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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Universita degli Studi di Catania
Sponsor:
Information provided by (Responsible Party):
Riccardo Polosa, Universita degli Studi di Catania
ClinicalTrials.gov Identifier:
NCT01387425
First received: June 13, 2011
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Smoking Cessation
Diabetes
Drug: varenicline
Drug: placebo tablet is made of lactose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: A Double-Blind, Placebo-Controlled, Randomized, Trial

Resource links provided by NLM:


Further study details as provided by Universita degli Studi di Catania:

Primary Outcome Measures:
  • 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. [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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). [ Time Frame: week 52 ] [ Designated as safety issue: No ]
    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 (NUI) 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.

  • "Number of Participants with Adverse Events" [ Time Frame: 24-weeks ] [ Designated as safety issue: Yes ]
    Express the percentage of participants with Adverse Events in the active and in the placebo group.

  • "Change from Baseline in Systolic Blood Pressure" [ Time Frame: 24- and 52-weeks ] [ Designated as safety issue: No ]
    This measures the % change from baseline. An improvement in systolic blood pressure is anticipated.

  • "Change from Baseline in HbA1c" [ Time Frame: 24- and 52-weeks ] [ Designated as safety issue: No ]
    This measures the % change from baseline. An improvement in HbA1c is anticipated

  • "Change from Baseline in BMI" [ Time Frame: 24- and 52-weeks ] [ Designated as safety issue: No ]
    This measures the % change from baseline. An slight increase in BMI is expected in the first few months after cessation.


Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline
varenicline 1 mg BID. The duration of active treatment will be 12 weeks.
Drug: varenicline
varenicline at a dose of 1 mg twice a day for 12 week
Placebo Comparator: control group Drug: placebo tablet is made of lactose
placebo at a dose of 1 mg twice for 12 week

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects must be able to be outpatients and be assessed in a clinic setting.
  4. Participating subjects must be able to provide written informed consent.

Exclusion Criteria:

  1. 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;
  2. Subjects with a current or recent (within the past 12 months) history of alcoholism;
  3. 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);
  4. 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);
  5. Subjects with evidence or history of clinically significant allergic (except for seasonal allergies at time of dosing), endocrine, gastrointestinal, hematological, hepatic, neurologic, pulmonary, or renal disease or a history of cancer (excluding treated basal cell carcinoma and squamous cell carcinoma). Exceptions to this exclusion may include subjects with a history of mild chronic obstructive pulmonary disease, and stable thyroid disease.
  6. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387425

Contacts
Contact: Riccardo Polosa, MD, Phd 0039 0957435703 polosa@unict.it

Locations
Italy
Centro per la Prevenzione e Cura del Tabagimso Recruiting
Catania, Italy, 95124
Contact: Riccardo Polosa, MD, Phd    0039 0957435703    polosa@unict.it   
Principal Investigator: Riccardo Polosa, MD, Phd         
Sub-Investigator: Pasquale Caponnetto, MD, Phd         
Centro per la Prevenzione eCura del Tabagimso Recruiting
Catania, Italy, 95124
Contact: Riccardo Polosa, MD, Phd    0039 0957435703    polosa@unict.it   
Sponsors and Collaborators
Universita degli Studi di Catania
  More Information

No publications provided

Responsible Party: Riccardo Polosa, Professor of Internal Medicine, Universita degli Studi di Catania
ClinicalTrials.gov Identifier: NCT01387425     History of Changes
Other Study ID Numbers: 2009-017599-26
Study First Received: June 13, 2011
Last Updated: April 28, 2014
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Universita degli Studi di Catania:
Smoking cessation of diabetic smoker

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014