NCT00697450

Brief Summary

This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

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
18 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

1.4 years

First QC Date

June 11, 2008

Last Update Submit

November 22, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Weight effect

    12 months prior to and 12 months after detemir treatment.

Secondary Outcomes (2)

  • Improvement in FPG levels

    12 months prior and 12 months after detemir treatment

  • Improvement in HbA1c levels

    12 months prior and 12 months after detemir treatment

Study Arms (1)

All participants

Drug: insulin detemir

Interventions

insulin detemirDRUG

Start dose, frequency of dosing, dose titration to be prescribed by the physician as a result of a normal clinical evaluation

All participants

Eligibility Criteria

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

Type 2 diabetics

You may qualify if:

  • Type 2 diabetes
  • Current treatment with insulin NPH or glargine
  • The selection of the subjects will be at the discretion of the individual physician

You may not qualify if:

  • Current treatment with insulin detemir
  • Previous enrolment in this study
  • Hypersensitivity to insulin detemir or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Prague, 16000, Czechia

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
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

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

CZ(1)