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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 23, 2008

Last Updated Date

April 1, 2009

Start Date ^†

January 2008

Current Primary Outcome Measures ^†

Incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: after 6 month treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00704574 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Number of all hypoglycaemic events [ Time Frame: after 6 month treatment ] [ Designated as safety issue: No ]
Number of adverse drug reactions [ Time Frame: after 6 month treatment ] [ Designated as safety issue: Yes ]
BMI changes [ Time Frame: after 6 month treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 6 month treatment ] [ Designated as safety issue: No ]
Variability in FPG (Fasting Plasma Glucose) [ Time Frame: after 6 month treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes

Brief Summary

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

Study Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Prospective

Condition ^†

Diabetes Mellitus, Type 1

Intervention ^†

Drug: insulin detemir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

200

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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®

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Location Countries ^†

Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00704574

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Secondary IDs ^††

Study Sponsor ^†

Novo Nordisk

Collaborators ^††

Investigators ^†

Study Director:

Karin Enarsson, PhD

Novo Nordisk Scandinavia AB

Information Provided By

Novo Nordisk

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.