parallel randomized trial

GETGOAL-X

A Randomized, Open-label, Active-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Type 2 diabetes (adults)NCT00707031S001439

Design

Randomized: 639
Start year: 2008
Treatment: 24 weeks
Countries: multinational (122 sites)
Sponsor: Sanofi (industry)
Eligibility: age 21 to 84; HbA1c 7 to 10 percent; metformin at least 1.5 g/day

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: while on treatment
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug once daily	metformin at least 1.5 g/day; lifestyle: not reported	320	315
A2	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	metformin at least 1.5 g/day; lifestyle: not reported	319	315

Baseline characteristics

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

Characteristic	Statistic	Lixisenatide 20 ug subcutaneous once daily A1	Exenatide 10 ug subcutaneous twice daily A2
age	mean (years)	57.3	57.6
age	sd (years)	9.2	10.7
asian	n	3	4
black	n	8	10
bmi	mean (kg/m2)	33.68	33.51
bmi	sd (kg/m2)	6.27	6.54
diabetes duration	mean (years)	6.78	6.75
diabetes duration	sd (years)	5.54	4.87
female	n	167	129
hba1c	mean (percent)	7.95	7.97
hba1c	sd (percent)	0.81	0.78
hispanic	n	87	83
other race other	n	11	10
weight	mean (kg)	94.0	96.1
weight	sd (kg)	19.6	22.5
white	n	296	292

Analyses this trial contributes to

Results

61 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	95% CI	Events / N	Detail
24	A1 vs A2	md	0.17 percent		0.033 to 0.297		while on treatment; modified itt; R0022279:Results
24	A1	change	-0.79 percent	0.05		295	while on treatment; modified itt; R0022279:Results
24	A2	change	-0.96 percent	0.05		297	while on treatment; modified itt; R0022279:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-2.96 kg	0.23		295	while on treatment; modified itt; R0022279:Results
24	A1 vs A2	md	1.02 kg		0.456 to 1.581		while on treatment; modified itt; R0022279:Results
24	A2	change	-3.98 kg	0.23		296	while on treatment; modified itt; R0022279:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	48.5			295	while on treatment; modified itt; R0022279:Results
24	A2	responders	49.8			297	while on treatment; modified itt; R0022279:Results

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 318	while on treatment; safety; registry:outcomes
A1	events	16 / 318	while on treatment; safety; registry:outcomes
A1	events	0 / 318	not stated; safety; R0022279:Results
A1	events	8 / 318	not stated; safety; R0022279:Results
A2	events	25 / 316	not stated; safety; R0022279:Results
A2	events	0 / 316	while on treatment; safety; registry:outcomes
A2	events	0 / 316	not stated; safety; R0022279:Results
A2	events	46 / 316	while on treatment; safety; registry:outcomes

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-2.9 mmHg				not stated; safety; R0022279:Results
24	A2	change	-2.5 mmHg				not stated; safety; R0022279:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	25.1			295	while on treatment; modified itt; R0022279:Results
24	A2	responders	31.4			296	while on treatment; modified itt; R0022279:Results

Health related quality of life total score (any instrument) (5 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.09 points	0.031		302	while on treatment; modified itt; registry:outcomes
24	A1	change	-0.09 points				not stated; modified itt; R0022279:Results
24	A1 vs A2	md	-0.03 points		-0.111 to 0.043		not stated; modified itt; R0022279:Results
24	A2	change	-0.06 points	0.032		292	while on treatment; modified itt; registry:outcomes
24	A2	change	-0.06 points				not stated; modified itt; R0022279:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	2.8	318	not stated; safety; R0022279:Abstract
A1	events		26 / 318	while on treatment; safety; registry:adverse_events
A2	events		22 / 316	while on treatment; safety; registry:adverse_events
A2	events	2.2	316	not stated; safety; R0022279:Abstract

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	45 / 320	not stated; randomized; registry:flow
A1	events	33 / 318	not stated; safety; R0022279:Results
A2	events	45 / 319	not stated; randomized; registry:flow
A2	events	41 / 316	not stated; safety; R0022279:Results

Nausea (4 lines; O27A)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	24.5	318	not stated; safety; R0022279:Results
A1	events		91 / 318	while on treatment; safety; registry:adverse_events
A2	events		119 / 316	while on treatment; safety; registry:adverse_events
A2	events	35.1	316	not stated; safety; R0022279:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				41 / 318	while on treatment; safety; registry:adverse_events
	A2	events				49 / 316	while on treatment; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				48 / 318	while on treatment; safety; registry:adverse_events
	A2	events				54 / 316	while on treatment; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 318	while on treatment; safety; registry:adverse_events
	A2	events				17 / 316	while on treatment; safety; registry:adverse_events

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				20 / 318	not stated; safety; R0022279:Results
	A2	events				24 / 316	not stated; safety; R0022279:Results

Gallbladder and biliary disease (6 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 318	while on treatment; safety; cholecystitis; registry:adverse_events
A1	events	1 / 318	while on treatment; safety; cholecystitis acute; registry:adverse_events
A1	events	0 / 318	while on treatment; safety; cholecystitis chronic; registry:adverse_events
A2	events	0 / 316	while on treatment; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 316	while on treatment; safety; cholecystitis chronic; registry:adverse_events
A2	events	1 / 316	while on treatment; 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 / 318	not stated; safety; R0022279:Results
	A2	events				0 / 316	not stated; safety; R0022279:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 318	while on treatment; safety; registry:adverse_events
	A2	events				1 / 316	while on treatment; safety; registry:adverse_events

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 318	while on treatment; safety; retinopathy; registry:adverse_events
	A2	events				0 / 316	while on treatment; safety; retinopathy; registry:adverse_events

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 318	while on treatment; safety; suicide attempt; registry:adverse_events
	A2	events				1 / 316	while on treatment; safety; suicide attempt; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 318	while on treatment; safety; pancreatic carcinoma; registry:adverse_events
	A2	events				1 / 316	while on treatment; safety; pancreatic carcinoma; registry:adverse_events