“IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase”
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.
Drug - 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.
Device - 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 ...read more on ClinicalTrials.org
Intranasal Insulin: A Novel Therapy for Hypoglycemia Unawareness in Type 1 Diabetes