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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00704574

Acronym

PREDICTIVE™

Enrollment

159

Registered

2008-06-25

Start date

2008-01-31

Completion date

2010-06-30

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin detemir

No extra intervention, only normal clinical practise for treatment of type 1 diabetes

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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®

Design outcomes

Primary

Measure	Time frame
Incidence of serious adverse drug reactions, including major hypoglycaemic events	after 6 month treatment

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026