parallel randomized trial

NCT00359762

Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)

Design

Randomized: 1,029
Start year: 2006
Treatment: 234.81 weeks, follow-up 234.81 weeks
Countries: Austria, Czech Republic, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Mexico, Poland, Spain, Switzerland, United Kingdom
Sponsor: Eli Lilly and Amylin Pharmaceuticals (industry)
Eligibility: age 18 to 85; BMI 25 to below 40; HbA1c 6.5 to below 9.0 percent on maximum tolerated metformin

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide twice daily plus metformin	metformin; lifestyle: not reported	515	490
A2	Glimepiride Glimepiride plus metformin	metformin; lifestyle: not reported	514	487

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Glimepiride A2
age: 18 to 65	n	388	389
age: 65 or older	n	102	98
age	mean (years)	56	57
age	sd (years)	10	9
bmi	mean (kg/m2)	32.5	32.2
bmi	sd (kg/m2)	4.2	4.0
female	n	218	235
female	percent	44	48
hba1c	mean (percent)	7.5	7.4
hba1c	sd (percent)	0.7	0.7
sbp	mean (mmHg)	132.9	133.6
sbp	sd (mmHg)	15.7	15.4
waist	mean (cm)	108.3	107.6
waist	sd (cm)	11.8	11.5
weight	mean (kg)	92.6	90.9
weight	sd (kg)	16.6	15.1

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
156.54	A1 vs A2	md	-0.18 percent		-0.31 to -0.04		not stated; modified itt; registry:outcomes
156.54	A1	change	-0.30 percent	0.051		182	not stated; modified itt; registry:outcomes
156.54	A2	change	-0.12 percent	0.049		197	not stated; modified itt; registry:outcomes
234.81	A1	change	-0.36 percent	0.035		488	not stated; modified itt; registry:outcomes
234.81	A1 vs A2	md	-0.16 percent		-0.26 to -0.06		not stated; modified itt; registry:outcomes
234.81	A2	change	-0.21 percent	0.035		485	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (8 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
156.42	A1 vs A2	md	-5.3 kg	0.63			not stated; safety; sex:male; R0016082:Results
156.42	A1	change	-3.9 kg	0.33	-4.6 to -3.3	185	not stated; safety; R0016082:Table 2
156.42	A1 vs A2	md	-5.2 kg	0.46			not stated; safety; R0016082:Table 2
156.42	A1 vs A2	md	-5.2 kg	0.68			not stated; safety; sex:female; R0016082:Results
156.42	A2	change	1.3 kg	0.32	0.7 to 1.9	201	not stated; safety; R0016082:Table 2
156.54	A1 vs A2	md	-5.40 kg		-6.31 to -4.49		not stated; safety; registry:outcomes
156.54	A1	change	-3.92 kg	0.335		185	not stated; safety; registry:outcomes
156.54	A2	change	1.47 kg	0.319		201	not stated; safety; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (8 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	122 / 511	not stated; safety; R0016082:Results
A1	events	98 / 511	not stated; safety; R0016082:Results
A1	events	69 / 511	not stated; safety; R0016082:Results
A1	events	93 / 511	not stated; safety; R0016082:Results
A2	events	237 / 508	not stated; safety; R0016082:Results
A2	events	254 / 508	not stated; safety; R0016082:Results
A2	events	215 / 508	not stated; safety; R0016082:Results
A2	events	198 / 508	not stated; safety; R0016082:Results

Level 2 or 3 hypoglycemia (episode rate) (1 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1 vs A2	rate ratio	0.29		0.22 to 0.37		not stated; safety; registry:outcomes

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
156.42	A1	change	-2.5 mmHg	0.89	-4.2 to -0.7	183	not stated; safety; R0016082:Table 2
156.42	A1 vs A2	md	-5.2 mmHg	1.23			not stated; safety; R0016082:Table 2
156.42	A2	change	2.8 mmHg	0.85	1.1 to 4.4	203	not stated; safety; R0016082:Table 2
156.54	A1	final	130.58 mmHg	0.891		183	not stated; safety; registry:outcomes
156.54	A1 vs A2	md	-5.20 mmHg		-7.61 to -2.79		not stated; safety; registry:outcomes
156.54	A2	final	135.78 mmHg	0.845		203	not stated; safety; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 511	not stated; safety; renal failure acute; registry:adverse_events
	A2	events				1 / 508	not stated; safety; renal failure acute; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 515	not stated; randomized; registry:flow
	A2	events				2 / 514	not stated; randomized; registry:flow

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 511	not stated; safety; cardiac failure; registry:adverse_events
	A2	events				0 / 508	not stated; safety; cardiac failure; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				73 / 511	not stated; safety; registry:adverse_events
	A2	events				68 / 508	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				49 / 515	not stated; randomized; registry:flow
	A2	events				17 / 514	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				147 / 511	not stated; safety; registry:adverse_events
	A2	events				11 / 508	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				44 / 511	not stated; safety; registry:adverse_events
	A2	events				12 / 508	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				62 / 511	not stated; safety; registry:adverse_events
	A2	events				33 / 508	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 511	not stated; safety; registry:adverse_events
	A2	events				0 / 508	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 511	not stated; safety; cholecystitis; registry:adverse_events
A1	events	2 / 511	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 508	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	1 / 508	not stated; safety; cholecystitis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 511	not stated; safety; pancreatitis; registry:adverse_events
	A2	events				0 / 508	not stated; safety; pancreatitis; registry:adverse_events