Semaglutide for Smoking Cessation in Patients With Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide
DrugStarting 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
DrugNicotine patch plus short-acting NRT gum or lozenge
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov