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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
Must not have
Known acquired immunodeficiency syndrome such as HIV
New York Heart Association class IV symptoms of heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with HIV.
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I have severe heart failure symptoms.
Select...
I have a severe liver condition.
Select...
I or someone in my family has had medullary thyroid cancer.
Select...
I have been diagnosed with Multiple Endocrine Neoplasia type 2.
Select...
I am currently pregnant, planning to become pregnant, or breastfeeding.
Select...
I am currently being treated for an infection.
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I have been cancer-free for the last 5 years, except for basal cell skin cancer.
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I am currently using or have used a GLP-1 receptor agonist.
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I am currently taking oral steroids or other drugs that suppress my immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2018 Phase 3 trial • 458 Patients • NCT0301522026%
Nasopharyngitis
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Back pain
3%
Upper respiratory tract inflammation
2%
Abdominal discomfort
2%
Vomiting
2%
Diarrhoea
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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
10 Previous Clinical Trials
919 Total Patients Enrolled
Unity Health TorontoOTHER
556 Previous Clinical Trials
454,306 Total Patients Enrolled
Western University, CanadaOTHER
252 Previous Clinical Trials
58,392 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:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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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