Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

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

Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

477

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

  • Belgium
      • Arlon, Belgium, 6700
        • Novo Nordisk Investigational Site
      • Gilly, Belgium, 6060
        • Novo Nordisk Investigational Site
      • Huy, Belgium, 4500
        • Novo Nordisk Investigational Site
      • Jumet, Belgium, 6040
        • Novo Nordisk Investigational Site
  • Croatia
      • Rijeka, Croatia, 51 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • Denmark
      • Hjørring, Denmark, 9800
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • Kalundborg, Denmark, 4400
        • Novo Nordisk Investigational Site
      • København, Denmark, 2400
        • Novo Nordisk Investigational Site
      • København S, Denmark, 2300
        • Novo Nordisk Investigational Site
      • Køge, Denmark, 4600
        • Novo Nordisk Investigational Site
      • Slagelse, Denmark, 4200
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • France
      • Amiens, France
        • Novo Nordisk Investigational Site
      • Auxerre, France, 89000
        • Novo Nordisk Investigational Site
      • Avignon, France, 84902
        • Novo Nordisk Investigational Site
      • DAX, France, 40107
        • Novo Nordisk Investigational Site
      • Evry, France, 91014
        • Novo Nordisk Investigational Site
      • Mougins, France, 06250
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Rueil-Malmaison, France, 92501
        • Novo Nordisk Investigational Site
      • Valenciennes, France, 59322
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Norway
      • Bekkestua, Norway, 1357
        • Novo Nordisk Investigational Site
      • Bergen, Norway, NO-5012
        • Novo Nordisk Investigational Site
      • Elverum, Norway, 2408
        • Novo Nordisk Investigational Site
      • Gjettum, Norway, 1346
        • Novo Nordisk Investigational Site
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Jessheim, Norway, 2050
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0370
        • Novo Nordisk Investigational Site
      • Rådal, Norway, 5235
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
  • Poland
      • Gniewkowo, Poland, 88-140
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-261
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 90-030
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-718
        • Novo Nordisk Investigational Site
      • Rawa Mazowiecka, Poland, 96-200
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 71-455
        • Novo Nordisk Investigational Site
      • Tychy, Poland, 43-100
        • Novo Nordisk Investigational Site
      • Warsaw, Poland, 01-809
        • Novo Nordisk Investigational Site
      • Warsaw, Poland, 01-877
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-097
        • Novo Nordisk Investigational Site
      • Wolomin, Poland, 05-200
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119435
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 123448
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 127411
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 198013
        • Novo Nordisk Investigational Site
  • Slovakia
      • Trencin, Slovakia, 91171
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site
      • Grästorp, Sweden, 467 22
        • Novo Nordisk Investigational Site
      • Kristianstad, Sweden, 291 85
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 581 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 223 70
        • Novo Nordisk Investigational Site
      • Trelleborg, Sweden, 231 85
        • Novo Nordisk Investigational Site
      • Umeå, Sweden, 901 85
        • 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 since diagnosis
  • Insulin naive subjects
  • OAD treatment for at least 4 months alone or combined with no more than two OADs
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-10.0%
  • Able and willing to use twice a day injections for the entire trial period

Exclusion Criteria:

  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 6 months
  • Acute insulin treatment for longer than 7 days in a row within the last 6 months
  • Secondary diabetes
  • Known maturity onset of diabetes of young (MODY)
  • Known or suspected allergy to trial product or related products

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
Incidence of adverse events
Body weight
Within-subject variation
Fasting plasma glucose
Incidence of total hypoglycaemic episodes
Insulin 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

March 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 30, 2008

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

  • NN304-1530

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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