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COMPLETEDPHASE3

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

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

NCT01467375•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

Locations (12)

Novo Nordisk Investigational Site

Broadmeadow, New South Wales, Australia

Novo Nordisk Investigational Site

Parkville, Victoria, Australia

Novo Nordisk Investigational Site

Ashford, Australia

Novo Nordisk Investigational Site

Auchenflower, Australia

Novo Nordisk Investigational Site

Launceston, Australia

Novo Nordisk Investigational Site

Nowra, Australia

Novo Nordisk Investigational Site

Ringwood, Australia

Novo Nordisk Investigational Site

Rooty Hill, Australia

Novo Nordisk Investigational Site

Hull, Canada

Novo Nordisk Investigational Site

London, Canada

Key Dates

Start Date

January 8, 2001

Primary Completion Date

October 22, 2004

Completion Date

October 22, 2004

Last Updated

February 24, 2017

Enrollment

89

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

biphasic insulin aspart

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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