CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
Placebo into the intranasal mucosa +6 moredrug
Likely dose
20 IU NovoLog Insulin aspart into the intranasal mucosafrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04292535
NCT04292535Phase 2Completed
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Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

Michigan State University·interventional·Posted Mar 3, 2020·Updated Jun 21, 2021

In Brief

A Phase 2 clinical trial evaluating Placebo into the intranasal mucosa, 20 IU NovoLog Insulin aspart into the intranasal mucosa, and 5 other interventions for Insulin and Exercise. Completed, enrolled 116 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsulin, Exercise
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 3, 2020
Enrollment StartJun 15, 2018
Primary CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.3 years ago

Interventions

Placebo into the intranasal mucosadrug

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

20 IU NovoLog Insulin aspart into the intranasal mucosadrug

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

40 IU NovoLog Insulin aspart into the intranasal mucosadrug

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

60 IU NovoLog Insulin aspart into the intranasal mucosadrug

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

80 IU NovoLog Insulin aspart into the intranasal mucosadrug

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

100 IU NovoLog Insulin aspart into the intranasal mucosadrug

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

120 IU NovoLog Insulin aspart into the intranasal mucosadrug

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