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Hormone Therapy

Intra-Nasal Insulin for Diabetes (FIINAAL Trial)

Phase 1
Waitlist Available
Led By Kathryn L Gwizdala, Ph.D.
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

FIINAAL Trial Summary

This trial is looking at how a person's Alzheimer's status (i.e. APOE genotype and cognitive functioning) affects brain insulin's relationship to food intake.

FIINAAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in caloric intake
Change in ingestive behavior constructs
Secondary outcome measures
Amount of adiposity (i.e. DXA) per participant
Characterize AD family history (via a questionnaire)
Number of participants who are APOE e4 carriers versus noncarriers

FIINAAL Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InsulinExperimental Treatment1 Intervention
40 participants will receive 40 IUs of intranasal insulin about 30 minutes before consuming an ad libitum lunch.
Group II: PlaceboPlacebo Group1 Intervention
40 participants will receive 40 IUs of intranasal saline about 30 minutes before consuming an ad libitum lunch.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin, Regular, Human
2021
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
305 Previous Clinical Trials
181,996 Total Patients Enrolled
7 Trials studying Diabetes
1,433 Patients Enrolled for Diabetes
Nutrition Obesity Research CenterUNKNOWN
2 Previous Clinical Trials
48 Total Patients Enrolled
Kathryn L Gwizdala, Ph.D.Principal InvestigatorPennington Biomedical Research Center

Media Library

Insulin, Regular, Human (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04739371 — Phase 1
Diabetes Research Study Groups: Insulin, Placebo
Diabetes Clinical Trial 2023: Insulin, Regular, Human Highlights & Side Effects. Trial Name: NCT04739371 — Phase 1
Insulin, Regular, Human (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04739371 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with using regular insulin for human patients?

"Insulin, Regular, Human is still in Phase 1 trials, so there is very little data currently available to support its safety or efficacy. Our team at Power gave it a score of 1."

Answered by AI

Are there other ongoing or completed studies involving Insulin, Regular, Human?

"Currently, there are 80 different clinical trials underway that are testing the efficacy of insulin regular human. Of those 80 trials, 13 are in Phase 3. Although a large number of the trials are based in Manhasset, New york, there are a total of 257 sites running these tests."

Answered by AI

Does this research study allow for patients that are above the age of 20?

"The minimum age limit to enroll in this particular trial is 45 years old whereas the maximum age is 65."

Answered by AI

Are we able to enroll more patients in this experiment?

"The clinical trial in question, which was first brought to public attention on June 17th, 2021, is not currently seeking volunteers. That being said, there are 84 other trials which are currently looking for participants."

Answered by AI

How many people can potentially enroll in this research project?

"This study is not currently enrolling patients but was last updated on 8/16/2022. There are 4 other trials involving insulin that are actively recruiting patients."

Answered by AI
~10 spots leftby May 2025