crossover randomized trial

NCT01562678

Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI

Design

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle or metformin; lifestyle: not reported	28	18
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	lifestyle or metformin; lifestyle: not reported	28	18

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

Characteristic	Statistic	Placebo A1	Liraglutide 1.8 mg subcutaneous once daily A2	Whole trial ALL
age	mean (years)			52.5
age	sd (years)			10.5
bmi	mean (kg/m2)	31.2	31.9
bmi	se (kg/m2)	1.7	1.7
female	n			12
waist	mean (cm)	105.1	106.8
waist	se (cm)	3.5	3.5
weight	mean (kg)	93.4	94.7
weight	se (kg)	4.8	4.7

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
2.43	A1	final	6.7 percent	0.2		18	not stated; completers; R0022856:Table 2
2.43	A2	final	6.7 percent	0.2		18	not stated; completers; R0022856:Table 2

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
2.43	A1	final	91.1 kg	1.0		18	not stated; completers; R0022856:Table 2
2.43	A2	final	91.0 kg	1.0		18	not stated; completers; R0022856:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 18	not stated; other; R0022856:Results
	A2	events				7 / 18	not stated; other; R0022856:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; safety; registry:adverse_events
	A2	events				0 / 28	not stated; safety; registry:adverse_events