Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Jan 2001

Longer than P75 for phase_3 diabetes

Geographic Reach

2 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

Study Start

First participant enrolled

January 8, 2001

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2004

Completed

7 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed

Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

3.8 years

First QC Date

November 4, 2011

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Occurrence of adverse events
Frequency of hypoglycaemic episodes

Secondary Outcomes (1)

HbA1c (glycosylated haemoglobin)

Study Arms (1)

A

EXPERIMENTAL

Drug: biphasic insulin aspart

Interventions

biphasic insulin aspartDRUG

Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.