Observational Study to Observe the Safety of Levemir® Treatment in Children and Adolescents With Type 1 Diabetes

NCT ID: NCT00704574

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This observational study is conducted in Europe. The trial aims to observe the incidence of serious adverse drug reactions in children and adolescents with type 1 diabetes during Levemir® treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

insulin detemir

Intervention Type DRUG

No extra intervention, only normal clinical practise for treatment of type 1 diabetes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin detemir

No extra intervention, only normal clinical practise for treatment of type 1 diabetes

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Levemir®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent obtained prior to any trial-related activities
* Any patient with diabetes type 1 is eligible for the study, including newly
* The selection of the patients will be at the discretion of the individual physician

Exclusion Criteria

* Type 2 diabetes
* Currently treated with Levemir®
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Lund, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Carlsson A, Forsander G, Ludvigsson J, Larsen S, Ortqvist E; Swedish PREDICTIVE-Youth Study Group. A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes. Pediatr Diabetes. 2013 Aug;14(5):358-65. doi: 10.1111/pedi.12019. Epub 2013 Mar 1.

Reference Type RESULT
PMID: 23448369 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NN304-1920

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Detemir: Role in Type 1 Diabetes
NCT00564395 COMPLETED PHASE4