Semaglutide to help people with type 2 diabetes quit smoking
Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled Trial
This pilot will test whether adding semaglutide to combination nicotine replacement helps adults with type 2 diabetes quit smoking and limits post-quit weight gain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT07059377 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial will give adults with type 2 diabetes who smoke combination nicotine replacement therapy with or without semaglutide to determine feasibility and get preliminary signals of effectiveness. Recruitment will occur in Ontario and participants must have stable glycemic control and not have used GLP-1 receptor agonists recently. The primary outcomes are feasibility measures such as recruitment rate, treatment adherence, and attrition; secondary outcomes include biochemically confirmed smoking abstinence, weight change, and glycemic measurements. Results will be used to plan a larger definitive RCT.
Who should consider this trial
Good fit: Adults (18+) in Ontario with type 2 diabetes who smoke at least five cigarettes per day, have stable HbA1c of roughly 7–10%, and have not used a GLP-1 receptor agonist in the past six months.
Not a fit: People who are pregnant or breastfeeding, have contraindications to GLP-1 RAs or nicotine replacement, are current daily users of GLP-1 RAs or certain smoking medications, or have excluded thyroid/endocrine conditions would not be eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding semaglutide could make quitting easier for people with type 2 diabetes while reducing the typical weight gain after stopping smoking.
How similar studies have performed: Preclinical and a few small clinical studies suggest GLP-1 receptor agonists can reduce nicotine reward and may help with cessation, but high-quality evidence using semaglutide for smoking cessation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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).
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Evyanne Quirouette
- Email: equirouette@ottawaheart.ca
- Phone: 613-696-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.