parallel randomized trial

S003084

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Polycystic ovary syndromeS003084

Design

Randomized: 64
Start year: 2018
Treatment: 12 weeks, follow-up 16 weeks
Countries: China (1 sites)
Sponsor: (industry)
Eligibility: women 18 to 40 years, BMI 24 kg/m2 or more, PCOS by Rotterdam criteria, no diabetes

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: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Beinaglutide 0.2 mg subcutaneous three times daily Metformin plus beinaglutide (COMB)	metformin 850 mg BID; lifestyle: standard	32	30
A2	Standard care or no added treatment Metformin alone (MET)	metformin 850 mg BID; lifestyle: standard	32	30

Baseline characteristics

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

Characteristic	Statistic	Beinaglutide 0.2 mg subcutaneous three times daily A1	Standard care or no added treatment A2	Whole trial ALL
age	mean (years)	26.75	25.43
age	sd (years)	4.42	3.14
bmi	mean (kg/m2)	28.65	28.79
bmi	sd (kg/m2)	1.93	2.12
female	n			64
waist	mean (cm)	96.45
waist	median (cm)		89.65
waist	sd (cm)	6.99
weight	mean (kg)	73.95	72.68
weight	sd (kg)	6.71	6.23

Results

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

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 32	not stated; safety; R0019172:Results
	A2	events				0 / 32	not stated; safety; R0019172:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	8 / 32	not stated; randomized; R0019172:Table 4
A1	events	10 / 32	not stated; randomized; nausea and vomiting; R0019172:Results
A2	events	13 / 32	not stated; randomized; R0019172:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 32	not stated; randomized; R0019172:Table 4
	A2	events				2 / 32	not stated; randomized; R0019172:Table 4

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				8 / 32	not stated; randomized; R0019172:Table 4

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 32	not stated; safety; R0019172:Results
	A2	events				0 / 32	not stated; safety; R0019172:Results