Observational Study to Observe the Safety of Levemir® Tre... | NCT00704574

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

NCT00704574

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

159Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin detemir

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 23, 2008

First Submission Date that Met QC Criteria

Jun 23, 2008

First Posted Date

Jun 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: insulin detemir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	No extra intervention, only normal clinical practise for treatment of type 1 diabetes	A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of all hypoglycaemic events		after 6 month treatment
Number of adverse drug reactions		after 6 month treatment
BMI changes

Other Outcomes

Not provided

Eligibility Module

Eligibility 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®

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children Age 6 - 18 with type 1 diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Lund		221 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23448369	Result	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2