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

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin detemir

• Registration Number: NCT00704574
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of adverse drug reactions	after 6 month treatment
BMI changes	after 6 month treatment
HbA1c	after 6 month treatment
Number of all hypoglycaemic events	after 6 month treatment
Variability in FPG (Fasting Plasma Glucose)	after 6 month treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Lund, Sweden