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NCT00704574 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— PREDICTIVE™  

Official title:
Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00704574
Other study ID # NN304-1920
Secondary ID
Status Completed
Phase N/A
First received June 23, 2008
Last updated January 30, 2017
Start date January 2008
Est. completion date June 2010

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 159
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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®

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin detemir
No extra intervention, only normal clinical practise for treatment of type 1 diabetes

Locations
Country Name City State
Sweden Novo Nordisk Investigational Site Lund

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of serious adverse drug reactions, including major hypoglycaemic events after 6 month treatment
Secondary Number of all hypoglycaemic events after 6 month treatment
Secondary Number of adverse drug reactions after 6 month treatment
Secondary BMI changes after 6 month treatment
Secondary HbA1c after 6 month treatment
Secondary Variability in FPG (Fasting Plasma Glucose) after 6 month treatment
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