Clinical trial

Semaglutide for Smoking Cessation in Patients With Diabetes

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07059377

Recruiting nowPhase 3Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus, Type 2, Nicotine Addiction, Tobacco Dependence

Full registry 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).

Treatments and study arms

Semaglutide

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

Drug

Nicotine patch plus short-acting NRT gum or lozenge

Primary outcomes

Project success12 months

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Ottawa Heart Institute🇨🇦 Ottawa, Ontario, Canada

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Nidhi AgarwalContact

Email · Call 613-696-7000

Hassan Mir, MDPrincipal Investigator