Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: (DIASMOKE)

NCT01387425 | Completed

• 1 other identifier: 2009-017599-26
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Objectives This protocol is intended to provide information regarding the efficacy and safety of the nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking cessation in diabetic subjects who smoke. Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at the end of the study will also be examined Study Population The study will enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design The study is a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking cessation. The duration of active treatment will be 12 weeks and subjects will be followed in the nontreatment phase for an additional 12 weeks. This clinical study has an optional research component to prolong the follow up in the nontreatment phase for a full year. Predictors of abstinence at the end of the study will also be examined Study Endpoints Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate since last visit. Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on the study visit at week 24 Co-primary endpoint: Success rates at week 12 in the varenicline vs placebo group. Success rates will be defined as Continuous Quit Rate for Weeks 8 to 12 of treatment. Subjects will be classified as responders if they are able to maintain complete abstinence from cigarette smoking in each of the last four study visits (week 9, week 10, week 11, and week 12) with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last four study visits (week 9, week 10, week 11, and week 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Secondary Endpoint: Success rates at week 52 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate throughout the last three visits (week 24, week 36, and week 44). Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last three study visits (week 24, week 36 and week 44) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Additional Measures: Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at week 24 and at week 52 will also be examined

Conditions

Smoking Cessation; Diabetes

Keywords

Smoking cessation of diabetic smoker

Outcome Measures

Primary Outcomes (1)

• Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm.

  Adverse events observed or reported will be recorded. Assessments as to seriousness, severity, and the relationship to treatment and other causes will be made. Physical examination will be performed at the screening visit and at Wk 12. Blood pressure and heart rate will be measured at all visits. BMI and waist will be calculated at the screening visit and at Week 13, 24, 52. Blood chemistry, complete blood count, and urinalysis will be completed at screening, baseline, Week 2 and 12.

  week 24

Secondary Outcomes (5)

• Success rates at week 52 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate (CQR) throughout the last three visits (week 24, week 36, and week 44).

  week 52

• "Number of Participants with Adverse Events"

  24-weeks

• "Change from Baseline in Systolic Blood Pressure"

  24- and 52-weeks

• "Change from Baseline in HbA1c"

  24- and 52-weeks

• "Change from Baseline in BMI"

  24- and 52-weeks

Study Arms (2)

varenicline

ACTIVE COMPARATOR

varenicline 1 mg BID. The duration of active treatment will be 12 weeks.

Drug: varenicline

control group

PLACEBO COMPARATOR

Drug: placebo tablet is made of lactose

Interventions

varenicline DRUG

varenicline at a dose of 1 mg twice a day for 12 week

varenicline

placebo tablet is made of lactose DRUG

placebo at a dose of 1 mg twice for 12 week

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients (≤ 75 years of age) who are regular smokers (≥10 cigs/day during the past year, with no period of abstinence greater than three months in the past year) and willing to quit.
• Females of non childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception.
• Subjects must be able to be outpatients and be assessed in a clinic setting.
• Participating subjects must be able to provide written informed consent.

You may not qualify if:

• Subjects currently or within the past 12 months requiring treatment for depression. Subjects with a past or present history of panic disorder, psychosis, or bipolar disorder;
• Subjects with a current or recent (within the past 12 months) history of alcoholism;
• Subjects with a requirement to use other medications during the study that might interfere with the evaluation of the study drug (e.g., nicotine replacement therapy);
• Subjects with a body mass index (BMI) less than 15 or greater than 38, wearing indoor clothing without shoes and determined using the Body Mass Index (BMI);
• Subjects with a history of clinically significant cardiovascular disease. In addition, subjects with uncontrolled hypertension or a screening or baseline systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg will be excluded.

Sponsors & Collaborators

• Universita degli Studi di Catania: lead

Study Sites (2)

Centro per la Prevenzione e Cura del Tabagimso

Catania, Italy, 95124, Italy

Location

Centro per la Prevenzione eCura del Tabagimso

Catania, Italy, 95124, Italy

Location

Related Publications (3)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

• Russo C, Walicka M, Caponnetto P, Cibella F, Maglia M, Alamo A, Campagna D, Frittitta L, Di Mauro M, Caci G, Krysinski A, Franek E, Polosa R. Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2217709. doi: 10.1001/jamanetworkopen.2022.17709.

  PMID: 35727580 DERIVED

• Russo C, Caponnetto P, Cibella F, Maglia M, Alamo A, Campagna D, Frittitta L, Di Mauro M, Leotta C, Mondati E, Krysinski A, Franek E, Polosa R. A double blind randomized controlled trial investigating efficacy and safety of varenicline for smoking cessation in patients with type 2 diabetes: study protocol. Intern Emerg Med. 2021 Oct;16(7):1823-1839. doi: 10.1007/s11739-021-02684-1. Epub 2021 Mar 18.

  PMID: 33735416 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Diabetes Mellitus

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: July 4, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

IT (2)