NCT01536626

Brief Summary

This study is conducted in Europe. The aim of this observational study is to observe and investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic insulin aspart 30/70 (BIAsp 30) in an outpatient setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 9, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2007

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

February 16, 2012

Last Update Submit

February 22, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c (glycosylated haemoglobin)

Secondary Outcomes (3)

  • Number of hypoglycaemic events

  • Treatment satisfaction: ITSQ (Insulin Treatment Satisfaction Questionnaire)

  • Quality of Life (QoL) using the World Health Organization Wellbeing Index (WHO-5)

Study Arms (1)

BIAsp 30 users

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Prescription at the discretion of the treating physician

BIAsp 30 users

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 2 diabetes treated with BHI 30 who have been by the physician for some reason switched to BIAsp 30

You may qualify if:

  • Type 2 diabetic subjects treated with BHI 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

June 9, 2006

Primary Completion

April 10, 2007

Study Completion

April 10, 2007

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

NL(1)