara, Italy, 65124
        • Novo Nordisk Investigational Site
      • Prato, Italy, 59100
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00161
        • Novo Nordisk Investigational Site
      • Torino, Italy, 10126
        • Novo Nordisk Investigational Site
      • Treviso, Italy, 31100
        • Novo Nordisk Investigational Site
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Novo Nordisk Investigational Site
      • Den Bosch, Netherlands, 5216 GC
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2584 HV
        • Novo Nordisk Investigational Site
      • Etten-Leur, Netherlands, 4872 LP
        • Novo Nordisk Investigational Site
      • Roelofarendsveen, Netherlands, 2371 RB
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3082 DC
        • Novo Nordisk Investigational Site
      • Vlodrop, Netherlands, 6063 DA
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • Novo Nordisk Investigational Site
      • Bergen, Norway, NO-5012
        • Novo Nordisk Investigational Site
      • Elverum, Norway, 2408
        • Novo Nordisk Investigational Site
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2212
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0586
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0370
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, NO-7030
        • Novo Nordisk Investigational Site
  • Spain
      • Alcorcón, Spain, 28922
        • Novo Nordisk Investigational Site
      • Almería, Spain, 04009
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08017
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08025
        • Novo Nordisk Investigational Site
      • Bilbao, Spain, 48013
        • Novo Nordisk Investigational Site
      • Cádiz, Spain, 11009
        • Novo Nordisk Investigational Site
      • Getafe, Spain, 28905
        • Novo Nordisk Investigational Site
      • Gijón, Spain, 33206
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07198
        • Novo Nordisk Investigational Site
      • Pamplona, Spain, 31008
        • Novo Nordisk Investigational Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Novo Nordisk Investigational Site
      • Santiago de Compostela, Spain, 15706
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
      • Valladolid, Spain, 47011
        • Novo Nordisk Investigational Site
      • Valladolid, Spain, 47010
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Novo Nordisk Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85205
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85029
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Fullerton, California, United States, 92835
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92869
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Novo Nordisk Investigational Site
      • Waltham, Massachusetts, United States, 02453
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89030
        • Novo Nordisk Investigational Site
    • New York
      • Lewiston, New York, United States, 14092
        • Novo Nordisk Investigational Site
      • Williamsville, New York, United States, 14221
        • Novo Nordisk Investigational Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45291
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Connellsville, Pennsylvania, United States, 15425
        • Novo Nordisk Investigational Site
      • Lancaster, Pennsylvania, United States, 17601
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Texas
      • Conroe, Texas, United States, 77384
        • Novo Nordisk Investigational Site
      • Killeen, Texas, United States, 76543
        • 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 at least 12 months
  • Currently treated with Oral Antidiabetic Drugs
  • BMI lesser than or equal to 40 kg/m2
  • HbA1c greater than or equal 7.5 and lesser than or equal to 11%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial

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 20 weeks
after 20 weeks

Secondary Outcome Measures

Outcome Measure
Adverse events
Blood glucose
Hypoglycemia
body weight

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

February 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

February 23, 2005

First Submitted That Met QC Criteria

February 23, 2005

First Posted (Estimate)

February 24, 2005

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1632
  • 2004-001461-18 (EudraCT Number)

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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