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)

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source 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.

Overall Status Completed
Start Date January 2008
Completion Date June 2010
Primary Completion Date June 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of serious adverse drug reactions, including major hypoglycaemic events after 6 month treatment
Secondary Outcome
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
Enrollment 159
Condition
Intervention

Intervention Type: Drug

Intervention Name: insulin detemir

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

Arm Group Label: A

Other Name: Levemir®

Eligibility

Sampling Method: Non-Probability Sample

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®

Gender: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility: Novo Nordisk Investigational Site
Location Countries

Sweden

Verification Date

January 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: A

Acronym PREDICTIVE™
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov