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Glucagon-like peptide-1 receptor agonist
Semaglutide for Type 2 Diabetes
Phase 4
Waitlist Available
Led By Francis Kim, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women 40-65 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights
Study Summary
This trial will study the effect of a diabetes medication, semaglutide, on blood flow and permeability in the brain of people with Type-2 diabetes.
Who is the study for?
This trial is for men and women aged 40-65 with type-2 diabetes for at least 3 years, HbA1C levels between 7%-10%, and on stable blood sugar control medications. Excluded are those needing high insulin doses, pregnant or breastfeeding women, individuals with uncontrolled hypertension, a history of pancreatitis or certain cardiovascular events, family history of specific carcinomas or syndromes, severe kidney issues, recent pioglitazone treatment, or contraindications to MRI.Check my eligibility
What is being tested?
The study tests the effects of Semaglutide versus placebo on intracranial blood flow and brain-barrier permeability in people with type-2 diabetes. Participants will be randomly assigned to receive either Semaglutide via auto-injector or a placebo. The main outcome will be measured using magnetic resonance images taken at baseline and after one year.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Semaglutide components; however specific side effects are not listed here. As this drug class has been associated with stroke reduction but also risks like pancreatitis in some cases, monitoring for various symptoms would be important.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intracranial blood flow (IBF)
bloodbrain barrier Ktrans
Secondary outcome measures
Inflammatory markers
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Subjects randomized to semaglutide for 1 year.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to placebo for 1 year.
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Who is running the clinical trial?
Novo Nordisk A/SIndustry Sponsor
1,513 Previous Clinical Trials
2,414,979 Total Patients Enrolled
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,301 Total Patients Enrolled
Francis Kim, MDPrincipal InvestigatorUniversity of Washington
5 Previous Clinical Trials
3,117 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken pioglitazone in the last 3 months.I have had pancreatitis before.I am not pregnant, breastfeeding, or planning to become pregnant in the next 15 months.I or my family have a history of Medullary Thyroid Cancer or MEN 2.I cannot monitor my blood sugar levels at home.I have had type-2 diabetes for 3+ years and my HbA1C is between 7%-10% while on medication.I am between 40 and 65 years old.Your blood pressure is not well controlled, with readings higher than 180/100 mmHg.I have had a heart attack, stroke, or a mini-stroke.My kidney function is low, with an eGFR under 45.You are allergic to semaglutide or any of the ingredients in the product.My LDL cholesterol is over 130 mg/dL or I haven't been on a consistent statin treatment recently.My health condition is currently stable.I use more than 100 units of insulin daily.I am currently taking a medication similar to the study drug.You cannot have an MRI or contrast agent for medical reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Active
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is a prerequisite of this trial that applicants must be under 75 years old?
"This research is recruiting individuals aged between 40 and 65 years old."
Answered by AI
Has the FDA endorsed Active for commercialization?
"Taking into account that this is a Phase 4 trial, which implies its approval by the relevant regulatory body, Active has been assigned an elevated safety rating of 3."
Answered by AI
Is there an opportunity for me to participate in this research endeavor?
"Potential participants for this research must have type 2 diabetes, be between 40 and 65 years of age, and the trial is aiming to recruit around 50 individuals."
Answered by AI
Is this experiment recruiting participants currently?
"This investigation, which was published on April 3rd 2023 and last amended on March 10th 2023, is no longer recruiting participants. Nevertheless, there are currently 1,450 other clinical trials that require volunteers to help with their research endeavours."
Answered by AI
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