Diabetes Mellitus, Type 2Phase 3GLP1-SCNCT07059377
Semaglutide for Smoking Cessation in Patients With Diabetes
A Phase 3 study testing Semaglutide and Nicotine replacement in people with Diabetes Mellitus, Type 2 and Nicotine Addiction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Nicotine Addiction, Tobacco Dependence
- What is being tested?
- Semaglutide and Nicotine replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2026to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years or older) with type 2 diabetes
- Currently residing in Ontario
- Smoke at least five cigarettes per day and willing to reduce or quit smoking within the next 6 months
- Stable HbA1c ≥7.0% - 10% with no more than a 1% change over the last 3 to 6 months.
- Have not used GLP-1 receptor agonists in the past six months.
- Able to provide informed consent
Who cannot join
- Pregnant or breastfeeding individuals
- 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.
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- 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-up 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 investigator (for example acutely unwell, life expectancy less than 1 year).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Nidhi Agarwal, 613-696-7000, Nagrawal@ottawaheart.ca
Hassan Mir, MD
About this study
Official title: Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled 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.
Read the detailed description
Smoking and diabetes are well-established risk factors for cardiovascular disease (CVD) and leading causes of global morbidity and mortality. Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are primarily known for their role in managing diabetes, where they have demonstrated tremendous benefits in glucose control and weight loss. Approximately 12% of adults in the U.S. have ever taken a GLP-1 RA, with 6% currently using these medications. Beyond their primary focus, emerging evidence shows improved clinical outcomes such as Major Adverse Cardiovascular Events (MACE) and Obstructive Sleep Apnea (OSA). Recent research explores the potential role of GLP-1 RA in nicotine addiction. These medications suppress nicotine-induced dopamine release in the nucleus, which supports the exploration of GLP-1 RA therapies for nicotine dependence. Additionally, GLP-1 RA stimulates insulin secretion and reduces energy intake, addressing the common concern of post-cessation weight gain.
While GLP-1 RA have been extensively studied for their effects on weight management, their impact on smoking cessation has only been investigated in a limited number of trials. High-quality evidence is needed using newer and more commonly used GLP-1 RA to assess their effect on smoking cessation and mitigating post-cessation weight gain. We plan to conduct a definitive RCT but need a pilot study to determine feasibility of recruitment, treatment adherence, attrition, and to provide a preliminary estimate of effect size (for sample size calculation).
Research question - Among individuals living with diabetes who smoke, does the addition of GLP-1 RA to combination NRT result in increased smoking cessation at 6-month follow-up?
- Being tested
- Semaglutide, Nicotine replacement
- Medical subject headings
- Diabetes Mellitus, Type 2, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Nicotine replacementDrug
Nicotine patch plus short-acting NRT gum or lozenge
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Semaglutide + Combination NRT for up to 6 months Receives: Drug: Semaglutide; Drug: Nicotine replacement |
| Control | Active comparator | Combination NRT for up to 6 months Receives: Drug: Nicotine replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Project success
Feasibility will be assessed to provide insights into the potential for a larger trial. Successful completion of this pilot will indicate that a full-scale study is both viable and likely to yield meaningful results. To measure this, the total number of people enrolled will be compared to the total number of people approached to participate.
Measured: 12 months
Secondary outcomes (5)
Smoking status
Participants will be asked if they have quit smoking cigarettesat the 6-month follow-up. This will demonstrate the effectiveness of the pharmacotherapy and GLP-1 products.
Measured: 6 months
Blood glucose score
The A1c test result is reported as a percentage. The score represents the portion of hemoglobin proteins that are holding glucose. The higher the percentage, the higher blood sugar level an individual has. The range of scores are <5.7% to >10%. Less than 5.7% means no diabetes,5.7% to 6.4% signals prediabetes.
6.5% or higher usually indicates Type 2 diabetes. HbA1c will be measured at 6 and 12 months in order to measure glycemic control.
Measured: 6, and 12 months
Height
Height will be measured to look for change over time in both groups. It will be recorded in cm.
Measured: 6, and 12 months
Weight
Height will be measured to look for change over time in both groups. It will be recorded in kgs.
Measured: 6, and 12 months
Waist circumference
Height will be measured to look for change over time in both groups. It will be recorded in cm.
Measured: 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start13 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 open label
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059377
- Sponsor's protocol ID
- HM74061
- Acronym
- GLP1-SC
- Status last verified
- May 2026
- First submitted
- 30 Apr 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07059377
- Acronym / sponsor ID
- GLP1-SC / HM74061
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Smoking and diabetes are well-established risk factors for cardiovascular disease (CVD) and leading causes of global morbidity and mortality. Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are primarily known for their role in managing diabetes, where they have demonstrated tremendous benefits in glucose control and weight loss. Approximately 12% of adults in the U.S. have ever taken a GLP-1 RA, with 6% currently using these medications. Beyond their primary focus, emerging evidence shows improved clinical outcomes such as Major Adverse Cardiovascular Events (MACE) and Obstructive Sleep Apnea (OSA). Recent research explores the potential role of GLP-1 RA in nicotine addiction. These medications suppress nicotine-induced dopamine release in the nucleus, which supports the exploration of GLP-1 RA therapies for nicotine dependence. Additionally, GLP-1 RA stimulates insulin secretion and reduces energy intake, addressing the common concern of post-cessation weight gain.
While GLP-1 RA have been extensively studied for their effects on weight management, their impact on smoking cessation has only been investigated in a limited number of trials. High-quality evidence is needed using newer and more commonly used GLP-1 RA to assess their effect on smoking cessation and mitigating post-cessation weight gain. We plan to conduct a definitive RCT but need a pilot study to determine feasibility of recruitment, treatment adherence, attrition, and to provide a preliminary estimate of effect size (for sample size calculation).
Research question - Among individuals living with diabetes who smoke, does the addition of GLP-1 RA to combination NRT result in increased smoking cessation at 6-month follow-up?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 open label
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Semaglutide, Drug: Nicotine replacementSemaglutide + Combination NRT for up to 6 months |
| Control | Active comparator | Drug: Nicotine replacementCombination NRT for up to 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (18 years or older) with type 2 diabetes
- Currently residing in Ontario
- Smoke at least five cigarettes per day and willing to reduce or quit smoking within the next 6 months
- Stable HbA1c ≥7.0% - 10% with no more than a 1% change over the last 3 to 6 months.
- Have not used GLP-1 receptor agonists in the past six months.
Key exclusion criteria (16 listed)
- Pregnant or breastfeeding individuals
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideStarting 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 | Drug | Intervention |
| Nicotine replacementNicotine patch plus short-acting NRT gum or lozenge | Drug | Control, Intervention |
Primary outcome
Project success
Time frame: 12 months
Feasibility will be assessed to provide insights into the potential for a larger trial. Successful completion of this pilot will indicate that a full-scale study is both viable and likely to yield meaningful results. To measure this, the total number of people enrolled will be compared to the total number of people approached to participate.
5 secondary outcomes
Smoking status
Time frame: 6 months
Blood glucose score
Time frame: 6, and 12 months
Height
Time frame: 6, and 12 months
Weight
Time frame: 6, and 12 months
Waist circumference
Time frame: 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide and Nicotine replacement in people with Diabetes Mellitus, Type 2 and Nicotine Addiction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evyanne Quirouette (613-696-7000 ext. 17596, equirouette@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Project success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.