Out-Of-Hospital Cardiac ArrestPhase 1NCT05062785
Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants
A Phase 1 study testing Intranasal insulin in people with Out-Of-Hospital Cardiac Arrest and Healthy, run by Robert Silbergleit at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Healthy
- What is being tested?
- Intranasal insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 25 Apr 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open Label Dose-Finding Study of Intranasal 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.
Read the detailed description
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.
- Conditions
- Out-Of-Hospital Cardiac Arrest, Healthy
- Being tested
- Intranasal insulin
- Keywords
- Healthy participants, intranasal insulin
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal insulinDrug
Also called HUMULIN R U-500
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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal insulin | Experimental | A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Receives: Drug: Intranasal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Hypoglycemia
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).
Measured: Within 4 hours of dosing during each of 5 visits
Secondary outcomes (30)
Change in Blood Glucose - Study Visit 1 (100 Units)
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.
Measured: Baseline and up to 4 hours after drug administration (Study Visit 1, Day 1)
Change in Blood Glucose - Study Visit 1 (200 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 1 (400 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 2 (400 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 2 (600 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 3 (600 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 3 (800 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 4 (800 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 4 (900 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 5 (1000 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 1 (100 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 1 (200 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 1 (400 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 2 (400 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 2 (600 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 3 (600 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 3 (800 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 4 (800 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 4 (900 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 5 (1000 Units)
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.
Measured: Baseline, up to 4 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start4 Oct 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- For every 6 participants, iterations of a Bayesian model will be performed to associate the administered dose with the frequency of dose-limiting hypoglycemia or other adverse events. The model will adaptively reallocate the dose increments for the next 6 participants. To provide more precise and reproducible estimates of dose-limiting toxicity, the trial will modify the size of dose increments based on the developing model to allocate more administrations to areas of the model with greatest uncertainty, or to higher doses in the absence of dose-limiting hypoglycemia.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Silbergleit
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Robert Silbergleit, University of Michigan
- Investigators
- Robert Silbergleit, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062785
- Sponsor's protocol ID
- HUM00171279
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open Label Dose-Finding Study of Intranasal Insulin in Healthy Participants
- ClinicalTrials.gov ID
- NCT05062785
- Acronym / sponsor ID
- HUM00171279
- Conditions
- Out-Of-Hospital Cardiac Arrest, Healthy
- Keywords
- Healthy participants, intranasal insulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Robert SilbergleitUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For every 6 participants, iterations of a Bayesian model will be performed to associate the administered dose with the frequency of dose-limiting hypoglycemia or other adverse events. The model will adaptively reallocate the dose increments for the next 6 participants. To provide more precise and reproducible estimates of dose-limiting toxicity, the trial will modify the size of dose increments based on the developing model to allocate more administrations to areas of the model with greatest uncertainty, or to higher doses in the absence of dose-limiting hypoglycemia.
| Arm | Type | Receives |
|---|---|---|
| Intranasal insulin | Experimental | Drug: Intranasal insulinA total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal insulinAlso: HUMULIN R U-500This 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. | Drug | Intranasal insulin |
Primary outcome
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).
30 secondary outcomes
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 Blood Glucose - Study Visit 1 (200 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 1 (400 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 2 (400 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 2 (600 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 3 (600 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 3 (800 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 4 (800 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 4 (900 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Blood Glucose - Study Visit 5 (1000 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 1 (100 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 1 (200 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 1 (400 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 2 (400 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 2 (600 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 3 (600 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 3 (800 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 4 (800 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 4 (900 Units)
Time frame: Baseline, up to 4 hours after drug administration
Change in Serum Insulin - Study Visit 5 (1000 Units)
Time frame: Baseline, up to 4 hours after drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to a complete de-identified participant-level dataset archived in the University of Michigan Deep Blue Repository consistent with the Open Science standards of the American Heart SocietyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Silbergleit, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal insulin in people with Out-Of-Hospital Cardiac Arrest and Healthy, run by Robert Silbergleit at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Hypoglycemia (time frame: Within 4 hours of dosing during each of 5 visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.