parallel randomized trial

NCT00516074

A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

Design

Randomized: 54
Start year: 2007
Treatment: 12 weeks, follow-up 12 weeks
Countries: Canada, Netherlands (5 sites)
Sponsor: Eli Lilly and Company (registry sponsor AstraZeneca) (industry)
Eligibility: age 18 to 75; HbA1c 6.5 to 9.5 percent; BMI 25 to 40; metformin and/or thiazolidinedione

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide BID	metformin and/or TZD; lifestyle: not reported	28	28
A2	Placebo Placebo BID	metformin and/or thiazolidinedione; lifestyle: not reported	26	26

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)	57	54
age	sd (years)	11	10
asian	n	1	1
asian	percent	4	4
black	n	2	0
black	percent	7	0
bmi	mean (kg/m2)	29.5	30.1
bmi	sd (kg/m2)	3.4	3.9
diabetes duration	mean (years)	7	6
diabetes duration	sd (years)	4	4
female	n	9	15
hba1c	mean (percent)	7.5	7.1
hba1c	sd (percent)	0.9	0.7
hispanic	n	1	0
hispanic	percent	4	0
other male	n	19	11
other male	percent	68	42
sbp	mean (mmHg)	139.4	138.6
sbp	sd (mmHg)	13.9	18.7
weight	mean (kg)	91.6	85.9
weight	sd (kg)	15.2	12.2
white	n	24	25
white	percent	86	96

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-0.15 percent	0.16	27	not stated; modified itt; registry:outcomes
12	A1 vs A2	md	-0.3 percent	0.2		not stated; modified itt; R0019195:Results
12	A2	change	0.12 percent	0.17	25	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-1.8 kg	0.4	28	not stated; modified itt; R0019195:Results
12	A1 vs A2	md	-1.5 kg	0.6		not stated; modified itt; R0019195:Results
12	A2	change	-0.3 kg	0.4	26	not stated; modified itt; R0019195:Results

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		0 / 28	not stated; modified itt; R0019195:Results
A1	events	7	28	not stated; modified itt; R0019195:Results
A2	events		0 / 26	not stated; modified itt; R0019195:Results
A2	events	4	26	not stated; modified itt; R0019195:Results

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.81 mmHg	2.67		26	not stated; modified itt; registry:outcomes
12	A2	change	-0.34 mmHg	2.72		25	not stated; modified itt; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 28	not stated; modified itt; registry:adverse_events
	A2	events				1 / 26	not stated; modified itt; 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 / 28	not stated; randomized; registry:flow
	A2	events				1 / 26	not stated; randomized; registry:flow

Nausea (4 lines; O27A)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	36	28	not stated; modified itt; R0019195:Results
A1	events		10 / 28	not stated; modified itt; registry:adverse_events
A2	events	19	26	not stated; modified itt; R0019195:Results
A2	events		5 / 26	not stated; modified itt; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 28	not stated; modified itt; registry:adverse_events
	A2	events				2 / 26	not stated; modified itt; registry:adverse_events