parallel randomized trial

GETGOAL-L-ASIA

A Randomized, Double-Blind, Placebo-Controlled, 2-arm Parallel-group, Multicenter Study With a 24-Week Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Sulfonylurea

Type 2 diabetes (adults)NCT00866658S000488

Design

Randomized: 311
Start year: 2009
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan, Republic of Korea, Taiwan, Philippines (57 sites)
Sponsor: Sanofi (industry)
Eligibility: age 25 to 81; type 2 diabetes at least 1 year; stable basal insulin at least 10 U/day with or without sulfonylurea; HbA1c 7 to 10 percent

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: not stated
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	basal insulin with or without sulfonylurea; lifestyle: standard	154	146	133
A2	Placebo Placebo	basal insulin with or without sulfonylurea; lifestyle: standard	157	154	144

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	Placebo A2
age	mean (years)	58.7	58.0
age	sd (years)	10.2	10.1
asian	n	154	157
asian	percent	100	100
bmi	mean (kg/m2)	25.4	25.2
bmi	sd (kg/m2)	3.7	3.9
diabetes duration	mean (years)	13.7	14.1
diabetes duration	sd (years)	7.7	7.7
female	n	85	77
hba1c	mean (percent)	8.54	8.52
hba1c	sd (percent)	0.73	0.78
insulin dose	mean (U/day)	24.9	24.1
insulin dose	sd (U/day)	14.0	14.2
other male	n	69	80
other male	percent	44.8	51.0
other sulfonylurea use	n	108	111
other sulfonylurea use	percent	70.1	70.7
weight	mean (kg)	65.93	65.60
weight	sd (kg)	13.00	12.47

Analyses this trial contributes to

Results

45 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	-0.77 percent				not stated; modified itt; R0022626:Results
24	A1 vs A2	md	-0.88 percent		-1.116 to -0.650		not stated; modified itt; R0022626:Results
24	A1	change	-0.77 percent	0.137		146	while on treatment; modified itt; registry:outcomes
24	A2	change	0.11 percent				not stated; modified itt; R0022626:Results
24	A2	change	0.11 percent	0.131		154	while on treatment; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-0.38 kg			not stated; modified itt; R0022626:Results
24	A1	change	-0.38 kg	0.284	150	while on treatment; modified itt; registry:outcomes
24	A2	change	0.06 kg	0.271	157	while on treatment; modified itt; registry:outcomes
24	A2	change	0.06 kg			not stated; modified itt; R0022626:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	35.6			146	while on treatment; modified itt; registry:outcomes
24	A2	responders	5.2			154	while on treatment; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 154	while on treatment; safety; R0022626:Results
A1	events	66 / 154	while on treatment; safety; R0022626:Table 2
A1	events	59 / 154	while on treatment; safety; R0022626:Table 2
A2	events	0 / 157	while on treatment; safety; R0022626:Results
A2	events	37 / 157	while on treatment; safety; R0022626:Table 2
A2	events	32 / 157	while on treatment; safety; R0022626:Table 2

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	7.3			150	while on treatment; modified itt; registry:outcomes
24	A2	responders	4.5			157	while on treatment; modified itt; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 154	while on treatment; safety; R0022626:Table 2
	A2	events				1 / 157	while on treatment; safety; R0022626:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 154	while on treatment; safety; R0022626:Table 2
	A2	events				9 / 157	while on treatment; safety; R0022626:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 154	while on treatment; safety; R0022626:Table 2
	A2	events				5 / 157	while on treatment; safety; R0022626:Table 2

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				61 / 154	while on treatment; safety; R0022626:Table 2
	A2	events				7 / 157	while on treatment; safety; R0022626:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				28 / 154	while on treatment; safety; R0022626:Table 2
	A2	events				3 / 157	while on treatment; safety; R0022626:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 154	while on treatment; safety; R0022626:Table 2
	A2	events				4 / 157	while on treatment; safety; R0022626:Table 2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 154	while on treatment; safety; R0022626:Table 2
	A2	events				4 / 157	while on treatment; safety; R0022626:Table 2

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	6 / 154	while on treatment; safety; nausea; R0022626:Results
A1	events	4 / 154	while on treatment; safety; vomiting; R0022626:Results
A2	events	0 / 157	while on treatment; safety; nausea; R0022626:Results
A2	events	0 / 157	while on treatment; safety; vomiting; R0022626:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 154	while on treatment; safety; R0022626:Results
	A2	events				0 / 157	while on treatment; safety; R0022626:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 154	while on treatment; safety; R0022626:Results
	A2	events				0 / 157	while on treatment; safety; R0022626:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 154	while on treatment; safety; R0022626:Results
	A2	events				0 / 157	while on treatment; safety; R0022626:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 154	while on treatment; safety; R0022626:Results
	A2	events				1 / 157	while on treatment; safety; R0022626:Results