Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes (EUROMIX)

January 5, 2017 updated by: Novo Nordisk A/S

Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 4

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
      • Feldkirch, Austria, 6807
        • Novo Nordisk Investigational Site
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Horn, Austria, A 3580
        • Novo Nordisk Investigational Site
      • Oberpullendorf, Austria, 7350
        • Novo Nordisk Investigational Site
      • Salzburg, Austria, 5010
        • Novo Nordisk Investigational Site
      • Villach, Austria, A 9500
        • Novo Nordisk Investigational Site
      • Waidhofen a.d. Thaya, Austria, A 3830
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 65691
        • Novo Nordisk Investigational Site
      • Liberec, Czech Republic, 46001
        • Novo Nordisk Investigational Site
  • Germany
      • Augsburg, Germany, 86150
        • Novo Nordisk Investigational Site
      • Castrop-Rauxel, Germany, 44577
        • Novo Nordisk Investigational Site
      • Deggingen, Germany, 73326
        • Novo Nordisk Investigational Site
      • Duisburg, Germany, 47053
        • Novo Nordisk Investigational Site
      • Erlangen, Germany, 91054
        • Novo Nordisk Investigational Site
      • Eschweiler, Germany, 52249
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Fulda, Germany, 36037
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22119
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22177
        • Novo Nordisk Investigational Site
      • Herne, Germany, 44623
        • Novo Nordisk Investigational Site
      • Kippenheim, Germany, 77971
        • Novo Nordisk Investigational Site
      • Lauffen, Germany, 74348
        • Novo Nordisk Investigational Site
      • Leverkusen, Germany, 51377
        • Novo Nordisk Investigational Site
      • Ludwigsburg, Germany, 71634
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67063
        • Novo Nordisk Investigational Site
      • Mannheim, Germany, 68161
        • Novo Nordisk Investigational Site
      • Mannheim, Germany, 68199
        • Novo Nordisk Investigational Site
      • Marburg, Germany, 35037
        • Novo Nordisk Investigational Site
      • Marburg, Germany, 35043
        • Novo Nordisk Investigational Site
      • Mülheim, Germany, 45468
        • Novo Nordisk Investigational Site
      • Neunkirchen, Germany, 66539
        • Novo Nordisk Investigational Site
      • Ostercappeln, Germany, 49179
        • Novo Nordisk Investigational Site
      • Pritzwalk, Germany, 16928
        • Novo Nordisk Investigational Site
      • Rosenheim, Germany, 83022
        • Novo Nordisk Investigational Site
      • Viernheim, Germany, 68519
        • Novo Nordisk Investigational Site
      • Weil der Stadt, Germany, 71263
        • Novo Nordisk Investigational Site
      • Weiskirchen, Germany, 66709
        • Novo Nordisk Investigational Site
      • Witten, Germany, 58452
        • Novo Nordisk Investigational Site
      • Witten, Germany, 58456
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1041
        • Novo Nordisk Investigational Site
      • Eger, Hungary, 3300
        • Novo Nordisk Investigational Site
      • Szekszárd, Hungary, 7100
        • Novo Nordisk Investigational Site
  • Poland
      • Czestochowa, Poland, 42-200
        • Novo Nordisk Investigational Site
      • Gdynia, Poland, 81-366
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20 011
        • Novo Nordisk Investigational Site
      • Otwock, Poland, 05-400
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 61-696
        • Novo Nordisk Investigational Site
  • Slovakia
      • L'ubochna, Slovakia, 03491
        • Novo Nordisk Investigational Site
      • Martin, Slovakia, 036 59
        • Novo Nordisk Investigational Site
  • Slovenia
      • Celje, Slovenia, 3000
        • Novo Nordisk Investigational Site
      • Ljubljana, Slovenia, 1000
        • Novo Nordisk Investigational Site
      • Maribor, Slovenia, 2000
        • 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 6 months
  • Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
  • Previous treatment with oral antidiabetic drugs for at least 4 months
  • Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
  • BMI below 40 kg/m2
  • HbA1c between 7-12%
  • Able and willing to perform self-plasma glucose monitoring

Exclusion Criteria:

  • The receipt of any other investigational drug within 4 weeks before screening
  • A history of drug or alcohol abuse within the last 12 months
  • Severe, uncontrolled hypertension
  • Known or suspected allergy to trial products 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
  • Masking: NONE

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
Time Frame
Change in body mass index
Incidence of hypoglycaemic episodes
Safety profile
HbA1c
Time Frame: after 16 weeks of treatment
after 16 weeks of treatment
Plasma 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

December 1, 2003

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (ESTIMATE)

February 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1564

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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