A Phase 3 interventional study of Semaglutide and Nicotine replacement in Diabetes Mellitus, Type 2, Nicotine Addiction and Tobacco Dependence, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 3, Interventional, and Treatment
Among 163 studies testing semaglutide in Diabetes Mellitus, Type 2 — 35 open to participants now, 45 under way, 9 of them phase 3. Semaglutide · Diabetes Mellitus, Type 2.
Among the 163 studies testing semaglutide in Diabetes Mellitus, Type 2, this one is the 88th largest by planned enrollment, is one of 8 that started in 2026, is one of 57 in phase 3, reaches primary completion later than 19 of the 44 other live ones, and was the 146th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →35 of the 163 studies testing semaglutide in Diabetes Mellitus, Type 2 are open now, in 12 countries. Recruiting first, the newest first:
Mapi Pharma Ltd. · Sites in Israel
Ages 18–64
Emory University · Sites in United States
Ages 65+ · Women only
Daewoong Pharmaceutical Co. LTD. · Sites in Korea, Republic of
Ages 19–64 · Healthy volunteers
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–70
Hospital Universitario Dr. Jose E. Gonzalez · Sites in Mexico
Ages 18+
By country, each count listing its studies:
Semaglutide: first FDA approval 2017 (OZEMPIC), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, semaglutide is the treatment under test here. Read study by study →
163 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 14 · Phase 3 58 · Phase 4 40
First in 2007; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 104 across the 163 interventional studies. Of the 109 that completed or were terminated, 54 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
100 of 163 have an industry lead sponsor. The 10 most frequent:
Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
Ottawa Heart Institute Research Corporation has 5 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
14 of the studies testing semaglutide in Diabetes Mellitus, Type 2 that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07059377Phase 3Ottawa Heart Institute Research CorporationSemaglutide for Smoking Cessation in Patients With Diabetes | 2026-12 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT06715514Lia BallyMenopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Overweight/Obesity and Impaired Glucose Homeostasis | 2026-12-17 |
| NCT06461377The First Affiliated Hospital with Nanjing Medical UniversityThe Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy | 2026-12-31 |
Add all 14 to your calendar (.ics) → With an account.
Among the 163 studies testing semaglutide in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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?
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Semaglutide + Combination NRT for up to 6 months
Drug: Semaglutide · Drug: Nicotine replacement
Combination NRT for up to 6 months
Drug: Nicotine replacement
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 patch plus short-acting NRT gum or lozenge
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 months
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 months
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 months
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 months
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 months
Waist circumference
Height will be measured to look for change over time in both groups. It will be recorded in cm.
Time frame: 6, and 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 87 non-industry phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 10 months is below that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Semaglutide
Ottawa Heart Institute Research Corporation →