LivingGLP1
parallel randomized trial

SKIP

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues - a Randomized, Double-blind, Placebo-controlled Trial

Tobacco useNCT03204396S000115

Design

Randomized
255
Start year
2017
Treatment
12 weeks, follow-up 52 weeks
Countries
Switzerland (1 sites)
Sponsor
University Hospital, Basel, Switzerland (non industry)
Eligibility
age 18 to 75; daily smokers willing to quit; Fagerstroem 5 or more; varenicline accepted

Conduct and analysis

Blinding
double blind
Sequence generation
computer
Allocation concealment
central
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
full analysis
Missing data
missing abstinence counted as smoking

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Dulaglutide 1.5 mg subcutaneous once weekly
Dulaglutide 1.5 mg once weekly
varenicline titrated to 1 mg twice daily plus smoking cessation counseling; lifestyle: not reported127127
A2Placebo
Placebo
varenicline 1 mg twice daily and behavioral counseling; lifestyle: not reported128128

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticDulaglutide 1.5 mg subcutaneous once weekly
A1
Placebo
A2
agemean (years)42.743.2
agesd (years)13.813.1
bmimean (kg/m2)27.127.1
bmisd (kg/m2)5.15.0
femalen8372
femalepercent65.456.3
hba1cmedian (percent)5.35.4
hba1cq1 (percent)5.15.1
hba1cq3 (percent)5.75.6
sbpmean (mmHg)119.5122.2
sbpsd (mmHg)13.614.7
weightmean (kg)79.081.2
weightsd (kg)17.917.9
whiten126121
whitepercent99.294.5

Results

38 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Tobacco abstinence (4 lines; O111)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1responders50 / 127not stated; full analysis; R0014908:Results
24A2responders51 / 128not stated; full analysis; R0014908:Results
52A1responders37 / 127not stated; full analysis; R0014908:Results
52A2responders35 / 128not stated; full analysis; R0014908:Results
Tobacco point prevalence abstinence (20 lines; O111B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
12A1responders80 / 127not stated; full analysis; R0014721:Results
12A1responders98 / 127not stated; full analysis; R0014721:Supplement Results
12A1responders59 / 127not stated; full analysis; R0014721:Results
12A1responders73 / 101not stated; per protocol; R0014721:Supplement Results
12A1responders80 / 127not stated; full analysis; R0014721:Supplement Results
12A1 vs A2rd-1.9-10.7 to 14.4not stated; full analysis; R0014721:Results
12A1 vs A2rd12.30.5 to 24.1not stated; full analysis; R0014721:Supplement Results
12A1 vs A2rd-3.5-9.5 to 16.6not stated; full analysis; R0014721:Results
12A1 vs A2rd-4.4-8.5 to 17.4not stated; per protocol; R0014721:Supplement Results
12A1 vs A2rd-12.0-24.4 to 0.1not stated; full analysis; R0014721:Supplement Results
12A2responders82 / 128not stated; full analysis; R0010911:Abstract
12A2responders83 / 128not stated; full analysis; R0014721:Results
12A2responders83 / 128not stated; full analysis; R0014721:Supplement Results
12A2responders64 / 128not stated; full analysis; R0014721:Results
12A2responders79 / 103not stated; per protocol; R0014721:Supplement Results
12A2responders96 / 128not stated; full analysis; R0014721:Supplement Results
24A1responders54 / 127not stated; full analysis; R0014908:Results
24A2responders52 / 128not stated; full analysis; R0014908:Results
52A1responders41 / 127not stated; full analysis; R0014908:Results
52A2responders41 / 128not stated; full analysis; R0014908:Results
Acute kidney injury (2 lines; O121)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 127not stated; full analysis; R0014721:Supplement Table S4
A2events0 / 128not stated; full analysis; R0014721:Supplement Table S4
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events5 / 127not stated; full analysis; R0014721:Supplement Table S4
A2events4 / 128not stated; full analysis; R0014721:Supplement Table S4
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events10 / 127not stated; full analysis; R0014721:Results
A2events6 / 128not stated; full analysis; R0014721:Results
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events98 / 127not stated; full analysis; R0014721:Supplement Table S4
A2events79 / 128not stated; full analysis; R0014721:Supplement Table S4
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events45 / 127not stated; full analysis; R0014721:Supplement Table S4
A2events24 / 128not stated; full analysis; R0014721:Supplement Table S4
Diarrhea (2 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events39 / 127not stated; full analysis; R0014721:Supplement Table S4
A2events49 / 128not stated; full analysis; R0014721:Supplement Table S4
Constipation (2 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events49 / 127not stated; full analysis; R0014721:Supplement Table S4
A2events35 / 128not stated; full analysis; R0014721:Supplement Table S4