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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal insulin | Experimental | A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within 4 hours of dosing during each of 5 visits |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and up to 4 hours after drug administration (Study Visit 1, Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Silbergleit, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Label | URL |
|---|---|
| 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 Society | View source |
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The dosing schedule for each cohort was based on the occurrence of SAEs in the previous cohort. If no SAE occurred in any of the cohort's participants, then the dose escalation schedule for the next cohort was weighted towards higher doses and excluded a lower dose. One participant in Cohort 2 did not attend the final visit after Cohort 3 had already begun, so Cohort 3's dosing was not adjusted. Only Cohort 4 adaptively shifted to higher doses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Drug: Intranasal insulin 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 units (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 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. Participants in Cohort 1 were supposed to receive a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| FG001 | Cohort 2 | Drug: Intranasal insulin 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 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. Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| FG002 | Cohort 3 | Drug: Intranasal insulin 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 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. Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| FG003 | Cohort 4 | Drug: Intranasal insulin 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 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. Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Visit 1 |
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| Washout 1 (Up to 10 days) |
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| Study Visit 2 |
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| Washout 2 (Up to 10 days) |
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| Study Visit 3 |
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| Washout 3 (Up to 10 days) |
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| Study Visit 4 |
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| Washout 4 (Up to 10 days) |
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| Study Visit 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Drug: Intranasal insulin 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 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. Participants in Cohort 1 were supposed to receive a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | Within 4 hours of dosing during each of 5 visits |
|
Up to 61 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 100 Units given intranasally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild hypoglycemia [600 units] | Endocrine disorders | Systematic Assessment | Less than or equal to 70 mg/dL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Silbergleit | University of Michigan | 734-936-6284 | robie@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2021 | Jun 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, up to 4 hours after drug administration |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 400 units |
|
| 600 units |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| 600 units |
|
| 800 units |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| 500 units | Participant was moved to 500-unit dose following episode of severe hypoglycemia in Study Visit 3. |
|
| 800 units |
|
| 900 units |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| 500 units | Participant was moved to 500-unit dose following episode of severe hypoglycemia in Study Visit 3. |
|
| 1000 units |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Cohort 2 | Drug: Intranasal insulin 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 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. Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| BG002 | Cohort 3 | Drug: Intranasal insulin 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 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. Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| BG003 | Cohort 4 | Drug: Intranasal insulin 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 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. Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Cohort 2 | Drug: Intranasal insulin 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 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. Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| OG002 | Cohort 3 | Drug: Intranasal insulin 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 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. Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
| OG003 | Cohort 4 | Drug: Intranasal insulin 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 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. Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit. Other Names: HUMULIN R U-500 |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mg per dL | Baseline and up to 4 hours after drug administration (Study Visit 1, Day 1) |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
|
|
|
| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
|
|
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| Secondary | 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. | 1 participant experienced a hypoglycemic episode, and blood was drawn at additional intervals. The additional intervals were neither prespecified outcome measures nor intended to be outcome measures and were collected for safety data only. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
|
|
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant in Cohort 4 withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | mg per dL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant in Cohort 4 withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | ng per mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant experienced a hypoglycemic episode, and blood was drawn at additional intervals. The additional intervals were neither prespecified outcome measures nor intended to be outcome measures and were collected for safety data only. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. 1 participant experienced a hypoglycemic episode, and blood was drawn at additional intervals. The additional intervals were neither prespecified outcome measures nor intended to be outcome measures and were collected for safety data only. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
|
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| Secondary | 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. | 1 participant withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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| Secondary | 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. | 1 participant in Cohort 4 withdrew from the trial prior to Study Visit 2. | Posted | Mean | Standard Deviation | µU/mL | Baseline, up to 4 hours after drug administration |
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|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 200 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 200 Units given intranasally. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | 400 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 400 Units given intranasally. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | 500 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 500 Units given intranasally. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG004 | 600 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 600 Units given intranasally. | 0 | 23 | 0 | 23 | 2 | 23 |
| EG005 | 800 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 800 Units given intranasally. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG006 | 900 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 900 Units given intranasally. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG007 | 1000 Units | Drug: Intranasal insulin (Other Names: HUMULIN R U-500) 1000 Units given intranasally. | 0 | 22 | 0 | 22 | 0 | 22 |
|
| Severe hypoglycemia [600 units] | Endocrine disorders | Systematic Assessment | Less than or equal to 45 mg/dL |
|
Not provided
Not provided
Not provided
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