Clinical trial

Phase 1, Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional MRI

Name

HUM00230748

Description

The purpose of this trial is to study the brain response using functional MRI (fMRI) before and after varying doses of insulin given through the nose. The magnetic resonance imaging uses a very strong magnet to produce images of participant's brain. It becomes a functional MRI when the study team looks at the activity within the brain (blood flow / change in metabolism).

Trial arms

Trial start

2023-11-17

Estimated PCD

2024-02-22

Trial end

2024-02-22

Status

Completed

Phase

Early phase I

Treatment

Intranasal insulin

Enrolled Participants for this trial will come for 3 study visits. The doses will be administered in varying order: participants will be randomized to one six possible permutations of the intranasal study doses (0, 500, 1000 U) of intranasal insulin at each visit. Participants will undergo a fMRI scan before and after receiving intranasal doses. Additionally, participants will have blood samples taken.

Arms:

Intranasal insulin and placebo

Other names:

HUMULIN R U-500

Size

Primary endpoint

Change in Signal response using fMRI after administration of intranasal insulin

Baseline fMRI (approximately 30 minutes), fMRI Approximately 30 minutes (after insulin dose administration)

Eligibility criteria

Inclusion Criteria: * Participants in good health based on medical history, physical exam, and routine laboratory testing * Female participants must have a 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. * Body mass index (BMI) between 18 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 * Ability to lie flat for a minimum of 2-hours 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 milligrams per deciliter (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 * Treated with an investigational drug within 30 days. * Individuals with inadequate venous access. * Claustrophobic, uncontrollable shaking, or unable to lie still for a lengthy period. * Any metals or implanted devices within the body. * Any foreign metallic objects in the body. * Females that are pregnant, trying to become pregnant, or breastfeeding

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each volunteer will have 3 study visits, receiving a different study dose at each visit in randomized order as spelled out in the protocol.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

Updated at

2024-03-21

1 organization

1 product

1 indication

Organization

Florian Schmitzberger

Product

Intranasal insulin

Indication

Healthy