Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants

NCT05062785 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HUM00171279
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine the safety and tolerability of regular insulin (Humulin R) when given intranasally (as drops in nostrils). Healthy participants will be enrolled to determine the maximum tolerated dose of intranasal insulin.

Conditions

Out-Of-Hospital Cardiac Arrest; Healthy

Keywords

Healthy participants; intranasal insulin

Outcome Measures

Primary Outcomes (1)

• Severe Hypoglycemia

  Results reflect the participants who experienced severe hypoglycemia generically at the time they received a dose of insulin, as defined by blood glucose \< 45 milligrams per deciliter (mg/dL). Severe hypoglycemia was considered a dose limiting toxicity (DLT).

  Within 4 hours of dosing during each of 5 visits

Secondary Outcomes (30)

• Change in Blood Glucose - Study Visit 1 (100 Units)

  Baseline and up to 4 hours after drug administration (Study Visit 1, Day 1)

• Change in Blood Glucose - Study Visit 1 (200 Units)

  Baseline, up to 4 hours after drug administration

• Change in Blood Glucose - Study Visit 1 (400 Units)

  Baseline, up to 4 hours after drug administration

• Change in Blood Glucose - Study Visit 2 (400 Units)

  Baseline, up to 4 hours after drug administration

• Change in Blood Glucose - Study Visit 2 (600 Units)

  Baseline, up to 4 hours after drug administration

Study Arms (1)

Intranasal insulin

EXPERIMENTAL

A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin.

Drug: Intranasal insulin

Interventions

Intranasal insulin DRUG

This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits. On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a a 4 hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.

Also known as: HUMULIN R U-500

Intranasal insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good health based on medical history, physical exam, and routine laboratory testing.
• Female participants must have negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age \> 45 years with the absence of menses for greater than 12 months. Tubal ligation with menses within the past 12 months is not considered to be surgical sterilization.
• Body mass index (BMI) between 18 kilogram / square meter (kg/m2) and 35 kg/m2.
• Willing and able to stay at the clinical research facility as required by the protocol
• Willing and able to comply with the investigational nature of the study and able to communicate well with investigators
• Ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines

You may not qualify if:

• Known allergy to insulin.
• Preexisting diabetes.
• Current or previous use of diabetes medication or insulin.
• Any nasal disease or congestion that may interfere with intranasal drug absorption.
• Baseline hypoglycemia (blood glucose ≤ 65 mg/dL) or hyperglycemia (blood glucose \> 200 mg/dL) as evident from the screening labs.
• Active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness
• Blood donation in excess of 500 milliliter (mL) within 60 days prior to the first dose of study medication.
• Treated with an investigational drug within 30 days.
• Individuals with inadequate venous access.

Sponsors & Collaborators

• Robert Silbergleit: lead
• American Heart Association: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Links

• Link to a complete de-identified participant-level dataset archived in the University of Michigan Deep Blue Repository consistent with the Open Science standards of the American Heart Society

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Robert Silbergleit
• Organization: University of Michigan

robie@med.umich.edu

734-936-6284

Study Officials

• Robert Silbergleit, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Model Details: For every 6 participants, iterations of a Bayesian model will be performed to associate the administered dose with the frequency of dose-limiting hypoglycemia or other adverse events. The model will adaptively reallocate the dose increments for the next 6 participants. To provide more precise and reproducible estimates of dose-limiting toxicity, the trial will modify the size of dose increments based on the developing model to allocate more administrations to areas of the model with greatest uncertainty, or to higher doses in the absence of dose-limiting hypoglycemia.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 30, 2021
• Study Start: October 4, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)