parallel randomized trial

S002957

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

Type 2 diabetes (adults)S002957

Design

Randomized: 33
Start year: 2016
Treatment: 12 weeks, follow-up 12 weeks
Countries: Japan (6 sites)
Sponsor: (not reported)
Eligibility: age 20 or more; HbA1c 6.0 to <9.0%; liraglutide 0.9 mg for over 3 months

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	liraglutide Lira group	prior oral agents and insulin continued; lifestyle: standard	16	15
A2	Dulaglutide 0.75 mg subcutaneous once weekly Dula group	prior oral agents and insulin continued; lifestyle: standard	17	16

Baseline characteristics

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

Characteristic	Statistic	Lira group A1	Dulaglutide 0.75 mg subcutaneous once weekly A2
age	mean (years)	61.2	62.7
age	sd (years)	12.8	11.2
diabetes duration	mean (years)	18.5	18.6
diabetes duration	sd (years)	9.8	10.6
female	n	8	10
hba1c	mean (percent)	7.4	7.7
hba1c	sd (percent)	0.5	0.8
insulin use	percent	50.0	58.8
metformin use	percent	68.8	88.2
other alpha glucosidase inhibitor use	percent	25.0	17.6
other glinide use	percent	18.8	11.8
other sulfonylurea use	percent	18.8	47.1
other thiazolidinedione use	percent	12.5	0.0
sglt2i use	percent	37.5	17.6
weight	mean (kg)	70.7	71.2
weight	sd (kg)	11.9	18.1

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	0.05 percent	0.41			not stated; other; R0007926:Table 3
12	A2	change	0.00 percent	0.68			not stated; other; R0007926:Table 3

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	kg				not stated; other; R0007926:Table 3
12	A2	change	kg				not stated; other; R0007926:Table 3

Health related quality of life total score (any instrument) (4 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-3.7 points	6.9	15	not stated; completers; R0007926:Table 2
12	A1	change	0.1 points	4.7	15	not stated; completers; R0007926:Table 2
12	A2	change	8.9 points	15.1	16	not stated; completers; R0007926:Table 2
12	A2	change	4.9 points	5.2	16	not stated; completers; R0007926:Table 2