NCT00696995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

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, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

June 11, 2008

Last Update Submit

January 6, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • The number of serious adverse drug reactions, including major hypoglycaemic events

    at 26 weeks

Secondary Outcomes (3)

  • The number of all hypoglycaemic events

    at 26 weeks

  • HbA1c

    at 12 weeks and 26 weeks

  • Fasting plasma glucose at visits

    at 12 weeks and 26 weeks

Study Arms (1)

A

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation

Also known as: NovoMix® 30
A

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with type 2 diabetes.

You may qualify if:

  • Patients with Type 2 diabetes
  • Insulin-naive or previously treated by basal only insulin therapy

You may not qualify if:

  • Patients who are unlikely to comply with the protocol
  • Pregnancy or breastfeeding or intention of becoming pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Lahti, 15110, Finland

Location

Related Publications (1)

  • Makela JK, Schmuser C, Askonen K, Saukkonen T. Starting or switching to biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes: a multicenter, observational, primary care study conducted in Finland. Diabetes Res Clin Pract. 2012 Jan;95(1):10-8. doi: 10.1016/j.diabres.2011.06.006. Epub 2011 Nov 9.

    PMID: 22078072RESULT

Related Links

Biospecimen

Retention: NONE RETAINED

Venous blood samples drawn as part of routine clinical evaluation

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

June 11, 2008

First Posted

June 13, 2008

Study Start

January 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

FI(1)