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NCT Number: NCT05062785

Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants

This study is to determine the safety and tolerability of regular insulin (Humulin R) when given intranasally (as drops in nostrils).

Healthy participants will be enrolled to determine the maximum tolerated dose of intranasal insulin.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Healthy Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

This is being studied because intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest. Cardiac arrest is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin, given immediately after a cardiac arrest may prevent or reduce brain injury. Nasal insulin reduces brain injury in animal experiments, and has been used to try to improve brain degeneration in patients with Alzheimer's disease. However, cardiac arrest patients may need higher doses than patients with Alzheimer's disease, therefore, this study is to examine those higher doses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good health based on medical history, physical exam, and routine laboratory testing.
  • Female participants must have negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 years with the absence of menses for greater than 12 months. Tubal ligation with menses within the past 12 months is not considered to be surgical sterilization.
  • Body mass index (BMI) between 18 kilogram / square meter (kg/m2) and 35 kg/m2.
  • Willing and able to stay at the clinical research facility as required by the protocol
  • Willing and able to comply with the investigational nature of the study and able to communicate well with investigators
  • Ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines

Exclusion criteria

  • Known allergy to insulin.
  • Preexisting diabetes.
  • Current or previous use of diabetes medication or insulin.
  • Any nasal disease or congestion that may interfere with intranasal drug absorption.
  • Baseline hypoglycemia (blood glucose ≤ 65 mg/dL) or hyperglycemia (blood glucose > 200 mg/dL) as evident from the screening labs.
  • Active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness
  • Blood donation in excess of 500 milliliter (mL) within 60 days prior to the first dose of study medication.
  • Treated with an investigational drug within 30 days.
  • Individuals with inadequate venous access.

Treatment and study plan

Intranasal insulin

Drug

This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.

On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a a 4 hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.

Other names: HUMULIN R U-500

Primary outcomes

  1. Severe Hypoglycemia

    Time frame: Within 4 hours of dosing during each of 5 visits

    Results reflect the participants who experienced severe hypoglycemia generically at the time they received a dose of insulin, as defined by blood glucose < 45 milligrams per deciliter (mg/dL). Severe hypoglycemia was considered a dose limiting toxicity (DLT).

Secondary outcomes

  1. Change in Blood Glucose - Study Visit 1 (100 Units)

    Time frame: Baseline and up to 4 hours after drug administration (Study Visit 1, Day 1)

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  2. Change in Blood Glucose - Study Visit 1 (200 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  3. Change in Blood Glucose - Study Visit 1 (400 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  4. Change in Blood Glucose - Study Visit 2 (400 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  5. Change in Blood Glucose - Study Visit 2 (600 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  6. Change in Blood Glucose - Study Visit 3 (600 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  7. Change in Blood Glucose - Study Visit 3 (800 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  8. Change in Blood Glucose - Study Visit 4 (800 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  9. Change in Blood Glucose - Study Visit 4 (900 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  10. Change in Blood Glucose - Study Visit 5 (1000 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.

  11. Change in Serum C-peptide Levels - Study Visit 1 (100 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study visit. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  12. Change in Serum C-peptide Levels - Study Visit 1 (200 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study visit. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  13. Change in Serum C-peptide Levels - Study Visit 1 (400 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study visit. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  14. Change in Serum C-peptide Levels - Study Visit 2 (400 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  15. Change in Serum C-peptide Levels - Study Visit 2 (600 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  16. Change in Serum C-peptide Levels - Study Visit 3 (600 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  17. Change in Serum C-peptide Levels - Study Visit 3 (800 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  18. Change in Serum C-peptide Levels - Study Visit 4 (800 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  19. Change in Serum C-peptide Levels - Study Visit 4 (900 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  20. Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.

  21. Change in Serum Insulin - Study Visit 1 (100 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  22. Change in Serum Insulin - Study Visit 1 (200 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  23. Change in Serum Insulin - Study Visit 1 (400 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  24. Change in Serum Insulin - Study Visit 2 (400 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  25. Change in Serum Insulin - Study Visit 2 (600 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  26. Change in Serum Insulin - Study Visit 3 (600 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  27. Change in Serum Insulin - Study Visit 3 (800 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  28. Change in Serum Insulin - Study Visit 4 (800 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  29. Change in Serum Insulin - Study Visit 4 (900 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

  30. Change in Serum Insulin - Study Visit 5 (1000 Units)

    Time frame: Baseline, up to 4 hours after drug administration

    Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.

Sponsors and collaborators

Lead sponsor

Robert Silbergleit

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Phase 1, Open Label Dose-Finding Study of Intranasal Insulin in Healthy Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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