Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes

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

An Open Label, Non Comparative, Multicentre Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Who Have Completed BIAsp-1234

This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

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

  • Australia
      • Ashford, Australia, 5035
        • Novo Nordisk Investigational Site
      • Auchenflower, Australia, 4066
        • Novo Nordisk Investigational Site
      • Launceston, Australia, 7250
        • Novo Nordisk Investigational Site
      • Nowra, Australia, 2540
        • Novo Nordisk Investigational Site
      • Ringwood, Australia, 3134
        • Novo Nordisk Investigational Site
      • Rooty Hill, Australia, 2766
        • Novo Nordisk Investigational Site
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • Novo Nordisk Investigational Site
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Novo Nordisk Investigational Site
  • Canada
      • Hull, Canada, J8Y 1W1
        • Novo Nordisk Investigational Site
      • London, Canada, N6A 4L6
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G1V 4G2
        • Novo Nordisk Investigational Site
      • Saskatoon, Canada, S7N 0W8
        • 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:

  • Subjects must have been correctly included in and completed BIAsp-1234

Exclusion Criteria:

  • Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial
  • Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234.
  • Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)
  • Known or suspected allergy to trial product or related products
  • Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: biphasic insulin aspart
Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Occurrence of adverse events
Frequency of hypoglycaemic episodes

Secondary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)

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)

January 8, 2001

Primary Completion (Actual)

October 22, 2004

Study Completion (Actual)

October 22, 2004

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-1361

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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