Actively Recruiting
Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled Trial
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-11
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of semaglutide combined with nicotine replacement therapy (NRT) to help people with type 2 diabetes quit smoking. This pilot randomized controlled trial aims to assess the feasibility of a larger study by examining recruitment, treatment adherence, and early effects on smoking cessation and weight management. The study focuses on diabetes patients who smoke, as both smoking and diabetes increase the risk of cardiovascular disease. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), is known for managing diabetes and weight, and is being studied here for its potential to reduce nicotine addiction and post-cessation weight gain. Participants will be randomly assigned to one of two groups: one will receive semaglutide along with combination NRT (nicotine patches plus gum or lozenges) for up to 6 months, while the other will receive only combination NRT for up to 6 months. Semaglutide will start at 0.25 mg once weekly for 4 weeks, then increase to 0.5 mg weekly, with possible titration up to 2 mg weekly if more blood sugar control is needed. Both groups will be monitored during the treatment period to compare how well semaglutide supports smoking cessation when added to NRT. During the study, participants will have their smoking status, blood glucose, height, weight, and waist circumference measured at 6 and 12 months. The main goal is to see if the project is successful after 12 months, including recruitment and treatment adherence. Safety and health outcomes will be tracked throughout, with follow-up visits to assess changes and support participants. Total participation will last over a year, allowing researchers to evaluate the long-term effects of semaglutide combined with NRT on quitting smoking in people with diabetes.
CONDITIONS
Brief Title
Semaglutide for Smoking Cessation in Patients With Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 5.0% - 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
You will not qualify if you...
- Pregnant or breastfeeding individuals
- Contraindication to nicotine replacement therapy or GLP-1 receptor agonists
- Current daily use of nicotine replacement therapy or GLP-1 receptor agonists
- Use of bupropion, cytisine, or 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
- 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 due to mental illness, cognitive impairment, or language barriers
- Other conditions that may interfere with participation or outcomes, including life expectancy less than 1 year, as determined by the study investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 26 weeks
Participants receive Semaglutide once weekly and combination nicotine replacement therapy for smoking cessation for up to 26 weeks.
Weekly visits for medication administration and monitoring
Duration - Up to 6 months after treatment
Participants are followed for smoking status, blood glucose, weight, and waist circumference assessments after treatment ends.
Visits at 6 months and 12 months after starting treatment
Trial Site Locations
Total: 1 location
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
Research Team
E
Evyanne Quirouette
N
Nidhi Agrawal
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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