parallel randomized trial

NCT01590433

A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes

Design

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	lifestyle: none	127	75
A2	Placebo Placebo plus hypocaloric diet	lifestyle: standard	55	33

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Placebo A2
age	mean (years)	43.9	44.6
age	sd (years)	11.9	13.7
asian	n	1	2
black	n	33	11
bmi	mean (kg/m2)	36.1	34.8
bmi	sd (kg/m2)	5.3	5.0
female	n	127	55
hba1c	mean (percent)	5.6	5.6
hba1c	sd (percent)	0.3	0.3
hispanic	n	18	4
other race american indian alaska native	n	1	0
other race native hawaiian pacific islander	n	0	1
sbp	mean (mmHg)	125.1	121.2
sbp	sd (mmHg)	12.6	14.4
waist	mean (cm)	112.1
waist	sd (cm)	17.5
weight	mean (kg)	95.9	94.0
weight	sd (kg)	14.6	13.1
white	n	92	41

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

Percent body weight change (3 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	percent change	-6.5 percent	0.4	75	not stated; completers; registry:outcomes
12	A1 vs A2	md	percent			not stated; completers; registry:outcomes
12	A2	percent change	-7.5 percent	0.6	33	not stated; completers; registry:outcomes

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders				42 / 75	not stated; completers; R0022102:Table 2
12	A2	responders				25 / 33	not stated; completers; R0022102:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 127	not stated; randomized; registry:adverse_events
	A2	events				0 / 55	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 / 127	not stated; randomized; registry:adverse_events
	A2	events				0 / 55	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				11 / 127	not stated; randomized; registry:flow
	A2	events				3 / 55	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				89 / 127	not stated; randomized; registry:adverse_events
	A2	events				14 / 55	not stated; randomized; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 127	not stated; randomized; registry:adverse_events
	A2	events				1 / 55	not stated; randomized; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				24 / 127	not stated; randomized; registry:adverse_events
	A2	events				9 / 55	not stated; randomized; registry:adverse_events