Long-term safety of intranasal insulin in insulin-dependent T2 diabetes
Author: Torré Anderson, II, fourth year PhD candidate, Florida A&M University College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health
Researchers are evaluating the safety of intranasal insulin as a treatment for cognitive impairment associated with type 2 diabetes in aging adult populations.
Type 2 diabetes mellitus is a risk factor for neurological and cardiovascular complications linked to accelerated aging of the brain, dementia and stroke. People 65 years of age or older are more affected than any other age group in the world. This aging population has a higher incidence of cognitive dysfunction, impaired executive function, poor self-management and higher risk of falls. The main cause of cognitive impairment is insulin resistance in the brain. Recently, intranasal insulin has become a potentially beneficial treatment for cognitive impairment. Intranasal insulin penetrates the blood-brain barrier and reaches insulin receptors in the brain to improve neuronal activity. Studies suggest that intranasal insulin can improve functional connectivity, circulation flow and vascular tone according to Zhang H et al. 2015.
The aim of the study was to demonstrate the short- and long-term safety of the use of intranasal insulin in participants with type 2 diabetes in the MemAID trial. The researchers conducted the sub-study analysis as a double-blind, randomized controlled trial with a population of 86 selected participants. The subjects were randomized into two treatment arms. The treatment arms included the intranasal insulin arm and the placebo arms with various adjunctive diabetes treatments. Participants were asked to self-monitor their blood sugar levels and record their medication intake, meals and activities. The researchers excluded participants if they had a history of insulin use, allergy to insulin, type 1 diabetes, or severe hypoglycemia. Other exclusion criteria included a history of dementia, liver failure or transplantation, renal failure or transplantation, an MMSE score fasting blood sugar, insulin, and HbA1c, during screening, treatment, and post-treatment.
After the researchers applied the exclusion criteria, 9 participants started treatment with five subjects in the intranasal insulin arm and four subjects in the placebo arm. A total of five subjects completed treatment and follow-up. The researchers observed that the use of intranasal insulin did not affect the blood sugar profile or cause hypoglycemia for two hours. Long-term safety has shown a decrease in the levels of HbA1c, plasma insulin and fasting blood glucose between the start and the post-treatment. Subjects tolerated intranasal insulin without serious adverse events. Two hypoglycemic events occurred in the intranasal insulin group and seven in the placebo group. Two asymptomatic level 2 hypoglycemia events occurred in the intranasal insulin and placebo groups.
The researchers found that observations of intranasal insulin therapy were safe and free of adverse events in aging participants with insulin-dependent type 2 diabetes mellitus. There was no change in the glycemic profile. Lower HbA1c and insulin levels suggest the need for further studies of intranasal insulin therapy. Both short-term and long-term safety data have provided data for future more in-depth studies evaluating the safety of the simultaneous use of intranasal insulin and subcutaneous insulin.
Practice the beads:
- Subjects tolerated intranasal insulin without adverse effects.
- Long-term safety results of intranasal insulin have shown lower levels of HbA1c, plasma insulin and fasting glucose.
- Further study is needed on the concomitant use of intranasal insulin and subcutaneous insulin.
Becerra, LA et al. (2021, June). Long-term safety of intranasal insulin in insulin-dependent type 2 diabetes: a substudy on the safety of memory advancement by intranasal insulin in type 2 diabetes (MemAID). American Diabetes Association. (Requires connection to ADA Symposium.)
B Galindo-Mendez et al. Advancement of Intranasal Insulin Memory in Type 2 Diabetes (MemAID) Randomized Controlled Clinical Trial: Design, Methods, and Rationale. January 2020. https://pubmed.ncbi.nlm.nih.gov/31923471/
Torré Anderson, II, fourth year PhD candidate, Florida A&M University College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health