parallel randomized trial

GETGOAL-S

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With Sulfonylurea

Type 2 diabetes (adults)NCT00713830S000491

Design

Randomized: 859
Start year: 2008
Treatment: 24 weeks, follow-up 120 weeks
Countries: multinational
Sponsor: Sanofi (industry)
Eligibility: adults on sulfonylurea with or without metformin; HbA1c 7 to 10 percent

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
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	Placebo Placebo	sulfonylurea with or without metformin; lifestyle: standard	286	274
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug once daily	sulfonylurea with or without metformin; lifestyle: standard	573	544

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Lixisenatide 20 ug subcutaneous once daily A2
age	mean (years)	57.8	57.0
age	sd (years)	10.1	9.8
asian	n	125	260
black	n	9	17
female	n	135	290
hba1c	mean (percent)	8.21	8.28
hba1c	sd (percent)	0.84	0.86
hispanic	n	5	18
weight	mean (kg)	84.42	82.30
weight	sd (kg)	22.83	21.76
white	n	151	297

Analyses this trial contributes to

Results

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.10 percent	0.071		274	while on treatment; modified itt; registry:outcomes
24	A2	change	-0.85 percent	0.061		544	while on treatment; modified itt; registry:outcomes
24	A2 vs A1	md	-0.74 percent		-0.867 to -0.621		while on treatment; modified itt; registry:outcomes
24	A2 vs A1	md	-0.92 percent	0.09	-1.10 to -0.74		not stated; modified itt; race:asian; R0021439:Table 4
24	A2 vs A1	md	-1.1 percent		-1.407 to -0.803		not stated; modified itt; region:japan; R0012857: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	-0.93 kg	0.234		278	while on treatment; modified itt; registry:outcomes
24	A2	change	-1.76 kg	0.202		554	while on treatment; modified itt; registry:outcomes
24	A2 vs A1	md	-0.11 kg		-0.798 to 0.586		not stated; modified itt; region:japan; R0012857:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	13.5			274	while on treatment; modified itt; registry:outcomes
24	A2	responders	36.4			544	while on treatment; modified itt; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	1 / 285	while on treatment; safety; registry:outcomes
A1	events	51 / 285	while on treatment; safety; registry:outcomes
A2	events	2 / 574	while on treatment; safety; registry:outcomes
A2	events	127 / 574	while on treatment; safety; registry:outcomes

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	7.2			278	while on treatment; modified itt; registry:outcomes
24	A2	responders	14.4			554	while on treatment; modified itt; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 285	while on treatment; safety; Renal failure acute; registry:adverse_events
	A2	events				1 / 574	while on treatment; safety; Renal failure acute; 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 / 285	while on treatment; safety; Cardiac failure congestive; registry:adverse_events
	A2	events				1 / 574	while on treatment; safety; Cardiac failure congestive; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				35 / 285	while on treatment; safety; registry:adverse_events
	A2	events				58 / 574	while on treatment; 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				23 / 286	not stated; randomized; registry:flow
	A2	events				71 / 573	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				25 / 285	while on treatment; safety; registry:adverse_events
	A2	events				161 / 574	while on treatment; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 285	while on treatment; safety; registry:adverse_events
	A2	events				61 / 574	while on treatment; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	27 / 285	while on treatment; safety; registry:adverse_events
A1	events	1 / 285	while on treatment; safety; registry:adverse_events
A2	events	71 / 574	while on treatment; safety; registry:adverse_events
A2	events	1 / 574	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				11 / 285	while on treatment; safety; registry:adverse_events
	A2	events				30 / 574	while on treatment; safety; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 285	while on treatment; safety; Cholelithiasis; registry:adverse_events
A1	events	0 / 285	while on treatment; safety; Cholecystitis; registry:adverse_events
A2	events	1 / 574	while on treatment; safety; Cholelithiasis; registry:adverse_events
A2	events	2 / 574	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				1 / 285	while on treatment; safety; registry:adverse_events
	A2	events				1 / 574	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				0 / 285	while on treatment; safety; Vitreous haemorrhage; registry:adverse_events
	A2	events				1 / 574	while on treatment; safety; Vitreous haemorrhage; registry:adverse_events