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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 below

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My type 2 diabetes is not well-controlled with my current treatment.

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I have a history of heart or blood vessel disease.

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I am overweight with a BMI of 27 or higher and have a related health issue like high blood pressure.

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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:

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I have been diagnosed with HIV.

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I have severe heart failure symptoms.

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I have a severe liver condition.

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I or someone in my family has had medullary thyroid cancer.

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I have been diagnosed with Multiple Endocrine Neoplasia type 2.

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I am currently pregnant, planning to become pregnant, or breastfeeding.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

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.

0 / 14Eligibility criteria met