parallel randomized trial

S003043

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)Chronic kidney disease with diabetesS003043

Design

Randomized: 139
Start year: 2010
Treatment: 208.56 weeks, follow-up 208.56 weeks
Countries: Japan (1 sites)
Sponsor: (not reported)
Eligibility: T2D with eGFR 30 to 60; suboptimal glycemic control; C-peptide 2.0 or more; insulin up to 20 U

Conduct and analysis

Blinding: not reported
Sequence generation: not reported
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	liraglutide Liraglutide 0.9 mg daily	prior antidiabetic agents replaced or kept (insulin, alpha glucosidase inhibitor, glinide in some); lifestyle: not reported	45	32
A2	Sitagliptin Sitagliptin 50 mg daily	prior antidiabetic agents replaced or kept (insulin, alpha glucosidase inhibitor, glinide in some); lifestyle: not reported	49	34
A3	Linagliptin Linagliptin 5 mg daily	prior antidiabetic agents replaced or kept (insulin, alpha glucosidase inhibitor, glinide in some); lifestyle: not reported	45	32

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 0.9 mg daily A1	Sitagliptin A2	Linagliptin A3
age	mean (years)	70.5	69.9	69.0
age	sd (years)	5.7	8.5	7.7
bmi	mean (kg/m2)	23.5	24.2	23.8
bmi	sd (kg/m2)	3.5	3.8	4.8
diabetes duration	mean (years)	9.2	8.8	8.3
diabetes duration	sd (years)	7.0	8.3	0.4
egfr	mean (mL/min/1.73 m2)	40.2	46.1	45.2
egfr	sd (mL/min/1.73 m2)	11.6	12.8	14.2
hba1c	mean (percent)	6.75	6.72	6.71
hba1c	sd (percent)	0.62	0.72	0.75
lvef	mean (percent)	66.3	68.9	66.0
lvef	sd (percent)	10.2	7.2	7.2
other background: alpha glucosidase inhibitor only	n	3	4	4
other background: alpha glucosidase inhibitor only	percent	9.4	11.8	12.5
other background: glinide only	n	3	3	2
other background: glinide only	percent	9.4	8.8	6.3
other background: insulin only	n	3	3	3
other background: insulin only	percent	9.4	8.8	9.4
other background: none	n	23	24	21
other background: none	percent	71.9	70.6	65.6
sbp	mean (mmHg)	141.1	135.8	133.1
sbp	sd (mmHg)	9.7	14.9	16.7
uacr	mean (mg/g)	380.0	300.1	289.7
uacr	se (mg/g)	62.4	47.0	44.6

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52.14	A1	final	6.40 percent	0.56	32	not stated; completers; R0019822:Table 2
52.14	A2	final	6.48 percent	0.66	34	not stated; completers; R0019822:Table 2
52.14	A3	final	6.35 percent	0.56	32	not stated; completers; R0019822:Table 2
104.28	A1	final	6.33 percent	0.72	32	not stated; completers; R0019822:Table 2
104.28	A2	final	6.41 percent	0.74	34	not stated; completers; R0019822:Table 2
104.28	A3	final	6.18 percent	0.58	32	not stated; completers; R0019822:Table 2
208.56	A1	final	6.26 percent	0.69	32	not stated; completers; R0019822:Table 2
208.56	A2	final	6.55 percent	0.94	34	not stated; completers; R0019822:Table 2
208.56	A3	final	6.21 percent	0.49	32	not stated; completers; R0019822:Table 2

Three point MACE (3 lines; O21)

Arm	Statistic	Events / N	Detail
A1	events	1 / 45	not stated; randomized; R0019822:Results
A2	events	3 / 49	not stated; randomized; R0019822:Results
A3	events	2 / 45	not stated; randomized; R0019822:Results

Hospitalization for heart failure (3 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	3 / 45	not stated; randomized; R0019822:Results
A2	events	3 / 49	not stated; randomized; R0019822:Results
A3	events	3 / 45	not stated; randomized; R0019822:Results

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 45	not stated; randomized; acute myocardial infarction and cerebrovascular accident; R0019822:Results
A1	events	3 / 45	not stated; randomized; hospitalized for heart failure; R0019822:Results
A2	events	3 / 49	not stated; randomized; acute myocardial infarction and cerebrovascular accident; R0019822:Results
A2	events	3 / 49	not stated; randomized; hospitalized for heart failure; R0019822:Results
A3	events	2 / 45	not stated; randomized; acute myocardial infarction and cerebrovascular accident; R0019822:Results
A3	events	3 / 45	not stated; randomized; hospitalized for heart failure; R0019822:Results