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

NCT04028960 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-05-18

Study results available
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Summary

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.

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.

Sponsors & Collaborators

  • International Diabetes Center at Park Nicollet

    collaborator OTHER

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Anders L Carlson, MD · HealthPartners Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2020-04-08
Completion
2020-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028960 on ClinicalTrials.gov