crossover randomized trial

NCT00456885

The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus

Design

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	lifestyle: none		41
A2	Placebo Placebo	lifestyle: none		40

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

Characteristic	Statistic	Whole trial ALL
age	max (years)	64
age	mean (years)	48
age	min (years)	24
age	sd (years)	11
bmi	max (kg/m2)	43
bmi	mean (kg/m2)	33
bmi	min (kg/m2)	27
bmi	sd (kg/m2)	4
female	n	41
other prediabetes	percent	24
sbp	mean (mmHg)	128
sbp	sd (mmHg)	14
waist	max (cm)	136
waist	mean (cm)	105
waist	min (cm)	86
waist	sd (cm)	12
weight	max (kg)	121
weight	mean (kg)	89
weight	min (kg)	65
weight	sd (kg)	14

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

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	change	-2.48 mmHg	-6.60 to 1.64	41	not stated; modified itt; R0017547:Table 2
16	A1	change	-2.5 mmHg	-6.6 to 1.6	41	not stated; modified itt; registry:outcomes
16	A2	change	-1.26 mmHg	-5.17 to 2.65	40	not stated; modified itt; R0017547:Table 2
16	A2	change	-1.3 mmHg	-5.2 to 2.6	40	not stated; modified itt; registry:outcomes

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	percent change	-2.77 percent		-4.26 to -1.28	41	not stated; modified itt; R0017547:Table 2
16	A2	percent change	0.48 percent		-0.94 to 1.90	40	not stated; modified itt; R0017547:Table 2

Weight loss of 5 percent or more (1 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	responders	30			11 /	not stated; other; R0017547:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 41	not stated; randomized; registry:adverse_events
	A2	events				0 / 41	not stated; randomized; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 41	not stated; randomized; registry:adverse_events
	A2	events				0 / 41	not stated; randomized; 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 /	not stated; other; R0017547:Results
	A2	events				0 /	not stated; other; R0017547:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	56				not stated; other; R0017547:Results
	A2	events	21				not stated; other; R0017547:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 /	not stated; other; R0017547:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 /	not stated; other; R0017547:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 /	not stated; other; R0017547:Results
	A2	events				0 /	not stated; other; R0017547:Results