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Funding was rescinded
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| Name | Class |
|---|---|
| International Diabetes Center at Park Nicollet | OTHER |
| Juvenile Diabetes Research Foundation | OTHER |
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The purpose of this study is to determine how Humulin-R regular insulin affects the body's ability to feel low blood sugar (hypoglycemia) when delivered intranasally compared to placebo in subjects with Type 1 Diabetes (T1D) with hypoglycemia awareness. The study will use continuous glucose monitoring (CGM) to collect this information. The study drug or placebo will be administered using an intranasal device.
Hypoglycemia occurs with high frequency among patients with T1D. With repeated episodes of hypoglycemia, the counter-regulatory pathways to restore normal glucose are blunted, and patients can become unaware of the hypoglycemia. It is estimated that 40% of patients with T1D have hypoglycemia unawareness.
The study has the following objectives:
Primary:
a. To assess non-inferiority of dangerous hypoglycemia with administration of intranasal insulin in T1D participants with intact awareness of hypoglycemia.
Secondary:
Exploratory:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | No active drug |
|
| Humulin-R | Experimental | Insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular insulin (Humulin-R), intranasal route | Drug | Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time With Dangerous Hypoglycemia | Defined using percent time below range (<54 mg/dL), from real-time continuous glucose monitoring (CGM) | Two 14-20 day treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time With Blood Glucose 70-180 mg/dL | Defined using percent of Blood Glucose 70-180 mg/dL from real-time continuous glucose monitoring (CGM) | Two 14-20 day treatment periods |
| Percentage of Time With Blood Glucose <70 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders L Carlson, MD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Partners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Humulin-R Insulin | Participants first received a Placebo using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received Humulin-R Insulin using the SipNose device twice daily for 14-20 days. SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. |
| FG001 | Humulin-R Insulin, Then Placebo | Participants first received Humulin-R Insulin using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received a Placebo using the SipNose device twice daily for 14-20 days. Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes. SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Four subjects were enrolled in the study. Two subjects started the study in the placebo arm and the other two started the study in the Humulin-R arm. During the study, each participant crossed over to the opposite arm of the study so that each subject participated in both arms of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Then Humulin-R Insulin | Participants first received a Placebo using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received Humulin-R Insulin using the SipNose device twice daily for 14-20 days. SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. |
| 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 | Percentage of Time With Dangerous Hypoglycemia | Defined using percent time below range (<54 mg/dL), from real-time continuous glucose monitoring (CGM) | Posted | Mean | Standard Deviation | percentage of time | Two 14-20 day treatment periods |
|
5.5 months
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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 | Placebo | No active drug SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nose Bleeds | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
The study team was unable to draw conclusions at this time regarding the cognitive testing performed due to abbreviated funding which led to a small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anders Carlson, MD | HealthPartners Institute dba International Diabetes Center | 952-993-1927 | Anders.L.Carlson@HealthPartners.Com |
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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 | Apr 7, 2020 | Mar 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| SipNose intranasal device | Device | The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. |
|
Defined using percent of Blood Glucose <70 mg/dL from real-time continuous glucose monitoring (CGM)
| Two 14-20 day treatment periods |
| Percentage of Time Blood Glucose >180 mg/dL | Percentage of time Blood Glucose >180 mg/dL from real-time continuous glucose monitoring (CGM) | Two 14-20 day treatment periods |
| Percentage of Time With Blood Glucose >250 mg/dL | Percentage of time with Blood Glucose >250 mg/dL from real-time continuous glucose monitoring (CGM) | Two 14-20 day treatment periods |
| Percentage of Time Participant Had Active Sensor Wear | Percentage of time Participant had Active Sensor Wear from real-time continuous glucose monitoring (CGM) | Two 14-20 day treatment periods |
| Mean Glucose From the Study Participants | Mean Glucose from the Study Participants from real-time continuous glucose monitoring (CGM) | Two 14-20 day treatment periods |
| Coefficient of Variation (%CV) of Blood Glucose Values From CGM Data | The Coefficient of variation was calculated by dividing the standard deviation of blood glucose values by the mean of the blood glucose values based on data from the corresponding CGM readings. | Two 14-20 day treatment periods |
| Glucose Management Indicator (GMI) | An approximate HbA1c based upon real-time continuous glucose monitoring (CGM) values | Two 14-20 day treatment periods |
| BG001 | Humulin-R Insulin, Then Placebo | Participants first received Humilin-R Insulin using the SipNose device twice daily for 14-20 days. After a washout period of 2 weeks, they received a Placebo using the SipNose device twice daily for 14-20 days. Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes. SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Humulin-R | Insulin Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes. SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. |
|
|
| Secondary | Percent of Time With Blood Glucose 70-180 mg/dL | Defined using percent of Blood Glucose 70-180 mg/dL from real-time continuous glucose monitoring (CGM) | Posted | Mean | Standard Deviation | percentage of time | Two 14-20 day treatment periods |
|
|
|
| Secondary | Percentage of Time With Blood Glucose <70 mg/dL | Defined using percent of Blood Glucose <70 mg/dL from real-time continuous glucose monitoring (CGM) | Posted | Mean | Standard Deviation | percentage of time | Two 14-20 day treatment periods |
|
|
|
| Secondary | Percentage of Time Blood Glucose >180 mg/dL | Percentage of time Blood Glucose >180 mg/dL from real-time continuous glucose monitoring (CGM) | Posted | Mean | Standard Deviation | percentage of time | Two 14-20 day treatment periods |
|
|
|
| Secondary | Percentage of Time With Blood Glucose >250 mg/dL | Percentage of time with Blood Glucose >250 mg/dL from real-time continuous glucose monitoring (CGM) | Posted | Mean | Standard Deviation | percentage of time | Two 14-20 day treatment periods |
|
|
|
| Secondary | Percentage of Time Participant Had Active Sensor Wear | Percentage of time Participant had Active Sensor Wear from real-time continuous glucose monitoring (CGM) | Posted | Mean | Standard Deviation | percentage of time | Two 14-20 day treatment periods |
|
|
|
| Secondary | Mean Glucose From the Study Participants | Mean Glucose from the Study Participants from real-time continuous glucose monitoring (CGM) | Posted | Mean | Standard Deviation | mg/dL | Two 14-20 day treatment periods |
|
|
|
| Secondary | Coefficient of Variation (%CV) of Blood Glucose Values From CGM Data | The Coefficient of variation was calculated by dividing the standard deviation of blood glucose values by the mean of the blood glucose values based on data from the corresponding CGM readings. | Posted | Mean | Standard Deviation | percentage of CV | Two 14-20 day treatment periods |
|
|
|
| Secondary | Glucose Management Indicator (GMI) | An approximate HbA1c based upon real-time continuous glucose monitoring (CGM) values | Posted | Mean | Standard Deviation | percentage of HbA1c | Two 14-20 day treatment periods |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 3 |
| 4 |
| EG001 | Humulin-R | Insulin Regular insulin (Humulin-R), intranasal route: Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes. SipNose intranasal device: The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain. | 0 | 4 | 0 | 4 | 4 | 4 |
| Nasal Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Respiratory/Sinus Symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |