parallel randomized trial

GETGOAL-P

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 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

Type 2 diabetes (adults)NCT00763815S001204

Design

Randomized: 484
Start year: 2008
Treatment: 24 weeks, follow-up 132 weeks
Countries
Sponsor: Sanofi (industry)
Eligibility: type 2 diabetes on pioglitazone 30 mg or more with or without metformin; HbA1c 7 percent or more

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	pioglitazone with or without metformin; lifestyle: not reported	161	148
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug	pioglitazone with or without metformin; lifestyle: not reported	323	308

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)	55.3	56.0
age	sd (years)	9.5	9.5
asian	n	8	14
black	n	9	14
bmi	mean (kg/m2)	34.44	33.66
bmi	sd (kg/m2)	7.04	6.71
diabetes duration	mean (years)	8.09	8.11
diabetes duration	sd (years)	5.58	5.44
female	n	79	151
hba1c	mean (percent)	8.06	8.08
hba1c	sd (percent)	0.79	0.90
hispanic	n	41	87
metformin use	n	131	261
other fpg	mean (mmol/L)	9.13	9.11
other pioglitazone 45mg or more	n	35	81
other race other	n	12	22
weight	mean (kg)	96.74	92.93
weight	sd (kg)	25.58	22.90
white	n	132	273

Analyses this trial contributes to

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.34 percent	0.100		148	while on treatment; modified itt; registry:outcomes
24	A2	change	-0.90 percent	0.089		308	while on treatment; modified itt; registry:outcomes
24	A2 vs A1	md	-0.56 percent		-0.731 to -0.386		while on treatment; modified itt; registry:outcomes
24	A2 vs A1	md	-0.37 percent	0.404	-1.16 to 0.42		not stated; modified itt; asian:yes; R0021439:Table 4

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	0.21 kg	0.357		157	while on treatment; modified itt; registry:outcomes
24	A2	change	-0.21 kg	0.324		315	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	26.4			148	while on treatment; modified itt; registry:outcomes
24	A2	responders	52.3			308	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				0 / 161	while on treatment; safety; registry:outcomes
	A2	events				0 / 323	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	5.1			157	while on treatment; modified itt; registry:outcomes
24	A2	responders	9.2			315	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				15 / 161	while on treatment; safety; registry:adverse_events
	A2	events				25 / 323	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				14 / 161	not stated; randomized; registry:flow
	A2	events				29 / 323	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				22 / 161	while on treatment; safety; registry:adverse_events
	A2	events				84 / 323	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				8 / 161	while on treatment; safety; registry:adverse_events
	A2	events				26 / 323	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				23 / 161	while on treatment; safety; registry:adverse_events
	A2	events				35 / 323	while on treatment; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 161	while on treatment; safety; cholecystitis chronic; registry:adverse_events
	A2	events				1 / 323	while on treatment; safety; cholecystitis chronic; registry:adverse_events

Diabetic retinopathy complications (4 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	0 / 161	while on treatment; safety; diabetic retinopathy; registry:adverse_events
A1	events	0 / 161	while on treatment; safety; vitreous haemorrhage; registry:adverse_events
A2	events	1 / 323	while on treatment; safety; diabetic retinopathy; registry:adverse_events
A2	events	1 / 323	while on treatment; safety; vitreous haemorrhage; registry:adverse_events