Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

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

Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

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

  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • France
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Rennes, France, 35056
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Heilbrunn, Germany, 83670
        • Novo Nordisk Investigational Site
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site
      • Schaafheim, Germany, 64850
        • Novo Nordisk Investigational Site
      • Schwedt, Germany, 16303
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Wiesbaden, Germany, 65183
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97072
        • Novo Nordisk Investigational Site
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
  • Netherlands
      • Beverwijk, Netherlands, 1942 LE
        • Novo Nordisk Investigational Site
      • Delft, Netherlands, 2625 AD
        • Novo Nordisk Investigational Site
      • Eindhoven, Netherlands, 5631 BM
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3011 TD
        • Novo Nordisk Investigational Site
  • Poland
      • Lodz, Poland, 90-030
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-718
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 71-455
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 03-242
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • Romania
      • Constanta, Romania, 900591
        • Novo Nordisk Investigational Site
      • Iasi, Romania, 700111
        • Novo Nordisk Investigational Site
      • Timisoara, Romania, 300736
        • Novo Nordisk Investigational Site
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400006
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119435
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194291
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novo Nordisk Investigational Site
  • Spain
      • Córdoba, Spain, 14004
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28040
        • Novo Nordisk Investigational Site
      • Orihuela, Spain, 03300
        • Novo Nordisk Investigational Site
      • Sabadell, Spain, 08208
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
      • Valladolid, Spain, 47011
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 416 85
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 581 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Mölndal, Sweden, 431 80
        • Novo Nordisk Investigational Site
      • Uppsala, Sweden, 751 85
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Novo Nordisk Investigational Site
      • Brighton, United Kingdom, BN2 5BE
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV6 2FL
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G42 9TY
        • Novo Nordisk Investigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL8 8DQ
        • Novo Nordisk Investigational Site
      • York, United Kingdom, YO3 7HE
        • 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
  • Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
  • HbA1c between 8.0-10.5%
  • Body mass index (BMI) below 35.0 kg/m2
  • Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria:

  • Total daily insulin dose of 1.80 IU/kg or more
  • Known or suspected allergy to trial product or related products
  • Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

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 4 months of treatment
after 4 months of treatment

Secondary Outcome Measures

Outcome Measure
8-point blood glucose profile
incidence of hypoglycaemic episodes
safety profiles
changes in body weight and vital signs

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

January 1, 2004

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 25, 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-1486

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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