crossover randomized trial

S003105

Design

Randomized: 18
Start year
Treatment: 3 weeks
Countries: (1 sites)
Sponsor: (industry)
Eligibility: age 18 to 70; BMI 18.5 to 40; HbA1c 7.0 to 9.5 percent (7.5 to 9.5 if diet only)

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 0.6 to 1.8 mg	diet only after OAD washout; lifestyle: not reported	18
A2	Placebo Placebo	diet only after OAD washout; lifestyle: not reported	18

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	58.6
age	sd (years)	6.9
bmi	mean (kg/m2)	29.7
bmi	sd (kg/m2)	4.2
hba1c	mean (percent)	7.8
hba1c	sd (percent)	0.6
other male	n	14
other male	percent	78
white	percent	100

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

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; safety; R0025338:p8
A1	events	0 / 18	not stated; safety; R0025338:p8
A1	events	0 / 18	not stated; safety; R0025338:p8
A2	events	0 / 18	not stated; safety; R0025338:p8
A2	events	0 / 18	not stated; safety; R0025338:p8
A2	events	0 / 18	not stated; safety; R0025338:p8

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate				18	not stated; safety; R0025338:p8
	A2	rate				18	not stated; safety; R0025338:p8

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025338:p8
	A2	events				0 / 18	not stated; safety; R0025338:p8

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025338:p8
	A2	events				0 / 18	not stated; safety; R0025338:p8

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025338:p8
	A2	events				0 / 18	not stated; safety; R0025338:p8

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025338:p8
	A2	events				0 / 18	not stated; safety; R0025338:p8

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025338:p8
	A2	events				0 / 18	not stated; safety; R0025338:p8

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0025338:p8
	A2	events				0 / 18	not stated; safety; R0025338:p8