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Semaglutide for Smoking Cessation in Patients With Diabetes

RecruitingPhase 3

Sponsor: Ottawa Heart Institute Research Corporation

Conditions: Diabetes Mellitus, Type 2, Nicotine Addiction, Tobacco Dependence

Interventions: Semaglutide, Nicotine replacement

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).

Locations (1)

Ottawa, Ontario, Canada