Semaglutide for Smoking Cessation in Patients With Diabetes

NCT07059377 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HM74061
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2; Nicotine Addiction; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

• Smoking status

  6 months

• Blood glucose score

  6, and 12 months

• Height

  6, and 12 months

• Weight

  6, and 12 months

• Waist circumference

  6, and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Semaglutide + Combination NRT for up to 6 months

Drug: Semaglutide; Drug: Nicotine replacement

Control

ACTIVE COMPARATOR

Combination NRT for up to 6 months

Drug: Nicotine replacement

Interventions

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

Intervention

Nicotine replacement DRUG

Nicotine patch plus short-acting NRT gum or lozenge

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Tobacco Use Disorder

Interventions

semaglutide; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Evyanne Quirouette

CONTACT

613-696-7000; equirouette@ottawaheart.ca

Nidhi Agrawal

CONTACT

613-696-7000; NAgrawal@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 open label

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: July 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share