NCT04231838.

Study name	A randomized 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 Short title: Metabolic syndrome in diabetic smokers using cigarettes & combustion‐free nicotine delivery systems (DIASMOKE)
Methods	RCT Setting: Italy
Participants	576 participants 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 32.0 kg/m2, inclusive 2.2. body weight exceeding 50 kg (men) or 40 kg women 2.3 6.5 < HbA1C < 10 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 5 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 Arm 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: Women who are pregnant or breastfeeding. This will be confirmed at screening and at visit 1. Any woman who becomes pregnant during this study will be withdrawn People with a history of recent acute decompensation of their disease requiring treatment within 4 weeks prior to visit 1 People who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the investigator People 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 People who have, or who have a history of, any clinically‐significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematological or other major disorder that, in the opinion of the investigator or their appropriately qualified designee, would jeopardize the safety of the person or impact on the validity of the study results People 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 into 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 person who decides to quit smoking will be directed to local stop smoking services.
Interventions	Arm A: tobacco cigarettes (continuing smoking their own tobacco cigarette brand) Arm B: switching to using combustion‐free nicotine delivery systems (C‐F NDS)
Outcomes	Time frame: 3 months, 6 months, 1 year and 2 years Change in metabolic syndrome prevalence Change in plasma glucose Change in triglycerides Change in high‐density lipoprotein (HDL) Change in waist circumference
Starting date	Estimated start date: 17 September 2020. Estimated primary completion September 2021. Estimated study completion March 2025
Contact information	Daniela Saitta, PhD, daniela.saitta@eclatrbc.it Riccardo Polosa, PhD, polosa@unict.it
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