NCT00872560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jan 1998

Shorter than P25 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 1998

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 1998

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

March 30, 2009

Last Update Submit

August 3, 2018

Conditions

DiabetesDiabetes Mellitus, Type 1Delivery Systems

Outcome Measures

Primary Outcomes (1)

  • Weighing of reflux of insulin

    6 seconds after injection

Secondary Outcomes (3)

  • Pain perception

    after 6 weeks of treatment

  • Number and severity of bleedings

    after 6 weeks of treatment

  • Reactions at injection sites

    after 6 weeks of treatment

Interventions

NovoFine® needle 6 mmDEVICE
Also known as: NEEDLEN
NovoFine® needle 8 mmDEVICE
Also known as: NEEDLEN

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Chieti, 66100, Italy

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

January 20, 1998

Primary Completion

July 27, 1998

Study Completion

July 27, 1998

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

IT(1)