NCT00657930

Brief Summary

This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

April 8, 2008

Last Update Submit

March 2, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Efficacy (HbA1c)

    24 weeks

Secondary Outcomes (4)

  • Body weight

    24 weeks

  • Hypoglycaemia frequency

    24 weeks

  • FBG variability

    24 weeks

  • Insulin dose change

    24 weeks

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemirDRUG

observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.

Also known as: Levemir®
A

Eligibility Criteria

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

Adult Type 2 Diabetes Mellitus patients on intensive insulin treatment

You may qualify if:

  • Type 2 diabetic subjects on intensive insulin treatment (ICT)
  • Eligibility for once daily insulin detemir administration
  • Informed consent obtained before any observation-related activities

You may not qualify if:

  • Known or suspected allergy to insulin detemir
  • Subjects previously enrolled in the observation
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Budapest, 1025, Hungary

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

HU(1)