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Search / Trial NCT07059377

Semaglutide for Smoking Cessation in Patients With Diabetes

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Jul 7, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medicine called semaglutide can help people with type 2 diabetes quit smoking when used alongside standard nicotine replacement treatments like patches or gum. The study aims to see if it’s possible to run a larger trial to test how well semaglutide supports smoking cessation in this group.

Adults with type 2 diabetes who live in Ontario and smoke at least five cigarettes a day may be eligible to join, especially if their blood sugar levels are fairly stable. Participants should be ready to try to reduce or quit smoking within the next six months and have not used similar diabetes medicines recently. People who are pregnant, have certain medical conditions, or are already using specific smoking or diabetes treatments won’t be able to take part. Those who join can expect to receive either semaglutide or a placebo along with nicotine replacement therapy and will be followed over time to see how well the treatment helps them quit smoking. The study is not yet open for recruitment.

Gender

ALL

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).

About Ottawa Heart Institute Research Corporation

The Ottawa Heart Institute Research Corporation is a leading clinical research organization dedicated to advancing cardiovascular medicine through innovative research and clinical trials. Affiliated with the renowned University of Ottawa Heart Institute, the corporation focuses on conducting high-quality, ethically-driven studies that aim to improve patient outcomes and enhance understanding of heart-related diseases. With a commitment to collaboration and excellence, the organization engages multidisciplinary teams of researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective therapies and interventions for cardiovascular health.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported