Semaglutide for Smoking Cessation in Patients With Diabetes

NCT ID: NCT07059377

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-07-31

Brief 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.

Detailed Description

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?

Conditions

Diabetes Mellitus, Type 2; Nicotine Addiction; Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Semaglutide + Combination NRT for up to 6 months

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

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 replacement

Intervention Type: DRUG

Nicotine patch plus short-acting NRT gum or lozenge

Control

Combination NRT for up to 6 months

Group Type: ACTIVE_COMPARATOR

Nicotine replacement

Intervention Type: DRUG

Nicotine patch plus short-acting NRT gum or lozenge

Interventions

Semaglutide

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

Intervention Type: DRUG

Nicotine replacement

Nicotine patch plus short-acting NRT gum or lozenge

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Evyanne Quirouette

Role: CONTACT

equirouette@ottawaheart.ca

613-696-7000 ext. 17596

Nidhi Agrawal

Role: CONTACT

NAgrawal@ottawaheart.ca

613-696-7000 ext. 14355

Other Identifiers

HM74061

Identifier Type: -

Identifier Source: org_study_id