parallel randomized trial

NCT02909933

Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity

Design

Randomized: 30
Start year: 2015
Treatment: 12 weeks, follow-up 12 weeks
Countries: Slovenia (1 sites)
Sponsor: University Medical Centre Ljubljana (non industry)
Eligibility: women 18 to menopause, PCOS phenotype A by Rotterdam criteria, BMI 30 or higher

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3 mg	lifestyle: standard	15	14
A2	Liraglutide plus metformin 1.2 to 1000 mg injection once daily Liraglutide 1.2 mg plus metformin 1000 mg BID	lifestyle: standard	15	14

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

Characteristic	Statistic	Liraglutide 3.0 mg subcutaneous once daily A1	Liraglutide plus metformin 1.2 to 1000 mg injection once daily A2	Whole trial ALL
age	mean (years)	34.6	31.6
age	sd (years)	6.1	5.9
bmi	mean (kg/m2)	39.2	37.5
bmi	sd (kg/m2)	5.5	5.3
female	n			30
waist	mean (cm)	110.1	105.2
waist	sd (cm)	12	10.7
weight	mean (kg)	111.1	102.5
weight	sd (kg)	14.8	9

7 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 / 14	not stated; completers; R0022935:Results
	A2	events				0 / 14	not stated; completers; R0022935:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 14	not stated; completers; R0022935:Results
	A2	events				6 / 14	not stated; completers; R0022935:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 14	not stated; completers; R0022935:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 14	not stated; completers; R0022935:Results
	A2	events				6 / 14	not stated; completers; R0022935:Results