parallel randomized trial

S003006

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)S003006

Design

Randomized: 60
Start year: 2013
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (6 sites)
Sponsor: (non industry)
Eligibility: Japanese adults 20 or older; HbA1c 7.0 to below 10 on DPP-4 inhibitor based oral therapy

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin glargine Insulin glargine added to sitagliptin	sitagliptin 50 mg plus other oral agents (glimepiride, metformin and others); lifestyle: not reported	30	26
A2	Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg replacing sitagliptin	oral agents other than sitagliptin (glimepiride, metformin and others); lifestyle: not reported	30	29

Baseline characteristics

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

Characteristic	Statistic	Insulin glargine A1	Liraglutide 0.9 mg injection once daily A2
age	mean (years)	60.6	63.9
age	sd (years)	13.2	10.4
bmi	mean (kg/m2)	26.4	26.6
bmi	sd (kg/m2)	5.1	4.0
diabetes duration	mean (years)	13.0	11.9
diabetes duration	sd (years)	7.5	6.1
egfr	mean (mL/min/1.73 m2)	79.9	73.2
egfr	sd (mL/min/1.73 m2)	15.4	14.9
female	n	10	11
hba1c	mean (percent)	8.3	8.2
hba1c	sd (percent)	0.8	0.5
metformin use	n	17	14
metformin use	percent	65.4	48.3
other agi use	n	3	3
other agi use	percent	11.5	10.3
other glinide use	n	0	2
other glinide use	percent	0.0	0.7
other sulfonylurea use	n	17	22
other sulfonylurea use	percent	65.4	75.9
other tzd use	n	6	2
other tzd use	percent	23.1	0.7
waist	mean (cm)	90.4	93.0
waist	sd (cm)	10.3	11.2
weight	mean (kg)	71.5	69.8
weight	sd (kg)	18.7	14.3

Analyses this trial contributes to

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
24	A1	change	-1.0 percent	0.9		26	not stated; completers; R0010916:Results
24	A2	change	-0.6 percent	0.8		29	not stated; completers; R0010916:Results

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	0.5 kg	2.6	26	not stated; completers; R0010916:Results
24	A1	final	72.0 kg	20.3	26	not stated; completers; R0010916:Table 3
24	A2	change	-2.2 kg	2.0	29	not stated; completers; R0010916:Results
24	A2	final	67.6 kg	14.0	29	not stated; completers; R0010916:Table 3

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	42.3			26	not stated; completers; R0010916:Results
24	A2	responders	24.1			29	not stated; completers; R0010916:Results