Semaglutide to help people with type 2 diabetes quit smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Evyanne Quirouette
• Email: equirouette@ottawaheart.ca
• Phone: 613-696-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.