NCT04292535

Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Michigan State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.

Conditions

• Insulin
• Exercise

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2020-03-03
• Last updated: 2021-06-21
• Results posted: 2021-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study