NCT01486875

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,155

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

December 5, 2011

Last Update Submit

January 5, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Incidence of serious adverse drug reactions (SADRs)

    Week 26

  • Incidence of major hypoglycaemic events

    Week 26

Secondary Outcomes (3)

  • Number of all hypoglycaemic events

    In the 4 weeks prior to week 12 and week 26, respectively

  • HbA1c (glycosylated haemoglobin A1c)

    Week 26

  • Fasting Plasma Glucose (FPG)

    Week 26

Study Arms (1)

BIAsp 30

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily

BIAsp 30

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate

You may qualify if:

  • Subjects with type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Lund, 221 85, Sweden

Location

Related Publications (1)

  • Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M; Swedish BIAsp Study Group. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes. 2011 Jul;5(2):89-94. doi: 10.1016/j.pcd.2011.02.003. Epub 2011 Mar 26.

    PMID: 21440523RESULT

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

December 5, 2011

First Posted

December 7, 2011

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

SE(1)