Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001072404
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
10/08/2016
Date last updated
21/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 0 Open-labelled Clinical Trial To Investigate The Safety of a Micro-dose of a Nanocelle'Trademark' Insulin Formulation Administered Oro-buccally in Healthy Adult Volunteers.
Scientific title
A Phase 0 Open-labelled Clinical Trial To Investigate The Safety of a Micro-dose of a Nanocelle'Trademark' Insulin Formulation Administered Oro-buccally in Healthy Adult Volunteers.
Secondary ID [1] 289859 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 299800 0
Condition category
Condition code
Metabolic and Endocrine 299728 299728 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To evaluate the safety of a nanocelle insulin (short acting) formulation as an administered oro-buccal spray in a (particle size of 0.05–0.2 microns) at a concentration of 0.01 Unit / 150 microlitre / spray / day for 7 days. One spray per day for 7 days. Note: 1 Unit of insulin will reduce blood glucose by 2.8 mmol/L
Intervention code [1] 295542 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299215 0
Composite Blood pathology: FBE, Urea and electrolytes, LFTs, Blood Glucose and insulin
Timepoint [1] 299215 0
Blood samples post dose administration on Days 1 and 7 at Baseline (0), 15, 30, 60 and 90 minutes (via cannulation). On Days 1 to 7, Blood Glucose measurement at 15, 30, 60 and 90 minutes via cannulation post dose.
Primary outcome [2] 299216 0
Composite outcome; BMI, Waist:Hip ratio and Blood Pressure
Timepoint [2] 299216 0
Baseline (0) measurements on Day 1 and 7. BP measured my sphygmomanometer, Waist:Hip measurement by measuring tape, BMI by scales.
Secondary outcome [1] 326537 0
Quality of Life Questionnaire
Timepoint [1] 326537 0
SF12 general health questionnaire at Baseline (0) Day 1 and Day 7.

Eligibility
Key inclusion criteria
1) 6 Females and 6 Males
2) Participants > 18 years of age of entry on study
3) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
4) Participants agree to undergo venipuncture on multiple occasions
5) Participants agree to adhere to the study protocol
6) Have not been prescribed or have had administered insulin or any other glucose lowering compound
7) No history of any chronic diseases
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs
2) Diagnosis of Type 2 diabetes mellitus (administered insulin)
3) Diagnosis of Type 1 diabetes mellitus
4) Alcohol abuse
5) Pregnant or nursing an infant
6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant
7) The current use of any dietary and herbal supplements
8) The use of illicit drugs

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294256 0
Commercial sector/Industry
Name [1] 294256 0
Medlab Clinical
Country [1] 294256 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, New South Wales 2015
Country
Australia
Secondary sponsor category [1] 293088 0
None
Name [1] 293088 0
Address [1] 293088 0
Country [1] 293088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295683 0
National Institute of Integrative Medicine
Ethics committee address [1] 295683 0
11-23 Burwood Rd, Hawthorn, Melbourne, Victoria 3122
Ethics committee country [1] 295683 0
Australia
Date submitted for ethics approval [1] 295683 0
01/09/2015
Approval date [1] 295683 0
15/09/2015
Ethics approval number [1] 295683 0
0027E_2015

Summary
Brief summary
Diabetes is a chronic disorder that affects over 346 million people worldwide. The estimated cost is more than $174 billion to the US. There are three categories, Type 1, Type 2 and gestational diabetes. Type 1 diabetes is an auto-immune condition in which the immune system is activated to destroy the cells in the pancreas which produce insulin. People with type 1 diabetes depend on synthetic insulin every day of their lives to replace the insulin the body cannot produce. Without insulin, the body burns its own fats as a substitute which releases chemical substances in the blood. Good glycaemic control reduces the risk for retinal, renal, and neuropathic complications in patients with type 1 diabetes mellitus. The conventional therapy for T1 and some T2 patients is a daily injections regimen. A mixture of rapid-acting and basal insulin is mixed to mimic the gold standard therapy. Elderly patients who use insulin are more at risk of hypoglycaemia because of a high prevalence of cognitive impairment and the patients’ potential ability to administer and monitor insulin therapy. The current challenge is how to get Type 1 patients to take insulin conveniently and non-invasive. Alternative oral delivery platforms have been attempted since 1925 but the hurdle is to move a large molecule like insulin across mucosal membranes. The dosage also was impractical and non-therapeutic. In addition, many patients view insulin therapy as confronting and uncomfortable, with side effects such as hypoglycaemia and weight gain. Previous studies on micellised formulations such as Oralgen, have compared the kinetics of different doses of Oralgen to standard subcutaneous regular human insulin injections. In both studies, Oralgen was associated with a higher maximum concentration [Cmax] and shorter time to reach the maximum peak [Tmax]. Medlab has developed a new platform for insulin delivery. The aim of the project is to mimic the pharmacokinetic data of naturally produced body insulin or the injectable insulin. The new platform will hope to achieve a better compliance rate with a less invasive delivery method. The aim of the project is to achieve a better Cmax and shorter Tmax.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68046 0
Prof Luis Vitetta
Address 68046 0
Medlab Clinical. 66 McCauley Street, Alexandria, New South Wales 2015
Country 68046 0
Australia
Phone 68046 0
+61 (2) 8188 0311
Fax 68046 0
Email 68046 0
[email protected]
Contact person for public queries
Name 68047 0
Miss Tessa Nikov
Address 68047 0
Medlab Clinical. 66 McCauley Street Alexandria, New South Wales 2015
Country 68047 0
Australia
Phone 68047 0
+61 (2) 8188 0311
Fax 68047 0
Email 68047 0
[email protected]
Contact person for scientific queries
Name 68048 0
Prof Luis Vitetta
Address 68048 0
Medlab Clinical. 66 McCauley Street, Alexandria, New South Wales 2015
Country 68048 0
Australia
Phone 68048 0
+61 (2) 8188 0311
Fax 68048 0
Email 68048 0
[email protected]

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

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AINon-invasive delivery strategies for biologics2018https://doi.org/10.1038/nrd.2018.183
N.B. These documents automatically identified may not have been verified by the study sponsor.