Comparing Semaglutide with Nicotine replacement for type 2 diabetes mellitus
Official title: Semaglutide for Smoking Cessation in Patients With Diabetes
Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled Trial
Interventions
Semaglutide
Starting dose will be 0.25mg once a week for 4 weeks, then titrated up to 0.5mg once a week. For those requiring additional blood sugar control, the dose may be titrated up to the maximum dose of 2mg once a week. All participants will use this medication for up to 26 weeks
Nicotine replacement
Nicotine patch plus short-acting NRT gum or lozenge
Canadian Sites (1)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Stable HbA1c ≥7.0% - 10% with no more than a 1% change over the last 3 to 6 months.
- +Adults (18 years or older) with type 2 diabetes
- +Currently residing in Ontario
- +Have not used GLP-1 receptor agonists in the past six months.
- +Able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Smoke at least five cigarettes per day and willing to reduce or quit smoking within the next 6 months
Exclusion
- −Contraindication to NRT or GLP-1 RA.
- −Current daily use of NRT or a GLP1 RA.
- −Use of bupropion, cytisine, and varenicline within the last 7 days.
- −Use of a DPP-IV inhibitor within the last 7 days.
- −Initiation of a new diabetes medication within the last 3 months.
- −As per the product monograph, participants with the following diagnoses or disorders will be excluded;
- −Personal or family history of medullary thyroid cancer
- −Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
- −Diabetic ketoacidosis
- −Type I diabetes
- −Acute pancreatitis or pancreatic cancer
- −Acute, chronic or end-stage renal failure
- −Tachyarrhythmias
- −Unable to engage in follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → for any reason (for example an acute mental illness, cognitive impairment, unable to speak English or French).
- −Other conditions deemed by the study team to interfere with participation or outcomes in the opinion of the study investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (for example acutely unwell, life expectancy less than 1 year).
- −Pregnant or breastfeeding individuals
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Semaglutide, Nicotine replacement.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: 12 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Project success — measured over 12 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07059377 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SemaglutideDrug
Starting dose will be 0.25mg once a week for 4 weeks, then titrated up to 0.5mg once a week. For those requiring additional blood sugar control, the dose may be titrated up to the maximum dose of 2mg once a week. All participants will use this medication for up to 26 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Nicotine replacementDrug
Nicotine patch plus short-acting NRT gum or lozenge
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 months.
The study as a whole is currently expected to finish around 2027-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
To assess the feasibility of conducting a randomized controlled trial (RCT) to determine the effectiveness of semaglutide as an adjunct to combination NRT in supporting smoking cessation for patients with diabetes.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.