crossover randomized trial

S003057

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)S003057

Design

Randomized: 200
Start year: 2011
Treatment: 12 weeks, follow-up 36 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: newly diagnosed type 2 diabetes within 3 months; HbA1c 10.5 percent or less; BMI above 24 and below 40

Conduct and analysis

Blinding: not reported
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide plus metformin	metformin 0.5 g twice daily; lifestyle: not reported	200
A2	Premixed insulin Biphasic insulin aspart 30 plus metformin	metformin 0.5 g twice daily; lifestyle: not reported	200

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age sequence:group_a	mean (years)	58.1
age sequence:group_b	mean (years)	57.4
age	max (years)	68
age	mean (years)	59
age	min (years)	48
bmi sequence:group_a	mean (kg/m2)	27.3
bmi sequence:group_b	mean (kg/m2)	28.1
diabetes duration sequence:group_a	mean (years)	0.8
diabetes duration sequence:group_b	mean (years)	0.7
female	n	119
hba1c sequence:group_a	mean (percent)	8.6
hba1c sequence:group_b	mean (percent)	8.8
other ethnicity han sequence:group_a	percent	80
other ethnicity han sequence:group_b	percent	82
other ethnicity manchu sequence:group_a	percent	12
other ethnicity manchu sequence:group_b	percent	10
other ethnicity mongolian sequence:group_a	percent	6
other ethnicity mongolian sequence:group_b	percent	4
other ethnicity tibetan sequence:group_a	percent	2
other ethnicity tibetan sequence:group_b	percent	4
other male sequence:group_a	n	40
other male sequence:group_a	percent	40
other male sequence:group_b	n	41
other male sequence:group_b	percent	41
waist sequence:group_a	mean (cm)	109.6
waist sequence:group_b	mean (cm)	107.3
weight sequence:group_a	mean (kg)	81
weight sequence:group_b	mean (kg)	82

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	Detail
12	A1	change	-1.8 percent	not stated; other; R0025399:p3
12	A1	final	6.8 percent	not stated; other; R0025399:Table II
12	A2	change	-1.3 percent	not stated; other; R0025399:p3
12	A2	final	6.5 percent	not stated; other; R0025399:Table II

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

Week	Arm	Statistic	Estimate	SE or SD	Detail
12	A1	change	-3.2 kg	0.4	not stated; other; R0025399:p3
12	A1	final	78 kg		not stated; other; R0025399:Table II
12	A2	change	2.6 kg	0.3	not stated; other; R0025399:p3
12	A2	final	85 kg		not stated; other; R0025399:Table II