NCT01565733

Brief Summary

This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

March 26, 2012

Last Update Submit

October 27, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Frequency of severe hypoglycaemic episodes

Secondary Outcomes (5)

  • Number of severe hypoglycaemic episodes

  • Number of mild hypoglycaemic episodes

  • Postprandial glucose concentration after breakfast, lunch, and dinner

  • Average fasting glucose concentration after waking and before main meals

  • Average plasma glucose level at bedtime and at night

Study Arms (1)

NovoMix® 30 users

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.

NovoMix® 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 requiring treatment with NovoMix® 30 insulin on admission who before hospitalisation had been treated with oral antidiabetics and/or human insulin

You may qualify if:

  • Patients with type 2 diabetes
  • Treated with oral anti-diabetics and/or human insulin

You may not qualify if:

  • Persons previously included in the trial
  • Hypersensitive to biphasic insulin aspart or any of the excipients
  • Pregnant or lactating women, or those who plan to get pregnant within the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Warsaw, PL-02-274, Poland

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

March 26, 2012

First Posted

March 29, 2012

Study Start

January 1, 2007

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

PL(1)