RecruitingPhase 3NCT07059377

Semaglutide for Smoking Cessation in Patients With Diabetes

Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled Trial

Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

100 participants

Start Date

Feb 13, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Tobacco Dependence Nicotine Addiction

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria16

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).

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Interventions

DRUGSemaglutide

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

DRUGNicotine replacement

Nicotine patch plus short-acting NRT gum or lozenge