Phase 1
N=24
Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants
Out-Of-Hospital Cardiac Arrest · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05062785 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Severe Hypoglycemia — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Intranasal insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Robert Silbergleit
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severe Hypoglycemia |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Blood Glucose - Study Visit 1 (100 Units) |
94.8; 92.5; 91.8; 90.0; 88.0; 91.5 | — |
| SECONDARY Change in Blood Glucose - Study Visit 1 (200 Units) |
79; 94.2; 90.2; 77.5; 90.8; 93.8 | — |
| SECONDARY Change in Blood Glucose - Study Visit 1 (400 Units) |
95.8; 97.0; 93.8; 96.3; 92.3; 91.2 | — |
| SECONDARY Change in Blood Glucose - Study Visit 2 (400 Units) |
83.8; 88.3; 93.3; 84.8; 91.7; 88.7 | — |
| SECONDARY Change in Blood Glucose - Study Visit 2 (600 Units) |
93.6; 93.8; 85.0; 97.0; 94.8; 93.8 | — |
| SECONDARY Change in Blood Glucose - Study Visit 3 (600 Units) |
82.5; 94.5; 94.2; 86.2; 88.0; 96.8 | — |
| SECONDARY Change in Blood Glucose - Study Visit 3 (800 Units) |
97.8; 97.6; 97.2; 97.0; 101.6; 95.8 | — |
| SECONDARY Change in Blood Glucose - Study Visit 4 (800 Units) |
87.8; 98.8; 91.2; 82.2; 90.5; 87.7 | — |
| SECONDARY Change in Blood Glucose - Study Visit 4 (900 Units) |
100.8; 101.2; 93.8; 93.2; 97.6; 98.6 | — |
| SECONDARY Change in Blood Glucose - Study Visit 5 (1000 Units) |
86.6; 90.8; 96.2; 100.4; 82.6; 90.8 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 1 (100 Units) |
0.8; 0.9; 0.8; 0.8; 0.7; 0.7 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 1 (200 Units) |
1.0; 2.5; 1.2; 1.0; 2.2; 1.2 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 1 (400 Units) |
2.2; 1.9; 1.9; 1.7; 1.6; 1.4 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 2 (400 Units) |
1.4; 2.4; 2.1; 1.3; 2.0; 1.7 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 2 (600 Units) |
2.6; 2.2; 2.0; 1.7; 2.5; 1.9 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 3 (600 Units) |
1.33; 2.8; 2.9; 1.24; 2.4; 2.4 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 3 (800 Units) |
5.2; 3.2; 2.8; 2.4; 2.2; 2.0 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 4 (800 Units) |
1.2; 3.2; 2.4; 1.1; 2.4; 1.9 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 4 (900 Units) |
2.9; 2.4; 2.2; 1.9; 1.9; 1.8 | — |
| SECONDARY Change in Serum C-peptide Levels - Study Visit 5 (1000 Units) |
1.8; 2.8; 2.7; 3.1; 1.3; 2.4 | — |
| SECONDARY Change in Serum Insulin - Study Visit 1 (100 Units) |
4.9; 6.2; 5.8; 5.2; 5.6; 4.7 | — |
| SECONDARY Change in Serum Insulin - Study Visit 1 (200 Units) |
7.1; 19.5; 7.8; 9.5; 18.0; 11.7 | — |
| SECONDARY Change in Serum Insulin - Study Visit 1 (400 Units) |
15.5; 14.3; 15.5; 14.4; 12.3; 9.7 | — |
| SECONDARY Change in Serum Insulin - Study Visit 2 (400 Units) |
8.2; 16.6; 12.2; 10.8; 16.5; 13.9 | — |
| SECONDARY Change in Serum Insulin - Study Visit 2 (600 Units) |
16.8; 24.6; 19.7; 20.7; 17.4; 13.5 | — |
| SECONDARY Change in Serum Insulin - Study Visit 3 (600 Units) |
6.8; 19.8; 14.3; 30.7; 18.2; 14.7 | — |
| SECONDARY Change in Serum Insulin - Study Visit 3 (800 Units) |
31.0; 25.3; 23.0; 18.6; 16.2; 15.0 | — |
| SECONDARY Change in Serum Insulin - Study Visit 4 (800 Units) |
6.7; 21.5; 10.2; 7.8; 20.8; 16.5 | — |
| SECONDARY Change in Serum Insulin - Study Visit 4 (900 Units) |
22.9; 27.1; 24.7; 22.0; 18.8; 17.9 | — |
| SECONDARY Change in Serum Insulin - Study Visit 5 (1000 Units) |
7.1; 18.9; 14.8; 19.5; 7.8; 20.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05062785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.