parallel randomized trial

NCT01911468

Short-term Combined Treatment With Liraglutide and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome and Previous Poor Response to Metformin

Polycystic ovary syndrome NCT01911468S000723

Design

Randomized: 40
Start year: 2011
Treatment: 12 weeks, follow-up 12 weeks
Countries: Slovenia (1 sites)
Sponsor: University Medical Centre Ljubljana (non industry)
Eligibility: premenopausal women over 18; BMI 30 or more; metformin 6 months or longer with under 5 percent weight loss; 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: none

Arms

Arm	Treatment	Background	Analyzed
A1	Metformin Metformin 1000 mg BID	lifestyle: none	14
A2	Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg QD	lifestyle: none	11
A3	Liraglutide plus metformin 1.2 to 1000 mg injection once daily Liraglutide 1.2 mg QD plus metformin 1000 mg BID	lifestyle: none	11

Baseline characteristics

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

Characteristic	Statistic	Metformin A1	Liraglutide 1.2 mg subcutaneous once daily A2	Liraglutide plus metformin 1.2 to 1000 mg injection once daily A3	Whole trial ALL
age	mean (years)	31.3	31.5	31.1
age	sd (years)	9.4	6.4	5.1
bmi	mean (kg/m2)	36.6	39.3	37.6
bmi	sd (kg/m2)	3.5	4.2	5.1
female	percent				100
other menstrual cycles per month	mean (cycles per month)	0.7	0.6	0.5
other menstrual cycles per month	sd (cycles per month)	0.4	0.3	0.3
sbp	mean (mmHg)	121.9	123.3	125.0
sbp	sd (mmHg)	13.1	15.4	13.0
waist	mean (cm)	122.3	124.9	121.9
waist	sd (cm)	7.0	9.9	17.7
weight	mean (kg)	103.2	108.9	105.5
weight	sd (kg)	6.3	15.1	20.6

Analyses this trial contributes to

Results

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

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 /	not stated; randomized; R0018103:Results
A2	events	2 /	not stated; randomized; R0018103:Results
A3	events	1 /	not stated; randomized; R0018103:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 14	not stated; completers; R0018103:Results
A2	events	6 / 11	not stated; completers; R0018103:Results
A3	events	6 / 11	not stated; completers; R0018103:Results

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	1 / 14	not stated; completers; R0018103:Results
A2	events	6 / 11	not stated; completers; R0018103:Results
A3	events	6 / 11	not stated; completers; R0018103:Results

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 /	not stated; randomized; R0018103:Results
A2	events	2 /	not stated; randomized; R0018103:Results
A3	events	0 /	not stated; randomized; R0018103:Results

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				1 /	not stated; randomized; acute cholangitis caused by gallstones; R0018103:Results