Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

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

A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236

This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

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

  • Finland
      • Kotka, Finland, 48210
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Lahti, Finland, 15850
        • Novo Nordisk Investigational Site
  • Norway
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Horten, Norway, NO-3188
        • Novo Nordisk Investigational Site
      • Kirkenær, Norway, 2260
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2212
        • Novo Nordisk Investigational Site
      • Notodden, Norway, NO-3675
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site
      • Helsingborg, Sweden, 254 43
        • Novo Nordisk Investigational Site
      • Motala, Sweden, 591 85
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Derby, United Kingdom, DE7 1DY
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2JZ
        • Novo Nordisk Investigational Site
      • Liverpool, United Kingdom, L7 8XP
        • Novo Nordisk Investigational Site
      • Scarborough, United Kingdom, YO12 6QL
        • Novo Nordisk Investigational Site
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • 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:

  • Signed informed consent obtained before any trial-related activities
  • Completed the trial BIAsp-1236

Exclusion Criteria:

  • Planned changes in use of any prescription medication that may interfere with glucose regulation
  • Known or suspected allergy to trial products or related products
  • Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
  • Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator

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: BIAsp
Drug: biphasic insulin aspart
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Occurrence of adverse events
Number of Hypoglycaemic episodes

Secondary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)
Prandial increment in blood glucose
7-point blood glucose profile

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)

April 18, 2001

Primary Completion (Actual)

March 14, 2003

Study Completion (Actual)

March 14, 2003

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 8, 2012

First Posted (Estimate)

October 11, 2012

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-1386

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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