None listed
Conditions
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.
Interventions
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
Sponsors
Medlab Clinical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Outcome results
None listed