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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00704574

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 1	Drug: insulin detemir

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin detemir No extra intervention, only normal clinical practise for treatment of type 1 diabetes

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children Age 6 - 18 with type 1 diabetes

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®

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704574

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Sweden
	Recruiting
LUND, Sweden, 221 85

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Karin Enarsson, PhD

Novo Nordisk Scandinavia AB

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1920
Study First Received:	June 23, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00704574
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009