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Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

NCT04292535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2021-06-21

Study results available
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Summary

To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

Conditions

  • Insulin
  • Exercise

Interventions

DRUG

Placebo into the intranasal mucosa

6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer

DRUG

20 IU NovoLog Insulin aspart into the intranasal mucosa

5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

DRUG

40 IU NovoLog Insulin aspart into the intranasal mucosa

4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

DRUG

60 IU NovoLog Insulin aspart into the intranasal mucosa

3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

DRUG

80 IU NovoLog Insulin aspart into the intranasal mucosa

2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

DRUG

100 IU NovoLog Insulin aspart into the intranasal mucosa

1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

DRUG

120 IU NovoLog Insulin aspart into the intranasal mucosa

6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Sponsors & Collaborators

Principal Investigators

  • Matthew B Pontifex, Ph.D. · Michigan State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2020-02-20
Completion
2020-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04292535 on ClinicalTrials.gov