NCT01704378|CompletedPhase 4

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

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

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

BIASP-1386

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredOct 2012

StartedApr 2001

CompletionMar 2003

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline

Completed

Started Apr 2001

Typical duration for phase_4 diabetes

Geographic Reach

4 countries

17 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

April 18, 2001

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2003

Completed

9.6 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed

Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

October 8, 2012

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Number of Hypoglycaemic episodes
Occurrence of adverse events

Secondary Outcomes (3)

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

Study Arms (1)

BIAsp

EXPERIMENTAL

Drug: biphasic insulin aspart

Interventions

biphasic insulin aspartDRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal

BIAsp

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.