Impact of Combustion-Free Nicotine on Cardiovascular Risk in Diabetic Smokers

A Randomised Controlled International Multicentre Study Evaluating Changes in Metabolic Syndrome in Smokers With Type 2 Diabetes Mellitus After Switching From Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems: DIASMOKE Study

This study is testing if switching from regular cigarettes to combustion-free nicotine products can lower heart health risks for people with Type 2 Diabetes who smoke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 576 (estimated)
• Ages: 23 Years and up
• Sex: All
• Sponsor: Eclat Srl. (Academic / other)
• Locations: 1 site (Chertsey, Surrey)
• Trial ID: NCT04231838 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combustion-free nicotine delivery systems (C-F NDS) on cardiovascular risk factors in patients with Type 2 Diabetes Mellitus (T2DM) who smoke. It is a multicenter, randomized controlled trial that will compare two groups: one that continues smoking traditional cigarettes and another that switches to C-F NDS. Over a two-year period, participants will undergo regular assessments to evaluate changes in cardiovascular health and other functional parameters. The study aims to provide data on whether switching to C-F NDS can reduce health risks associated with smoking in this population.

Who should consider this trial

Good fit: Ideal candidates are adult smokers aged over 23 with Type 2 Diabetes Mellitus who smoke at least 10 cigarettes per day.

Not a fit: Patients who do not smoke or those who are not diagnosed with Type 2 Diabetes Mellitus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular health outcomes for diabetic smokers by providing a safer alternative to traditional smoking.

How similar studies have performed: While there is limited data on C-F NDS specifically for diabetic smokers, similar studies have shown potential benefits of switching from traditional smoking to less harmful alternatives.

Eligibility criteria

Inclusion Criteria:

Participants will be required to satisfy all of the following criteria at the screening visit, unless otherwise stated:

• Participants will be: 1.1. over 23 years of age

• T2DM Patients will have: 2.1. body mass index (BMI) between 17.6 and 34.5 kg/m2, inclusive 2.2. body weight exceeding 50 kg (males) or 40 kg (females) 2.3 6.0\<HbA1C\<12 3.2. completion of proforma (CRF) 3.3. lab assessment as outlined in the CRF

* Participants will be willing to refrain from eating/drinking prior to screening and Check-in at each study visit.
* Participants will be regular smokers of at least 10 cigarettes/day (max 30 cigarette/day)
* Participants will have smoked for at least five consecutive years prior to screening.
* Participants must have a saliva cotinine level \> 10 ng/mL or an exhaled breath CO (eCO) level \> 7 ppm at screening.
* Participants in Arm A who continue to smoke will be willing to use their own brand/type cigarettes.
* Participants in Arms B will be willing to use the study products (THP product or e-cigarette) provided to them during the study.

Exclusion Criteria:

Participants will be excluded at the screening visit based on the following criteria:

* Female participants who are pregnant or breastfeeding. This will be confirmed at screening and at visit 1. Any female subject who becomes pregnant during this study will be withdrawn.
* Participants with a history of recent acute decompensation of their disease requiring treatment within 4 weeks prior to visit 1.
* Participants who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the investigator.
* Participants who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first product use.
* Participants who have, or who have a history of, any clinically-significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the investigator or their appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results.
* Participants who regularly use any nicotine (e.g. e-cigarettes, NRT) or tobacco product (e.g. HTPs, oral smokeless) other than their own cigarettes within 14 days of screening.

At screening and prior to enrolment, all patients will be offered a locally available free smoking cessation program as per local guidelines. Those who express the intention of booking for the cessation program together with those who, at screening, are planning to quit smoking in the next 6 months, will not be recruited in the study. Patients taking part in the study will be informed that they are free to quit smoking and withdraw from the study at any time. Any subject who decides to quit smoking will be directed to local stop smoking services.

Withdrawal Criteria:

Patients may be withdrawn from the study prematurely for the following reasons:

1. subject experiences a severe adverse event (SAE). The appropriate SAE electronic Case Report Form (eCRF) page must be completed.
2. If any deviations occur during the conduct of the study, which cannot be corrected. All protocol deviations will be fully documented and considered for their effect on study objectives. Deviations that could lead to subject discontinuation from the study include:

   * deviations which could affect subject's safety (e.g. illness requiring treatment\[s\]) which in the clinical judgement of the investigator might invalidate the study by interfering with the allocated test product or the willingness of the subject to comply with the study activities.
   * deviations involving the use of any nicotine/tobacco products other than the intended conventional cigarettes (in Arm A) or (in Arm B).
3. If the subject is uncooperative, including non-attendance. In these cases, efforts should have been made by the investigator to ascertain the reason and to ensure the subject's attendance as soon as possible.
4. Subject's personal request: the subject could decide, at any moment of the study, to stop his/her participation.
5. Female participant becoming pregnant.

Where this trial is running

Chertsey, Surrey

• Ashford and St Peters NHS Foundation Trust — Chertsey, Surrey, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Pankaj Sharma, PhD — Ashford and St Peter's Hospitals NHS Foundation Trust
• Study coordinator: Daniela Saitta, PhD

Conditions Cardiovascular Risk Factor; Diabetes Mellitus, Type 2; e-cigarettes; Combustion-Free Nicotine Delivery Systems; Tobacco Cigarettes; DIASMOKE 2.0; Metabolic syndrome