parallel randomized trial

S003109

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)S003109

Design

Randomized: 39
Start year
Treatment: 12 weeks, follow-up 12 weeks
Countries: China
Sponsor: (non industry)
Eligibility: newly diagnosed, drug naive; age 20 to 65; BMI 20 to 35; FPG 7.0 to 16.7 mmol/L

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment CSII alone	short term CSII with insulin aspart or lispro to 14 days of euglycemia, then diet and exercise guidance; lifestyle: standard	19
A2	Liraglutide 1.2 mg subcutaneous once daily CSII plus liraglutide	short term CSII with insulin aspart or lispro to 14 days of euglycemia, then diet and exercise guidance; lifestyle: standard	20

Baseline characteristics

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

Characteristic	Statistic	Standard care or no added treatment A1	Liraglutide 1.2 mg subcutaneous once daily A2
age	mean (years)	42.1	42.3
age	sd (years)	7.6	9.9
bmi	mean (kg/m2)	25.5	25.4
bmi	sd (kg/m2)	2.4	2.8
female	n	4	5
hba1c	mean (percent)	10.2	10.0
hba1c	sd (percent)	2.0	2.1
sbp	mean (mmHg)	116.5	118.2
sbp	sd (mmHg)	12.3	11.7
waist	mean (cm)	89.0	89.4
waist	sd (cm)	6.9	7.9
weight	mean (kg)	71.6	71.0
weight	sd (kg)	8.7	8.2

Results

5 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	final	6.3 percent	0.7			not stated; other; R0026431:Results
12	A2	final	6.0 percent	0.5			not stated; other; R0026431:Results

Body weight change in kilograms (diabetes) (1 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A2	final	66.2 kg	9.3			not stated; other; R0026431:Results

Level 2 or 3 hypoglycemia (participants) (2 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 19	not stated; safety; R0026431:Safety Issues
	A2	events				0 / 20	not stated; safety; R0026431:Safety Issues