Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

February 22, 2017 updated by: Novo Nordisk A/S

A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

292

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

  • Denmark
      • Esbjerg, Denmark, 6700
        • Novo Nordisk Investigational Site
      • Herning, Denmark, 7400
        • Novo Nordisk Investigational Site
      • Holbæk, Denmark, 4300
        • Novo Nordisk Investigational Site
      • Næstved, Denmark, 4700
        • Novo Nordisk Investigational Site
      • Randers, Denmark
        • Novo Nordisk Investigational Site
      • Silkeborg, Denmark, 8600
        • Novo Nordisk Investigational Site
      • Skive, Denmark, 7800
        • Novo Nordisk Investigational Site
      • Viborg, Denmark
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Norway
      • Bekkestua, Norway, 1357
        • Novo Nordisk Investigational Site
      • Bergen, Norway, NO-5012
        • Novo Nordisk Investigational Site
      • Haugesund, Norway
        • Novo Nordisk Investigational Site
      • Hønefoss, Norway
        • Novo Nordisk Investigational Site
      • Moelv, Norway
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0370
        • Novo Nordisk Investigational Site
      • Tromsø, Norway, 9038
        • Novo Nordisk Investigational Site
      • Vennesla, Norway
        • Novo Nordisk Investigational Site
      • Åsgårdstrand, Norway
        • Novo Nordisk Investigational Site
  • Sweden
      • Arvika, Sweden, 671 80
        • Novo Nordisk Investigational Site
      • Avesta, Sweden, 774 82
        • Novo Nordisk Investigational Site
      • Bjuv, Sweden, 267 38
        • Novo Nordisk Investigational Site
      • Broby, Sweden, 280 60
        • Novo Nordisk Investigational Site
      • Färgelanda, Sweden, 458 32
        • Novo Nordisk Investigational Site
      • Grästorp, Sweden, 467 22
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 416 85
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 417 17
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 416 65
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 417 02
        • Novo Nordisk Investigational Site
      • Habo, Sweden, 566 32
        • Novo Nordisk Investigational Site
      • Helsingborg, Sweden, 254 57
        • Novo Nordisk Investigational Site
      • Härnösand, Sweden, 871 82
        • Novo Nordisk Investigational Site
      • Hässleholm, Sweden, 281 25
        • Novo Nordisk Investigational Site
      • Jönköping, Sweden, 551 11
        • Novo Nordisk Investigational Site
      • Karlstad, Sweden, 651 85
        • Novo Nordisk Investigational Site
      • Karlstad, Sweden, 652 24
        • Novo Nordisk Investigational Site
      • Kristianstad, Sweden, 291 38
        • Novo Nordisk Investigational Site
      • Kristinehamn, Sweden, 681 80
        • Novo Nordisk Investigational Site
      • Kungsbacka, Sweden, 434 80
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
      • Mellerud, Sweden, 464 30
        • Novo Nordisk Investigational Site
      • Mölndal, Sweden, 431 80
        • Novo Nordisk Investigational Site
      • Norrköping, Sweden, 602 36
        • Novo Nordisk Investigational Site
      • Skövde, Sweden, 541 85
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 116 91
        • Novo Nordisk Investigational Site
      • Säffle, Sweden, 661 81
        • Novo Nordisk Investigational Site
      • Tomelilla, Sweden, 273 34
        • Novo Nordisk Investigational Site
      • Torsby, Sweden, 685 29
        • Novo Nordisk Investigational Site
      • Trollhättan, Sweden, 461 40
        • Novo Nordisk Investigational Site
      • Trollhättan, Sweden, 461 85
        • Novo Nordisk Investigational Site
      • Tyresö, Sweden, 135 21
        • Novo Nordisk Investigational Site
      • Uddevalla, Sweden, 451 80
        • Novo Nordisk Investigational Site
      • Värnamo, Sweden, 331 85
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 702 15
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 703 51
        • Novo Nordisk Investigational Site
      • Östersund, Sweden, 831 83
        • Novo Nordisk Investigational Site
      • Östersund, Sweden, 831 62
        • 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 24 months
  • Insulin treatment for the pase 3 months
  • HbA1c (glycosylated haemoglobin) below 13%
  • BMI (Body Mass Index) below 40 kg/m^2
  • Ability and willingness to perform self-blood glucose monitoring

Exclusion Criteria:

  • Receipt of any investigational drug within 4 weeks prior to this trial
  • Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
  • Total daily insulin dosage less than or equal to 1.8 IU/kg

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: biphasic human insulin
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
Experimental: A
Drug: biphasic insulin aspart
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycolated haemoglobin)

Secondary Outcome Measures

Outcome Measure
Prandial increment in blood glucose
7-point blood glucose profile
Number and severity of adverse events
Number and severity of local tolerability issues at the injection site
Number and severity of hypoglycaemic episodes

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.

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 (Actual)

August 19, 2002

Primary Completion (Actual)

May 15, 2003

Study Completion (Actual)

May 15, 2003

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1394

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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