NCT00665093

Brief Summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,569

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

May 1, 2007

Completed
8 months 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
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

April 22, 2008

Last Update Submit

January 6, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    at 24 weeks

Secondary Outcomes (1)

  • FPG, PG profile, weight, % of subjects on target

    at 24 weeks

Study Arms (2)

A

Drug: biphasic insulin aspart 30

B

Drug: insulin detemir

Interventions

biphasic insulin aspart 30DRUG

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Also known as: NovoMix® 30, BIASP
A
insulin detemirDRUG

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

B

Eligibility Criteria

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

Type 1 and Type 2 diabetes mellitus

You may qualify if:

  • Levemir® above 6 yrs
  • NovoMix® 30 above 18 yrs
  • Patients with Type 1 or Type 2 diabetes, including newly diagnosed

You may not qualify if:

  • Current treatment with NovoMix® 30 or Levemir®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Skopje, MK-1000, North Macedonia

Location

Related Publications (1)

  • Milenkovic T. Significant Improvements in Glycemic Control with BIAsp 30 in Clinical Reality: Experience from clinical practice in Macedonia. ADA American Diabetes Association 2009; Country: USA City: New Orleans

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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

April 22, 2008

First Posted

April 23, 2008

Study Start

May 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

NO(1)