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.

Withdrawn

• Conditions: Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616001072404
• Lead Sponsor: Medlab Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 12

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Blood pathology: FBE, Urea and electrolytes, LFTs, Blood Glucose and insulin [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. ];Composite outcome; BMI, Waist:Hip ratio and Blood Pressure [Baseline (0) measurements on Day 1 and 7. BP measured my sphygmomanometer, Waist:Hip measurement by measuring tape, BMI by scales. ]

Secondary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire [SF12 general health questionnaire at Baseline (0) Day 1 and Day 7. ]