parallel randomized trial

S003101

Design

Randomized: 72
Start year: 2014
Treatment: 26 weeks, follow-up 26 weeks
Countries: Denmark (1 sites)
Sponsor: (mixed)
Eligibility: premenopausal women 18 or older; Rotterdam PCOS; BMI 25 or more and/or C-peptide above 0.6 nmol/L; no diabetes

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	lifestyle: not reported	48	48
A2	Placebo Placebo	lifestyle: not reported	24	24

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

Characteristic	Statistic	Liraglutide 1.8 mg subcutaneous once daily A1	Placebo A2
age	median (years)	31.4	26.2
age	q1 (years)	24.6	24.8
age	q3 (years)	35.6	31.5
bmi	mean (kg/m2)	33.3	33.3
bmi	sd (kg/m2)	5.1	4.6
egfr	mean (mL/min/1.73 m2)	112.8	117.5
egfr	sd (mL/min/1.73 m2)	13.3	9.7
female	n	48	24
hba1c	mean (mmol/mol)	34.2	34.6
hba1c	sd (mmol/mol)	2.8	3.4
sbp	mean (mmHg)	123	124
sbp	sd (mmHg)	9	9
waist	mean (cm)	102.6	102.6
waist	sd (cm)	10.8	11.1
weight	mean (kg)	94.2	91.3
weight	sd (kg)	15.4	13.6
white	n	45	22
white	percent	93.8	91.7

15 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				2 / 48	not stated; randomized; R0025661:Figure 1
	A2	events				1 / 24	not stated; randomized; R0025661:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				37 / 47	not stated; other; R0025661:Table 2
	A2	events				3 / 23	not stated; other; R0025661:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 47	not stated; other; R0025661:Table 2
	A2	events				0 / 23	not stated; other; R0025661:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 47	not stated; other; R0025661:Table 2
	A2	events				1 / 23	not stated; other; R0025661:Table 2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 47	not stated; other; R0025661:Table 2
	A2	events				0 / 23	not stated; other; R0025661:Table 2

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 48	not stated; randomized; abdominal pain; R0025661:Figure 1

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	2 / 47	not stated; other; cholecystectomy; R0025661:Table 2
A1	events	3 / 47	not stated; other; gallstone related pain; R0025661:Table 2
A2	events	1 / 23	not stated; other; gallstone related pain; R0025661:Table 2
A2	events	0 / 23	not stated; other; cholecystectomy; R0025661:Table 2