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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704574
First Posted: June 25, 2008
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 ]

Secondary Outcome Measures:
  • Number of all hypoglycaemic events [ Time Frame: after 6 month treatment ]
  • Number of adverse drug reactions [ Time Frame: after 6 month treatment ]
  • BMI changes [ Time Frame: after 6 month treatment ]
  • HbA1c [ Time Frame: after 6 month treatment ]
  • Variability in FPG (Fasting Plasma Glucose) [ Time Frame: after 6 month treatment ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704574


Locations
Sweden
Novo Nordisk Investigational Site
Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00704574     History of Changes
Other Study ID Numbers: NN304-1920
First Submitted: June 23, 2008
First Posted: June 25, 2008
Last Update Posted: January 31, 2017
Last Verified: January 2017

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 Detemir
Hypoglycemic Agents
Physiological Effects of Drugs