parallel randomized trial

S003086

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)S003086

Design

Randomized: 159
Start year: 2017
Treatment: 24 weeks, follow-up 24 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: age 18 to 65; HbA1c 6.5 percent or more; BMI 24 or more; SBP 90 to 130 mmHg

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: linear mixed model

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	metformin and or sulfonylurea; lifestyle: not reported	79	79
A2	Insulin glargine Insulin glargine	metformin or sulfonylurea or both; lifestyle: not reported	80	80

Baseline characteristics

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Insulin glargine A2
age	mean (years)	49.37	47.63
age	sd (years)	8.43	9.65
bmi	mean (kg/m2)	27.607	27.064
bmi	sd (kg/m2)	2.027	1.937
diabetes duration	median (years)	3.0	3.0
diabetes duration	q1 (years)	1.0	2.0
diabetes duration	q3 (years)	5.0	4.0
hba1c	mean (percent)	9.726	9.644
hba1c	sd (percent)	1.974	1.545
other background: metformin only	n	27	20
other background: metformin only	percent	34.18	25.00
other background: metformin sulfonylurea	n	42	48
other background: metformin sulfonylurea	percent	53.16	60.00
other background: sulfonylurea only	n	10	12
other background: sulfonylurea only	percent	12.66	15.00
other male	n	42	45
other male	percent	53.16	56.25
other uac	median (mg/L)	80.0	80.0
other uac	q1 (mg/L)	50.0	40.0
other uac	q3 (mg/L)	150.0	108.8
weight	mean (kg)	75.241	73.575
weight	sd (kg)	8.167	6.106

Analyses this trial contributes to

Results

4 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	-2.574 percent	2.020			not stated; randomized; R0019483:Table 2
24	A2	change	-1.562 percent	1.513			not stated; randomized; R0019483:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-5.388 kg	8.334			not stated; randomized; R0019483:Table 2
24	A2	change	-0.658 kg	5.915			not stated; randomized; R0019483:Table 2