Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes

NCT05780905 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY00016594U1111-1271-3352
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A human subjects research study, the primary purpose of which is to assess the EFFECTS OF SEMAGLUTIDE ON INTRACRANIAL BLOOD FLOW AND BLOOD-BRAIN BARRIER PERMEABILITY IN TYPE-2 DIABETES (T2D) through testing of the intervention on patients in a clinical setting. The study will randomize subjects with diabetes to either semaglutide or matching placebo. Magnetic resonance images will be primary endpoint measured at baseline and at one year to assess effect of this FDA approved medication. Given the available evidence supporting the neuroprotective effect of this drug class and stroke reduction with semaglutide, and the investigators preliminary data showing that T2D had significantly reduced total number of distal arterial branches in the brain than non-T2D, the investigators expect treatment with semaglutide will be associated with improved intracranial blood flow condition.

Conditions

Diabetes Mellitus, Type 2; Stroke (CVA) or Transient Ischemic Attack

Outcome Measures

Primary Outcomes (2)

• Intracranial blood flow (IBF)

  measured as total length and number of distal vessels

  Approximately 12 Months

• bloodbrain barrier Ktrans

  measured by dynamic contrast-enhanced MRI

  Approximately 12 Months

Secondary Outcomes (1)

• Inflammatory markers

  Approximately 12 Months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects randomized to placebo for 1 year.

Other: Placebo

Active

ACTIVE COMPARATOR

Subjects randomized to semaglutide for 1 year.

Drug: Semaglutide Auto-Injector

Interventions

Semaglutide Auto-Injector DRUG

Subjects have an equal chance of receiving semaglutide or placebo. Which treatment subjects receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither subjects, Study Site personnel nor image reviewers will know which treatment subjects are assigned to. The study drug must be taken weekly. The subject's other medications may be changed by the study's un-blinded Endocrinologist. At baseline subject will receive and take home 0.25mg injector for use 3 more times. They will be given a 0.5mg injector and a 1mg injector for use beginning 5 and 9 weeks from baseline respectively. The target dose for subjects is 1mg per week up to the 52 week treatment duration.

Also known as: ozempic

Active

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 40-65 years of age
• Subjects with type-2 diabetes \>= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
• Medically stable
• Has not received any investigational drug in the past 6 months
• Willing to participate and sign informed consent.

You may not qualify if:

• Contraindication to MRI or contrast agent
• eGFR\<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
• Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
• Unable to perform home-glucose monitoring
• Currently need more than 100 units of insulin daily
• Uncontrolled hypertension with systolic blood pressure (SBP)\>180 mmHg or diastolic blood pressure (DBP)\>100 mmHg
• LDL-C\>130 mg/dL or not on stable statin therapy in the past 6 months
• Treatment with pioglitazone in the past 3 months
• History of pancreatitis
• History of myocardial infarction, stroke or transient ischemic attack
• History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Hypersensitivity to semaglutide or any of the product components
• Participating in other clinical trial
• Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or who are breastfeeding or who plan to become pregnant in the next 15 months.

Sponsors & Collaborators

• University of Washington: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

University of Washington - Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Stroke; Ischemic Attack, Transient

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Francis Kim, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis Kim, MD

CONTACT

206-744-8305; fkim@u.washington.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Cardiology

Model Details: Randomized, double-blind and placebo controlled MRI study

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: January 11, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

US (1)