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: 1. Primary: a. To assess non-inferiority of dangerous hypoglycemia with administration of intranasal insulin in T1D participants with intact awareness of hypoglycemia. 2. Secondary: 1. To describe changes in overall glycemic control with administration of intranasal insulin in T1D participants with intact awareness of hypoglycemia 2. To describe changes in hypoglycemia awareness with administration of intranasal insulin in T1D participants with intact awareness of hypoglycemia 3. To describe changes in safety endpoints with administration of intranasal insulin in T1D participants with intact awareness of hypoglycemia. 3. Exploratory: 1. To describe changes in memory, attention and executive function with administration of intranasal insulin in T1D participants with intact awareness of hypoglycemia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes.
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.
Health Partners Institute dba International Diabetes Center
Minneapolis, Minnesota, United States
Percentage of Time With Dangerous Hypoglycemia
Defined using percent time below range (\<54 mg/dL), from real-time continuous glucose monitoring (CGM)
Time frame: Two 14-20 day treatment periods
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)
Time frame: Two 14-20 day treatment periods
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Two 14-20 day treatment periods
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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.
Time frame: Two 14-20 day treatment periods
Glucose Management Indicator (GMI)
An approximate HbA1c based upon real-time continuous glucose monitoring (CGM) values
Time frame: Two 14-20 day treatment periods