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Glucagon-like peptide-1 receptor agonist
Semaglutide for Type 2 Diabetes
Phase 4
Recruiting
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
Must not have
History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
History of pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I or my family have a history of Medullary Thyroid Cancer or MEN 2.
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I have had pancreatitis before.
Select...
I cannot monitor my blood sugar levels at home.
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I have had a heart attack, stroke, or a mini-stroke.
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My kidney function is low, with an eGFR under 45.
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My LDL cholesterol is over 130 mg/dL or I haven't been on a consistent statin treatment recently.
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I use more than 100 units of insulin daily.
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I am currently taking a medication similar to the study drug.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intracranial blood flow (IBF)
bloodbrain barrier Ktrans
Secondary study objectives
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
1,541 Previous Clinical Trials
2,441,020 Total Patients Enrolled
University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,456 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: Active
- Group 2: Placebo
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.
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