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Trial registered on ANZCTR


Registration number
ACTRN12612000711819
Ethics application status
Approved
Date submitted
3/07/2012
Date registered
3/07/2012
Date last updated
31/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
InsuJet 1: A randomised, open label study to evaluate the efficacy, safety and tolerability of insulin aspart administered by InsuJet device or by subcutaneous injection in people with type 1 diabetes mellitus.
Scientific title
InsuJet 1: A phase II randomised, open label, cross-over design, pilot study to evaluate the efficacy, safety and tolerability of insulin aspart administered by InsuJet device or by subcutaneous injection and measure effects on post meal glucose excursion in people with type 1 diabetes mellitus.
Secondary ID [1] 280762 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 286813 0
Condition category
Condition code
Metabolic and Endocrine 287097 287097 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The device InsuJetTM is intended for the subcutaneous injection of insulin, without the use of needles. The study is designed to compare the effect of immediate pre prandial administration by InsuJet device versus subcutaneous injection on the pharmacokinetics and metabolic effects of rapid-acting human insulin analogue aspart in people with Type 1 Diabetes Mellitus following a liquid meal tolerance test. This trial is a cross over design study involving a screening visit and two site visits. The time period between the two site visits is one week. At the site visits the participant blood samples will be taken at t=-10 mins and t=0 mins. Immediately after the t=0 mins blood sample, an injection of Insulin aspart will be administered using the InsuJet device or Insulin pen based on the allocation of treatment by randomisation technique. Patient should have known insulin to carbohydrate ratio for calculating the bolus dose of rapid acting insulin analogue. Then the participant will drink the standardised liquid meal (Each can contains1120kJ, 9.3g protein, 43g carbohydrate and 6.5g fat). Further blood samples will be taken at +15, +30, +45, 60, +90, +120, +150, +180 and +240 mins. Venous samples will be taken for plasma glucose and serum insulin levels. For purposes of safety, capillary blood glucose monitoring by glucometer will be done at +30, +60, +120, +180 and +240 mins. The test will take place in a controlled laboratory environment under the supervision of trained clinical research staff. Processing will be done on site and assays will be assessed at the local laboratory after appropriate storage. The study has two arms.
1. Insulin aspart administered by InsuJet device.
2. Insulin aspart administered by Insulin pen.
Intervention code [1] 285187 0
Treatment: Devices
Comparator / control treatment
Standard care : Insulin aspart is administered by subcutaneous injection using Insulin pen.
Control group
Active

Outcomes
Primary outcome [1] 287443 0
Mean change in glucose concentration (Glu exc) defined as (Cmax glu - baseline glu) where Cmax glu = maximal post prandial plasma glucose level (from t = +15 mins to t =+ 240 mins) and baseline glu = mean of plasma glucose concentration at t = - 10 mins and t = 0 mins.
Timepoint [1] 287443 0
Timepoint: 4 hrs after the start of the meal test.
Secondary outcome [1] 298158 0
Area under the glucose concentration-time curve (AUC)glu (0-240) defined as AUC from t = 0 mins to t = +240 mins calculated by the trapezoid rule.
Timepoint [1] 298158 0
Timepoint: 4 hrs after the start of the meal test.
Secondary outcome [2] 298159 0
Patient device preference, assessed by end of study questionnaire by the name "InsuJet study questionnaire"
Timepoint [2] 298159 0
Timepoint: End of the study
Secondary outcome [3] 298160 0
Relative injection pain, assessed by visual analogue scale (VAS)
Timepoint [3] 298160 0
Timepoint: At end of each meal tolerance test.

Eligibility
Key inclusion criteria
1. Patient has given informed consent obtained before any trial-related activities.
2. Type 1 diabetes defined as patient on insulin treatment within one year of diagnosis.
3.Insulin treatment: on any insulin regimen for more than one year and on stable insulin basal-bolus regimen (defined as total daily dose of insulin not varying by > 20% from usual total daily dose) for greater than or equal to 3 months at the time of inclusion. Patient should have known insulin to carbohydrate ratio for calculating the bolus dose of rapid acting insulin analogue.
4. HbA1c less than or equal to 10%.
5. Age between 18 and 65 years.
6. BMI between 18 and 40 kg/m2
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known or suspected allergy to any of the trial products, including the food product used for the meal tolerance test.
2. History of major hypoglycaemic episodes, defined as hypoglycaemic events requiring external assistance within the last year.
3. Unstable angina, myocardial infarction or heart failure (NYHA class III-IV)less than or equal to 3 months of inclusion.
4. Seated BP more than or equal to 180/100 mmHg.
5. Impaired hepatic function (ALT alanine transaminase > 2.5 x upper reference limit of the local laboratory.)
6. Impaired renal function (eGFR MDRD < 30 ml/min/1.73m2).
7. Pregnancy at time of inclusion.
8. Mental incapacity, unwillingness, language barrier or other factor that in the investigator’s opinion precludes adequate understanding of the trial procedure or cooperation with trial site personnel.
9.Abuse of alcohol or narcotics
10. Known or suspected gastro paresis, or previous gastric surgical procedure that may interfere with gastric emptying (e.g. gastric laparoscopic banding, gastric stapling and partial gastrectomy).
11. Regular use of gastric prokinetic agents or other agents known to affect the motility of the stomach, such as anticholinergic agents (topical eye drops are allowed) or tricyclic antidepressants within 2 days of inclusion.
12. Glucocorticoid use within 7 days of inclusion (excluding inhaled or topical steroid).
13.Receipt of any investigational product within 30 days prior to inclusion in this trial

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285550 0
Commercial sector/Industry
Name [1] 285550 0
Pharmaco Australia Ltd
Address [1] 285550 0
Locked Bag 1009
Gordon
NSW 2072
Country [1] 285550 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne, Victoria 3004
(Postal address: PO Box 6492, St Kilda Road Central, Victoria 8008)
Country
Australia
Secondary sponsor category [1] 284390 0
None
Name [1] 284390 0
Address [1] 284390 0
Country [1] 284390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287564 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 287564 0
The Alfred Hospital,
55 Commercial Road,
Melbourne,
Victoria 3004
Ethics committee country [1] 287564 0
Australia
Date submitted for ethics approval [1] 287564 0
28/05/2012
Approval date [1] 287564 0
30/07/2012
Ethics approval number [1] 287564 0
1/12/0236

Summary
Brief summary
Type 1 diabetes is a condition treated with lifelong insulin injections and requires multiple daily injections. These injections are usually well tolerated but cause discomfort in some patients. A new jet injector device for painless injections of insulin without needles has been developed. This has been trialled in subjects without diabetes and shown to be an effective way of delivering insulin. Initial studies also show that the insulin appears to be absorbed more rapidly using this device compared with the usual subcutaneous injections. This is of potential benefit to patients with Type 1 Diabetes who often find that blood glucose levels rise too rapidly after meals using conventional subcutaneous injections of insulin. This study is designed test the safety and efficacy of the InsuJet device in patients with type 1 diabetes, and to measure the rise in blood glucose levels after a meal using Insujet to administer the insulin as compared with standard subcutaneous injections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34365 0
Address 34365 0
Country 34365 0
Phone 34365 0
Fax 34365 0
Email 34365 0
Contact person for public queries
Name 17612 0
Associate Professor Neale Cohen
Address 17612 0
Baker IDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd
Melbourne, VIC, 3004
Country 17612 0
Australia
Phone 17612 0
61 3 8532 1800
Fax 17612 0
61 3 8532 1899
Email 17612 0
neale.cohen@bakeridi.edu.au
Contact person for scientific queries
Name 8540 0
Associate Professor Neale Cohen
Address 8540 0
Baker IDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd
Melbourne, VIC, 3004
Country 8540 0
Australia
Phone 8540 0
61 3 8532 1800
Fax 8540 0
61 3 8532 1899
Email 8540 0
neale.cohen@bakeridi.edu.au

No information has been provided regarding IPD availability
Summary results
No Results