A Phase 3 interventional study of Semaglutide and Nicotine replacement in Diabetes Mellitus, Type 2, Nicotine Addiction and Tobacco Dependence, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 3, Interventional, and Treatment
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.
Smoking and diabetes are well-established risk factors for cardiovascular disease (CVD) and leading causes of global morbidity and mortality. Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are primarily known for their role in managing diabetes, where they have demonstrated tremendous benefits in glucose control and weight loss. Approximately 12% of adults in the U.S. have ever taken a GLP-1 RA, with 6% currently using these medications. Beyond their primary focus, emerging evidence shows improved clinical outcomes such as Major Adverse Cardiovascular Events (MACE) and Obstructive Sleep Apnea (OSA). Recent research explores the potential role of GLP-1 RA in nicotine addiction. These medications suppress nicotine-induced dopamine release in the nucleus, which supports the exploration of GLP-1 RA therapies for nicotine dependence. Additionally, GLP-1 RA stimulates insulin secretion and reduces energy intake, addressing the common concern of post-cessation weight gain.
While GLP-1 RA have been extensively studied for their effects on weight management, their impact on smoking cessation has only been investigated in a limited number of trials. High-quality evidence is needed using newer and more commonly used GLP-1 RA to assess their effect on smoking cessation and mitigating post-cessation weight gain. We plan to conduct a definitive RCT but need a pilot study to determine feasibility of recruitment, treatment adherence, attrition, and to provide a preliminary estimate of effect size (for sample size calculation).
Research question - Among individuals living with diabetes who smoke, does the addition of GLP-1 RA to combination NRT result in increased smoking cessation at 6-month follow-up?
Exclusion Criteria:
Semaglutide + Combination NRT for up to 6 months
Drug: Semaglutide · Drug: Nicotine replacement
Combination NRT for up to 6 months
Drug: Nicotine replacement
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
Nicotine patch plus short-acting NRT gum or lozenge
Project success
Feasibility will be assessed to provide insights into the potential for a larger trial. Successful completion of this pilot will indicate that a full-scale study is both viable and likely to yield meaningful results. To measure this, the total number of people enrolled will be compared to the total number of people approached to participate.
Time frame: 12 months
Smoking status
Participants will be asked if they have quit smoking cigarettesat the 6-month follow-up. This will demonstrate the effectiveness of the pharmacotherapy and GLP-1 products.
Time frame: 6 months
Blood glucose score
The A1c test result is reported as a percentage. The score represents the portion of hemoglobin proteins that are holding glucose. The higher the percentage, the higher blood sugar level an individual has. The range of scores are \<5.7% to \>10%. Less than 5.7% means no diabetes,5.7% to 6.4% signals prediabetes. 6.5% or higher usually indicates Type 2 diabetes. HbA1c will be measured at 6 and 12 months in order to measure glycemic control.
Time frame: 6, and 12 months
Height
Height will be measured to look for change over time in both groups. It will be recorded in cm.
Time frame: 6, and 12 months
Weight
Height will be measured to look for change over time in both groups. It will be recorded in kgs.
Time frame: 6, and 12 months
Waist circumference
Height will be measured to look for change over time in both groups. It will be recorded in cm.
Time frame: 6, and 12 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ottawa Heart Institute Research Corporation