parallel randomized trial

LIPT

A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.

Polycystic ovary syndrome NCT02073929S000948

Design

Randomized: 72
Start year: 2014
Treatment: 26 weeks, follow-up 26 weeks
Countries: Denmark
Sponsor: Jens Faber (investigator initiated) (mixed)
Eligibility: Rotterdam PCOS; BMI over 25 or insulin resistance; non hormonal contraception; no diabetes or CVD

Conduct and analysis

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

Arms

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

Baseline characteristics

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)	113	118
egfr	sd (mL/min/1.73 m2)	13	10
female	n	48	24
hba1c	mean (mmol/mol)	34.2	34.6
hba1c	sd (mmol/mol)	2.8	3.4
other race other	n	3	2
other total testosterone	median (nmol/L)	1.23	1.35
other total testosterone	q1 (nmol/L)	0.91	0.95
other total testosterone	q3 (nmol/L)	1.63	1.93
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

Analyses this trial contributes to

Results

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

Percent body weight change (short trials) (1 lines; O10B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	-5.6 percent				not stated; other; R0022129:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 48	not stated; safety; registry:adverse_events
	A2	events				1 / 24	not stated; safety; registry:adverse_events

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; registry:flow
	A2	events				1 / 24	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				37 / 48	not stated; safety; registry:adverse_events
	A2	events				3 / 24	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 48	not stated; safety; registry:adverse_events
	A2	events				0 / 24	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 48	not stated; safety; registry:adverse_events
	A2	events				1 / 24	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 48	not stated; safety; registry:adverse_events
	A2	events				0 / 24	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 48	not stated; safety; gallbladder stone attack; registry:adverse_events
	A2	events				1 / 24	not stated; safety; gallbladder stone attack; registry:adverse_events