18 Participants Needed

Intranasal Insulin for Healthy Adults

(INI-CSF-MA Trial)

BK
ME
Overseen ByMeghan E O'Brien
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: HealthPartners Institute
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug intranasal insulin for healthy adults?

Research shows that intranasal insulin, like Nasulin, can be absorbed effectively through the nasal passage, which suggests it could be a viable way to deliver insulin quickly. Additionally, insulin detemir, a component of the treatment, has been shown to effectively manage blood sugar levels in people with diabetes, indicating its potential effectiveness in other uses.12345

Is intranasal insulin safe for healthy adults?

Intranasal insulin has been studied in healthy volunteers and other groups, showing good safety with no serious side effects reported. Some studies noted mild nasal irritation, but overall, it was well-tolerated.12678

How is intranasal insulin different from other insulin treatments?

Intranasal insulin is unique because it is administered through the nose, allowing for rapid absorption directly into the bloodstream, which can be faster than traditional injections. This method also shows potential benefits for cognitive improvement in conditions like mild cognitive impairment or early-stage Alzheimer's disease.126910

What is the purpose of this trial?

The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with neurological diseases such as mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.18 healthy middle-aged adults will be randomly assigned to receive a single intranasal dose of 40 units insulin ("low dose" group), 80 units insulin ("high dose" group), or saline (placebo, or control group). Participants will undergo an image-guided lumbar puncture (spinal tap) performed by a study clinician. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of insulin to reach the brain after intranasal administration.

Research Team

LR

Leah R Hanson, PhD

Principal Investigator

HealthPartners Institute

KB

Kimberly Byrnes, PhD

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility Criteria

This trial is for healthy middle-aged adults. Participants must be willing to receive a nasal spray and undergo a lumbar puncture (spinal tap) to collect cerebrospinal fluid samples.

Inclusion Criteria

MOCA score ≥26
Subject must be proficient in speaking English to comply with instructions and measures for the study
Subject can provide written informed consent
See 3 more

Exclusion Criteria

Subject is pregnant or breast feeding
Subject has participated in a clinical trial investigation within 3 months of this study
I require insulin for my diabetes.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single intranasal dose of insulin or saline, followed by lumbar puncture and sample collection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

  • Intranasal Insulin
Trial Overview The study tests if insulin can reach the brain when given as a nasal spray. It compares the effects of two different doses of insulin with saline in 18 participants, who will have their cerebrospinal fluid and blood tested at several time points after dosing.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low dose intranasal insulinExperimental Treatment1 Intervention
One dose of 40 international units of regular insulin administered intranasally.
Group II: High dose Intranasal InsulinExperimental Treatment1 Intervention
One dose of 80 international units of regular insulin administered intranasally.
Group III: Placebo ControlPlacebo Group1 Intervention
One dose of 0.9% saline administered intranasally.

Intranasal Insulin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Intranasal insulin for:
  • Diabetes
🇪🇺
Approved in European Union as Intranasal insulin for:
  • Diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials
196
Recruited
3,721,000+

Uniformed Services University of the Health Sciences

Collaborator

Trials
130
Recruited
91,100+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Findings from Research

The intranasal insulin formulation (Nasulin) was well tolerated in a study of 13 healthy male volunteers, showing a significant rise in serum insulin and a decrease in plasma glucose after administration.
Nasulin demonstrated a peak insulin absorption time of 10-20 minutes, with a relative absorption of 12.0% from the dominant nostril and 15.4% from the nondominant nostril, indicating it can be effectively administered regardless of nasal cycle.
Pharmacokinetics and pharmacodynamics of intranasal insulin spray (Nasulin) administered to healthy male volunteers: infuence of the nasal cycle.Leary, AC., Dowling, M., Cussen, K., et al.[2021]
The study demonstrated that administering intranasal insulin in a single nostril significantly enhances absorption, achieving higher maximum concentrations (C(max)) compared to dual nostril administration, with maximum levels reaching 96 µU/ml for a 75 U dose.
The enhanced absorption was attributed to the increased amount of insulin administered rather than the absorption enhancer CPE-215, indicating that higher doses of insulin can improve its effectiveness when delivered intranasally.
Enhanced absorption of Nasulin™, an ultrarapid-acting intranasal insulin formulation, using single nostril administration in normal subjects.Stote, R., Miller, M., Marbury, T., et al.[2021]
In a study involving 112 children and adolescents with type 1 diabetes, the combination of ultrashort acting insulin aspart with detemir or glargine showed a significant decrease in HbA1c levels, indicating improved blood sugar control over 12 and 24 weeks.
The use of detemir and glargine significantly reduced the risk of hypoglycemia compared to traditional NPH-insulin, while maintaining a stable body mass index in the detemir group, suggesting a safer and more effective treatment option.
[Basal insulin analogue versus traditional NPH insulin in basal bolus therapy of children and adolescents with type 1 diabetes].Prikhodina, OA., Surikova, SV., Girsh, YV.[2020]

References

Pharmacokinetics and pharmacodynamics of intranasal insulin spray (Nasulin) administered to healthy male volunteers: infuence of the nasal cycle. [2021]
Enhanced absorption of Nasulin™, an ultrarapid-acting intranasal insulin formulation, using single nostril administration in normal subjects. [2021]
3.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Basal insulin analogue versus traditional NPH insulin in basal bolus therapy of children and adolescents with type 1 diabetes]. [2020]
Insulin detemir is characterized by a consistent pharmacokinetic profile across age-groups in children, adolescents, and adults with type 1 diabetes. [2019]
Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. [2022]
Long-acting intranasal insulin detemir improves cognition for adults with mild cognitive impairment or early-stage Alzheimer's disease dementia. [2022]
Effects of Regular and Long-Acting Insulin on Cognition and Alzheimer's Disease Biomarkers: A Pilot Clinical Trial. [2022]
Intranasal insulin: the effects of three dose regimens on postprandial glycaemic profiles in type II diabetic subjects. [2019]
Nasal absorption of mixtures of fast-acting and long-acting insulins. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Intranasal insulin: from nose to brain. [2011]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security