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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
University of Michigan
Ann Arbor, Michigan, United States
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).
Time frame: Within 4 hours of dosing during each of 5 visits
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.
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)
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, up to 4 hours after drug administration