Observational Study to Observe the Safety of Levemir® Treatment in Children and Adolescents With Type 1 Diabetes
PREDICTIVE™
Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth)
1 other identifier
observational
159
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 31, 2017
January 1, 2017
2.4 years
June 23, 2008
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of serious adverse drug reactions, including major hypoglycaemic events
after 6 month treatment
Secondary Outcomes (5)
Number of all hypoglycaemic events
after 6 month treatment
Number of adverse drug reactions
after 6 month treatment
BMI changes
after 6 month treatment
HbA1c
after 6 month treatment
Variability in FPG (Fasting Plasma Glucose)
after 6 month treatment
Study Arms (1)
A
Interventions
No extra intervention, only normal clinical practise for treatment of type 1 diabetes
Eligibility Criteria
Children Age 6 - 18 with type 1 diabetes
You may qualify if:
- 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
You may not qualify if:
- Type 2 diabetes
- Currently treated with Levemir®
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Lund, 221 85, Sweden
Related Publications (1)
Carlsson A, Forsander G, Ludvigsson J, Larsen S, Ortqvist E; Swedish PREDICTIVE-Youth Study Group. A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes. Pediatr Diabetes. 2013 Aug;14(5):358-65. doi: 10.1111/pedi.12019. Epub 2013 Mar 1.
PMID: 23448369RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 25, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
January 31, 2017
Record last verified: 2017-01