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: August 12, 2014
Last verified: April 2013
  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: 159
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00704574     History of Changes
Other Study ID Numbers: NN304-1920
Study First Received: June 23, 2008
Last Updated: August 12, 2014
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014