ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Composite Blood pathology: FBE, Urea and electrolytes, LFTs, Blood Glucose and insulin

Timepoint [1]

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]

Composite outcome; BMI, Waist:Hip ratio and Blood Pressure

Timepoint [2]

Baseline (0) measurements on Day 1 and 7. BP measured my sphygmomanometer, Waist:Hip measurement by measuring tape, BMI by scales.

Secondary outcome [1]

Quality of Life Questionnaire

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Medlab Clinical

Address [1]

66 McCauley Street, Alexandria, New South Wales 2015

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute of Integrative Medicine

Ethics committee address [1]

11-23 Burwood Rd, Hawthorn, Melbourne, Victoria 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2015

Approval date [1]

15/09/2015

Ethics approval number [1]

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

Prof Luis Vitetta

Address

Medlab Clinical. 66 McCauley Street, Alexandria, New South Wales 2015

Country

Australia

Phone

+61 (2) 8188 0311

Fax

luis_vitetta@medlab.co

Contact person for public queries

Name

Tessa Nikov

Address

Medlab Clinical. 66 McCauley Street Alexandria, New South Wales 2015

Country

Australia

Phone

+61 (2) 8188 0311

Fax

tessa_nikov@medlab.co

Contact person for scientific queries

Name

Luis Vitetta

Address

Medlab Clinical. 66 McCauley Street, Alexandria, New South Wales 2015

Country

Australia

Phone

+61 (2) 8188 0311

Fax

luis_vitetta@medlab.co

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

Source	Title	Year of Publication	DOI
Dimensions AI	Non-invasive delivery strategies for biologics	2018	https://doi.org/10.1038/nrd.2018.183

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically