Semaglutide for Smoking Cessation in Patients With Diabetes
Recruiting · NCT07059377 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Heart Institute Research Corporation
View the official record on ClinicalTrials.gov →Interventions studied
Nicotine replacementSemaglutide
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- University of Ottawa Heart Institute - Ottawa, Ontario, Canada