Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00894270




Registration number
NCT00894270
Ethics application status
Date submitted
5/05/2009
Date registered
6/05/2009
Date last updated
8/05/2009

Titles & IDs
Public title
Comparison of Vehicle Delivery Depth Using the NovoFine® 5 mm Needle With or Without a Skin Fold and Inserted at Either 45 or 90 Degrees
Scientific title
Comparison of Vehicle Delivery Depth Using the NovoFine® 5 mm Needle With or Without a Skin Fold and Inserted at Either 45 or 90 Degrees
Secondary ID [1] 0 0
Novofine002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Sterile air injection
Treatment: Surgery - Placebo injection
Treatment: Devices - Novofine needle

Treatment: Surgery: Sterile air injection
Injection of 20 microlitres using Novofine 5mm needle of sterile air into either abdomen or thigh using either a pinched or unpinched skin fold and either a vertical or angled approach.

Treatment: Surgery: Placebo injection
Injection of either 20, 40 or 60 IU of placebo media into either abdomen or thigh using either a vertical or angled Novofine 5 mm needle. Leakage of fluid will be blotted and then weighed to establish fluid loss.

Treatment: Devices: Novofine needle
Novofine 5mm needle
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the safety and effectiveness of 5 mm needles using either thigh or abdomen and either a pinched or unpinched skin fold.
Timepoint [1] 0 0
Assessed at the time of the injection
Secondary outcome [1] 0 0
Examine leakage of placebo medium from thigh or abdomen.
Timepoint [1] 0 0
Immediately following the injection
Secondary outcome [2] 0 0
Examine pain/discomfort of injections using the different techniques and the different injection sites.
Timepoint [2] 0 0
Immediately following the injection

Eligibility
Key inclusion criteria
1. The subject/parent will give signed Informed Consent before any trial related activities. If the parents sign, it will be secured verbally or in older children in writing that they fully agree to participate.
2. Type 1 children aged = 6 and < 19 years. Puberty will be determined by a trained paediatric endocrinologist using standard Tanner Staging.
3. Type 1 and 2 diabetic adults aged > 19 years and = 85 years.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Skin disease at abdomen and/or thigh.
2. Lipohypertrophy at the site of injection.
3. Any musculoskeletal abnormalities.
4. Psychiatric disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Liggins Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novo Nordisk A/S
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul L Hofman, MD
Address 0 0
Liggins Institute, University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00894270