Health TrialsbyHealthPanel

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

ConditionsDiabetes Mellitus, Type 2Stroke (CVA) or Transient Ischemic Attack
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Other intervention

    Placebo

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ActiveActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intracranial blood flow (IBF)

measured as total length and number of distal vessels

Time frame
Approximately 12 Months
2

bloodbrain barrier Ktrans

measured by dynamic contrast-enhanced MRI

Time frame
Approximately 12 Months

Secondary outcomes

1

Inflammatory markers

hsCRP, interleukin-6 and tumor necrosis factor -a

Time frame
Approximately 12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Novo Nordisk A/S

Collaborator

Source ClinicalTrials.gov
Apply now