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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00704574
First received: June 23, 2008
Last updated: June 26, 2012
Last verified: June 2012
  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
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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 ]

Enrollment: 158
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (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
Other Name: Levemir®

  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

Locations
Sweden
Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Karin Enarsson, PhD Novo Nordisk Scandinavia AB
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00704574     History of Changes
Other Study ID Numbers: NN304-1920
Study First Received: June 23, 2008
Last Updated: June 26, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014