Trial Outcomes & Findings for IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase (NCT NCT04028960)
NCT ID: NCT04028960
Last Updated: 2021-05-18
Results Overview
Defined using percent time below range (\<54 mg/dL), from real-time continuous glucose monitoring (CGM)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Two 14-20 day treatment periods
Results posted on
2021-05-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase
Baseline characteristics by cohort
| Measure |
Placebo, Then Humulin-R Insulin
n=2 Participants
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.
|
Humulin-R Insulin, Then Placebo
n=2 Participants
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.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two 14-20 day treatment periodsDefined using percent time below range (\<54 mg/dL), from real-time continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Percentage of Time With Dangerous Hypoglycemia
|
0.57 percentage of time
Standard Deviation 0.73
|
0.77 percentage of time
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsDefined using percent of Blood Glucose 70-180 mg/dL from real-time continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Percent of Time With Blood Glucose 70-180 mg/dL
|
51.6 percentage of time
Standard Deviation 16.3
|
49.5 percentage of time
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsDefined using percent of Blood Glucose \<70 mg/dL from real-time continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Percentage of Time With Blood Glucose <70 mg/dL
|
2.0 percentage of time
Standard Deviation 1.7
|
1.6 percentage of time
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsPercentage of time Blood Glucose \>180 mg/dL from real-time continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Percentage of Time Blood Glucose >180 mg/dL
|
25.2 percentage of time
Standard Deviation 2.1
|
26.3 percentage of time
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsPercentage of time with Blood Glucose \>250 mg/dL from real-time continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Percentage of Time With Blood Glucose >250 mg/dL
|
20.6 percentage of time
Standard Deviation 17.7
|
21.9 percentage of time
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsPercentage of time Participant had Active Sensor Wear from real-time continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Percentage of Time Participant Had Active Sensor Wear
|
92.3 percentage of time
Standard Deviation 9.2
|
93.5 percentage of time
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsMean Glucose from the Study Participants from real-time continuous glucose monitoring (CGM)
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Mean Glucose From the Study Participants
|
188.4 mg/dL
Standard Deviation 38.9
|
190.5 mg/dL
Standard Deviation 50.9
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsThe 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.
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Coefficient of Variation (%CV) of Blood Glucose Values From CGM Data
|
40.0 percentage of CV
Standard Deviation 6.5
|
37.8 percentage of CV
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Two 14-20 day treatment periodsAn approximate HbA1c based upon real-time continuous glucose monitoring (CGM) values
Outcome measures
| Measure |
Placebo
n=4 Participants
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.
|
Humulin-R
n=4 Participants
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.
|
|---|---|---|
|
Glucose Management Indicator (GMI)
|
7.8 percentage of HbA1c
Standard Deviation 0.9
|
7.9 percentage of HbA1c
Standard Deviation 1.2
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Humulin-R
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
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.
|
Humulin-R
n=4 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Nose Bleeds
|
75.0%
3/4 • Number of events 10 • 5.5 months
|
100.0%
4/4 • Number of events 7 • 5.5 months
|
|
Skin and subcutaneous tissue disorders
Nasal Irritation
|
0.00%
0/4 • 5.5 months
|
25.0%
1/4 • Number of events 7 • 5.5 months
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 5.5 months
|
25.0%
1/4 • Number of events 2 • 5.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory/Sinus Symptoms
|
25.0%
1/4 • Number of events 3 • 5.5 months
|
0.00%
0/4 • 5.5 months
|
Additional Information
Anders Carlson, MD
HealthPartners Institute dba International Diabetes Center
Phone: 952-993-1927
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place