parallel randomized trial

GETGOAL-L

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin

Type 2 diabetes (adults)NCT00715624S002023

Design

Randomized: 496
Start year: 2008
Treatment: 24 weeks, follow-up 125 weeks
Countries: multinational
Sponsor: Sanofi (industry)
Eligibility: adults; HbA1c 7.0 to 10.0 percent; stable basal insulin with or without metformin

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	basal insulin with or without metformin; lifestyle: not reported	167	158
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide	basal insulin with or without metformin; lifestyle: not reported	329	304

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)	56.9	57.4
age	sd (years)	9.8	9.5
asian	n	30	53
black	n	6	14
bmi	mean (kg/m2)	32.56	31.91
bmi	sd (kg/m2)	6.32	6.17
diabetes duration	mean (years)	12.43	12.48
diabetes duration	sd (years)	6.33	7.04
female	n	85	182
hba1c	mean (percent)	8.37	8.42
hba1c	sd (percent)	0.84	0.88
hispanic	n	40	94
insulin dose	mean (U/day)	57.73	53.43
insulin dose	sd (U/day)	34.54	33.89
metformin use	n	131	261
other race other	n	1	7
weight	mean (kg)	88.94	87.10
weight	sd (kg)	20.84	20.01
white	n	130	254

Analyses this trial contributes to

Results

27 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	change	-0.38 percent	0.107		158	while on treatment; modified itt; registry:outcomes
24	A2	change	-0.74 percent	0.090		304	while on treatment; modified itt; registry:outcomes
24	A2 vs A1	md	-0.36 percent		-0.550 to -0.174		while on treatment; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.52 kg	0.293		161	while on treatment; modified itt; registry:outcomes
24	A2	change	-1.80 kg	0.246		311	while on treatment; modified itt; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	12.0			158	while on treatment; modified itt; registry:outcomes
24	A2	responders	28.3			304	while on treatment; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 167	while on treatment; safety; registry:outcomes
	A2	events				7 / 328	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	3.1			161	while on treatment; modified itt; registry:outcomes
24	A2	responders	13.2			311	while on treatment; modified itt; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				17 / 167	while on treatment; safety; registry:adverse_events
	A2	events				46 / 328	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				12 / 167	not stated; randomized; registry:flow
	A2	events				37 / 329	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 167	while on treatment; safety; registry:adverse_events
	A2	events				96 / 328	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				2 / 167	while on treatment; safety; registry:adverse_events
	A2	events				32 / 328	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				10 / 167	while on treatment; safety; registry:adverse_events
	A2	events				37 / 328	while on treatment; safety; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 167	while on treatment; safety; pancreatitis; registry:adverse_events
	A2	events				1 / 328	while on treatment; safety; pancreatitis; registry:adverse_events

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 167	while on treatment; safety; retinopathy haemorrhagic; registry:adverse_events
	A2	events				1 / 328	while on treatment; safety; retinopathy haemorrhagic; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 167	while on treatment; safety; pancreatic carcinoma; registry:adverse_events
	A2	events				1 / 328	while on treatment; safety; pancreatic carcinoma; registry:adverse_events