Comparison of 2 NovoFine® Needles on the Reflux of Insulin | NCT00872560

Studies
Comparison of 2 NovoFine® Needles on the Reflux of Insulin

NCT00872560

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Aug 7, 2018Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 1
Delivery Systems

Interventions

NovoFine® needle 6 mm
NovoFine® needle 8 mm

Countries

Italy

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

Aug 2018

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 20, 1998Actual

Primary Completion Date

Jul 27, 1998Actual

Completion Date

Jul 27, 1998Actual

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Mar 31, 2009Estimated

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

Aug 3, 2018

Last Update Posted Date

Aug 7, 2018Actual

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 trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
NovoFine® needle 6 mm	Device			NEEDLEN
NovoFine® needle 8 mm	Device			NEEDLEN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weighing of reflux of insulin		6 seconds after injection

Secondary Outcomes

Measure	Description	Time Frame
Pain perception		after 6 weeks of treatment
Number and severity of bleedings		after 6 weeks of treatment
Reactions at injection sites

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children/adolescents with type 1 diabetes mellitus
Usage of NovoPen® 1.5 for at least 3 months
Duration of insulin treatment more than 1 year
Normal weight according to Tanner scales
The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%

Exclusion Criteria:

Pregnancy or desire to become pregnant
Clinical relevant peripheral neuropathy as judged by the investigators
Pronounced lipodystrophy in accordance with investigator's evaluation
Use of drugs that can influence the trial
Coagulation disorders (use of anti-coagulants)
Serious, chronic diseases, making it highly unlikely that the subject can complete the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

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		Chieti		66100	Italy

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided