IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase

PHASE2TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

October 23, 2019

Primary Completion Date

April 8, 2020

Study Completion Date

April 8, 2020

Conditions
Type1diabetes
Interventions
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 its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain.

Trial Locations (1)

55416

Health Partners Institute dba International Diabetes Center, Minneapolis

Sponsors
All Listed Sponsors
collaborator

International Diabetes Center at Park Nicollet

OTHER

collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

HealthPartners Institute

OTHER