parallel randomized trial

NCT04029272

Study on the Effect of Metformin vs Metformin Combined With GLP-1 RA (Exenatide) on Overweight/Obese Patients With Polycystic Ovary Syndrome (PCOS)

Design

Randomized: 50
Start year: 2019
Treatment: 12 weeks, follow-up 12 weeks
Countries: China (1 sites)
Sponsor: Peking Union Medical College Hospital (non industry)
Eligibility: women 18 to 40 years; Rotterdam PCOS; BMI 25 or more; no diabetes

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment Metformin (MET)	metformin 500 mg TID; ethinylestradiol 0.035 mg and cyproterone acetate 2 mg (Diane-35) cyclic; lifestyle: none	25	21	21
A2	Exenatide extended release 2 mg subcutaneous once weekly Exenatide QW plus metformin (COM)	metformin 500 mg TID; ethinylestradiol 0.035 mg and cyproterone acetate 2 mg (Diane-35) cyclic; lifestyle: none	25	19	19

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

Characteristic	Statistic	Standard care or no added treatment A1	Exenatide extended release 2 mg subcutaneous once weekly A2	Whole trial ALL
age	mean (years)	28.17	30.10
age	sd (years)	4.40	4.52
bmi	mean (kg/m2)	30.62	31.51
bmi	sd (kg/m2)	3.42	4.20
female	n			50
waist	mean (cm)	96.18	98.94
waist	sd (cm)	8.56	10.77
weight	mean (kg)	79.25	84.14
weight	sd (kg)	10.75	12.82

12 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				1 / 25	not stated; randomized; R0011463:Results
	A2	events				1 / 25	not stated; randomized; R0011463:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 25	not stated; randomized; R0011463:Table 4
	A2	events				11 / 25	not stated; randomized; R0011463:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 25	not stated; randomized; R0011463:Table 4
	A2	events				2 / 25	not stated; randomized; R0011463:Table 4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 25	not stated; randomized; R0011463:Table 4
	A2	events				9 / 25	not stated; randomized; R0011463:Table 4

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 25	not stated; randomized; R0011463:Table 4
	A2	events				2 / 25	not stated; randomized; R0011463: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				1 / 25	not stated; randomized; R0011463:Results
	A2	events				1 / 25	not stated; randomized; R0011463:Results