parallel randomized trial

NCT01753362

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES

Type 1 diabetes NCT01753362S001628

Design

Randomized: 85
Start year: 2012
Treatment: 26 weeks, follow-up 26 weeks
Countries: United States
Sponsor: University at Buffalo (not reported)
Eligibility: type 1 diabetes 1 year or more on insulin; undetectable C-peptide; overweight or obese

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	insulin therapy; lifestyle: not reported		26
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	insulin therapy; lifestyle: not reported		40

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Liraglutide 1.8 mg subcutaneous once daily A2	Whole trial ALL
age	mean (years)			46.1
asian	n	0	0
black	n	3	2
bmi	mean (kg/m2)			31.2
female	n	16	26
hba1c	mean (percent)			7.85
other race american indian alaska native	n	0	0
other race multiple	n	0	0
other race native hawaiian pacific islander	n	0	0
white	n	23	38

Analyses this trial contributes to

Results

9 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A2 vs A1	md	-0.34 percent			not stated; completers; R0024715:Abstract
26	A1	final	7.64 percent	0.84	26	not stated; completers; registry:outcomes
26	A2	change	-0.41 percent		37	not stated; completers; R0024715:Abstract
26	A2	final	7.60 percent	0.98	40	not stated; completers; registry:outcomes
26	A2 vs A1	md	-0.29 percent			not stated; completers; R0024715:Abstract

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; safety; registry:adverse_events
	A2	events				0 / 40	not stated; safety; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; safety; registry:adverse_events
	A2	events				0 / 40	not stated; safety; registry:adverse_events