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Trial registered on ANZCTR


Registration number
ACTRN12620000253909
Ethics application status
Approved
Date submitted
16/02/2020
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A study examining the injection of insulin into layers of the skin (compared to conventional injection under the skin) by an injector device named Med-Jet H4
Scientific title
A Pilot Study Examining the Feasibility of Intradermal Insulin Injection by an Injector Device (Med-Jet H4) in Healthy Adults.
Secondary ID [1] 300565 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 316297 0
Condition category
Condition code
Metabolic and Endocrine 314566 314566 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention involves a single intradermal injection with Med-Jet H4 device of 10 units of insulin aspart (Novorapid; Novo Nordisk) in healthy non-diabetic individuals.
Med-Jet H4 (Medical International Technologies Canada, Montreal, Quebec, Canada) is a needle-free injector device which can inject the drugs intradermally..
Injection will be performed by a trained nurse and is a one-off injection.

This is a cross-over study with a 2-week wash-out period between treatments.
Intervention code [1] 316872 0
Treatment: Devices
Comparator / control treatment
Control arm involves a single subcutaneous injection with FlexPen® of 10 units of insulin aspart (Novorapid; Novo Nordisk) in healthy non-diabetic individuals.
NovoRapid FlexPen is a pre-filled insulin pen (colour-coded) contains 300 units of insulin aspart (Novorapid) designed to be used with disposable needles to deliver insulin subcutaneously. FlexPen can be dialled to the desired unit to deliver the desired insulin dose.
Injection will be performed by a trained nurse and is a one-off injection.
Control group
Active

Outcomes
Primary outcome [1] 322892 0
Median time to maximum plasma insulin concentration (Tmax) when insulin aspart delivered by intradermal injection with Med-Jet H4 device versus subcutaneous injection.
Timepoint [1] 322892 0
Day 1 and Day 14
This isa randomised crossover study.
On day 1, participants will be injected insulin aspart (depending on randomisation), either intradermally by Med-Jet H4 or subcutaneously and the primary outcome will be measured.
On day 14, participants will be crossed over to the opposite study arm, and primary outcome will be measured
Primary outcome [2] 322894 0
Median maximum plasma insulin concentration (Cmax) when insulin aspart delivered by intradermal injection with Med-Jet H4 device versus subcutaneous injection.
Timepoint [2] 322894 0
Day 1 and Day 14
Secondary outcome [1] 380162 0
Glucose Area under the curve (AUC) 1 hour after insulin administration (Glucose AUC 0-1h) assessed based on plasma glucose level measured at different points during the study.

Note: Venous blood samples will be collected for plasma glucose and insulin measurements (by the relevant assay) at 0 minute (just before injection of insulin) and +15, +30, +45, +60, +75, +90, +105, +120, +150, +180, +210, +240 minutes post insulin injection.
Timepoint [1] 380162 0
1 hour after insulin administration on day 1 and day 14
Secondary outcome [2] 380163 0
Glucose AUC 2 hours after insulin administration (Glucose AUC 0-2h) assessed based on plasma glucose level measured at different points during the study.
Timepoint [2] 380163 0
2 hour after insulin administration on day 1 and day 14
Secondary outcome [3] 380164 0
Glucose AUC 2-4 hours after insulin administration (Glucose AUC 2-4h) assessed based on plasma glucose level measured at different points during the study.
Timepoint [3] 380164 0
4 hour after insulin administration on day 1 and day 14
Secondary outcome [4] 380165 0
Glucose AUC 4-6 hours after insulin administration (Glucose AUC 4-6h) assessed based on plasma glucose level measured at different points during the study.
Timepoint [4] 380165 0
6 hour after insulin administration on day 1 and day 14
Secondary outcome [5] 380166 0
Insulin AUC 1 hour after insulin administration (Insulin AUC 0-1h) assessed based on plasma insulin level measured at different points during the study.
Timepoint [5] 380166 0
1 hour after insulin administration on day 1 and day 14
Secondary outcome [6] 380167 0
Insulin AUC 2 hours after insulin administration (Insulin AUC 0-2h) assessed based on plasma insulin level measured at different points during the study.
Timepoint [6] 380167 0
2 hour after insulin administration on day 1 and day 14
Secondary outcome [7] 380168 0
Insulin AUC 2-4 hours after insulin administration (Insulin AUC 2-4h) assessed based on plasma insulin level measured at different points during the study.
Timepoint [7] 380168 0
4 hour after insulin administration on day 1 and day 14
Secondary outcome [8] 380169 0
Insulin AUC 4-6 hours after insulin administration (Insulin AUC 4-6h) assessed based on plasma insulin level measured at different points during the study.
Timepoint [8] 380169 0
6 hour after insulin administration on day 1 and day 14
Secondary outcome [9] 380170 0
Adverse events post insulin injections (Hypoglycaemia, Skin reaction at the injection sites) assessed by direct clinical observation post insulin injection.
Timepoint [9] 380170 0
Day 1 and Day 14
Secondary outcome [10] 380171 0
Relative injection pain, assessed by visual analogue scale (VAS)
Timepoint [10] 380171 0
Day 1 and Day 14
Secondary outcome [11] 380172 0
Patient device preference ( Med-Jet H4 device versus FlexPen®) assessed by end of study questionnaire. The questionnaire will be designed specifically for this study.
Timepoint [11] 380172 0
Day 1 and Day 14

Eligibility
Key inclusion criteria
- Healthy non-diabetic adult volunteers
- BMI: 18-27 kg/m2
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Diabetes or pre-diabetes as confirmed by HbA1C > 5.6%
- Dermatological conditions at the injection sites that may interfere with insulin absorption
- Pregnancy
- Glucocorticoid use within 7 days of inclusion (excluding inhaled or topical steroid)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed by a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
7/09/2020
Actual
Date of last data collection
Anticipated
21/09/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15893 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 29350 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 304983 0
Other
Name [1] 304983 0
Baker Heart and Diabetes Institute - Melbourne
Country [1] 304983 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute - Melbourne
Address
75 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 305344 0
None
Name [1] 305344 0
Address [1] 305344 0
Country [1] 305344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305386 0
Bellberry Limited
Ethics committee address [1] 305386 0
Ethics committee country [1] 305386 0
Australia
Date submitted for ethics approval [1] 305386 0
Approval date [1] 305386 0
31/01/2020
Ethics approval number [1] 305386 0
HREC2018-08-692

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

Contacts
Principal investigator
Name 100202 0
A/Prof Neale Cohen
Address 100202 0
Baker Heart and Diabetes Institute, 99 Commercial Road, Melbourne, VIC, 3004
Country 100202 0
Australia
Phone 100202 0
+61385321800
Fax 100202 0
Email 100202 0
neale.cohen@baker.edu.au
Contact person for public queries
Name 100203 0
Amin Sharifi
Address 100203 0
Baker Heart and Diabetes Institute Level 4, 99 Commercial Road, Melbourne, VIC, 3004
Country 100203 0
Australia
Phone 100203 0
+61385321800
Fax 100203 0
Email 100203 0
amin.sharifi@baker.edu.au
Contact person for scientific queries
Name 100204 0
Amin Sharifi
Address 100204 0
Baker Heart and Diabetes Institute Level 4, 99 Commercial Road, Melbourne, VIC, 3004
Country 100204 0
Australia
Phone 100204 0
+61385321800
Fax 100204 0
Email 100204 0
amin.sharifi@baker.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.