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Glucagon-like peptide-1 receptor agonist
Semaglutide for Type 2 Diabetes (SEMA-VR Trial)
Phase 4
Recruiting
Led By Subodh Verma, MD, PhD
Research Sponsored by Canadian Medical and Surgical Knowledge Translation Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented T2D with inadequate glycemic control
History of ASCVD: Documented coronary artery disease, cerebrovascular or carotid disease, peripheral artery disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months post-randomization
Awards & highlights
SEMA-VR Trial Summary
This trial will study the effects of semaglutide on vessel-repairing cells in people with type 2 diabetes/obesity. Participants will receive semaglutide or usual care and provide blood samples at baseline & 6 months.
Who is the study for?
This trial is for adults over 18 with type 2 diabetes or obesity, who are overweight (BMI ≥ 27 kg/m^2) and have related health issues like high blood pressure. It's not for pregnant women, those with severe infections or liver disease, a history of certain cancers or thyroid conditions, heart failure symptoms, uncontrolled diabetes (HbA1c > 11.0%), or anyone currently on similar medications.Check my eligibility
What is being tested?
The SEMA-VR study tests if semaglutide can help protect the heart in people with type 2 diabetes/obesity by increasing vessel-repairing cells. Participants will either get escalating doses of semaglutide up to 1 mg/week or usual care without it for six months and provide blood samples at the start and end.See study design
What are the potential side effects?
Semaglutide may cause side effects such as digestive problems (nausea, vomiting), low blood sugar levels especially when taken with other diabetes medicines, pancreatitis, changes in vision due to diabetic retinopathy complications, kidney problems including kidney failure.
SEMA-VR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My type 2 diabetes is not well-controlled with my current treatment.
Select...
I have a history of heart or blood vessel disease.
Select...
I am overweight with a BMI of 27 or higher and have a related health issue like high blood pressure.
Select...
I am 18 or older and qualify for semaglutide injections according to Health Canada.
SEMA-VR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in the mean frequency (%) of circulating ALDHhiSSClow primitive progenitor cells in individuals treated with semaglutide versus usual care for 6 months
Secondary outcome measures
Changes in the frequency (%) of circulating ALDHhiSSChi pro-inflammatory granulocyte precursors in individuals treated with semaglutide versus usual care for 6 months
Changes in the frequency (%) of circulating ALDHhiSSCmid pro-inflammatory monocytes in individuals treated with semaglutide versus usual care for 6 months
Changes in the mean frequency (%) of circulating ALDHhiSSCmid pro-vascular monocytes in individuals treated with semaglutide versus usual care for 6 months
Side effects data
From 2018 Phase 3 trial • 458 Patients • NCT0301522029%
Nasopharyngitis
9%
Constipation
9%
Nausea
8%
Upper respiratory tract inflammation
6%
Back pain
6%
Diarrhoea
5%
Decreased appetite
3%
Influenza
3%
Diabetic retinopathy
2%
Atrioventricular block second degree
2%
Abdominal discomfort
2%
Vomiting
2%
Angina pectoris
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dulaglutide 0.75 mg
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
SEMA-VR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive once-weekly semaglutide subcutaneous injection [Ozempic] at escalating doses from 0.25 mg/week, 0.5 mg/week, to 1.0 mg/week.
Group II: Usual careActive Control1 Intervention
Participants will continue to receive other usual medications, rehabilitation, procedures, and interventions as recommended by their healthcare providers.
Find a Location
Who is running the clinical trial?
Canadian Medical and Surgical Knowledge Translation Research GroupLead Sponsor
8 Previous Clinical Trials
839 Total Patients Enrolled
Unity Health TorontoOTHER
540 Previous Clinical Trials
447,680 Total Patients Enrolled
Western University, CanadaOTHER
239 Previous Clinical Trials
56,821 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health issues that could interfere with the study.I have been diagnosed with HIV.I have severe heart failure symptoms.My type 2 diabetes is not well-controlled with my current treatment.I have a severe liver condition.I or someone in my family has had medullary thyroid cancer.I have been diagnosed with Multiple Endocrine Neoplasia type 2.I don't have heart disease but have two or more risk factors like smoking, high blood pressure, being overweight, kidney issues, high cholesterol, high triglycerides, low HDL, high inflammation levels, albumin in urine, or I'm South Asian.Your HbA1c level is higher than 11.0%.I have a history of heart or blood vessel disease.I am currently pregnant, planning to become pregnant, or breastfeeding.I am currently being treated for an infection.Your white blood cell count is higher than 15 x 10^9/L.I have been cancer-free for the last 5 years, except for basal cell skin cancer.I am overweight with a BMI of 27 or higher and have a related health issue like high blood pressure.I am 18 or older and qualify for semaglutide injections according to Health Canada.I am currently using or have used a GLP-1 receptor agonist.I am currently taking oral steroids or other drugs that suppress my immune system.You have a body mass index (BMI) of 30 or higher, which means you are classified as obese.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide
- Group 2: Usual care
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Has Semaglutide been given the green light by the FDA?
"A score of 3 was assigned to semaglutide's safety since it has completed phase 4 clinical trials and is consequently approved for use."
Answered by AI
Are there still positions available for participants in this research?
"That is correct. According to records stored on clinicaltrials.gov, this medical investigation was first released on April 29th 2023 and has since been updated in mid-May of the same year. The research team seeks a total of 100 participants at two different sites."
Answered by AI
How many individuals have been accepted to take part in this investigation?
"Affirmative. Evidence on clinicaltrials.gov specifies that this trial, first posted in April 29th 2023, is actively searching for applicants. At 2 separate sites, a total of 100 participants need to be enrolled in the study."
Answered by AI
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