parallel randomized trial

NCT00546728

The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance

Design

Randomized: 50
Start year: 2007
Treatment: 13.04 weeks, follow-up 13.04 weeks
Countries: United States (2 sites)
Sponsor: St. Paul Heart Clinic (industry)
Eligibility: no diabetes; waist 102 cm men or 88 cm women or more; IFG, HbA1c 5.7 percent or more, or IGT

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Metformin Metformin	lifestyle: not reported	25	25
A2	Exenatide 10 ug subcutaneous twice daily Exenatide	lifestyle: not reported	25	25

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

Characteristic	Statistic	Metformin A1	Exenatide 10 ug subcutaneous twice daily A2	Whole trial ALL
age: 18 or less	n	0	0
age: 18 to 65	n	25	25
age: 65 or older	n	0	0
age	mean (years)	58.4	58.7
age	sd (years)	10.1	10.0
bmi	mean (kg/m2)	35.8	35.3
bmi	sd (kg/m2)	7.0	5.5
female	n	18	20
hispanic	n	2	0
sbp	mean (mmHg)	125.8	130.6
sbp	sd (mmHg)	12.3	17.1
waist	mean (cm)	112.3	111.6
waist	sd (cm)	15.7	12.5
white	percent			100

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

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
13.04	A1	change	0.5 mmHg	10.2		25	not stated; randomized; R0022862:Table 2
13.04	A2	change	-5.4 mmHg	15.3		25	not stated; randomized; R0022862:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; registry:adverse_events
	A2	events				0 / 25	not stated; safety; registry:adverse_events

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; registry:adverse_events
	A2	events				0 / 25	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 / 25	not stated; safety; registry:adverse_events
	A2	events				0 / 25	not stated; safety; 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				0 / 25	not stated; randomized; registry:flow
	A2	events				0 / 25	not stated; randomized; registry:flow

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; randomized; registry:flow
	A2	events				0 / 25	not stated; randomized; registry:flow

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; registry:adverse_events
	A2	events				0 / 25	not stated; safety; registry:adverse_events