parallel randomized trial

GETGOAL-M

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

Type 2 diabetes (adults)NCT00712673S002188

Design

Randomized: 680
Start year: 2008
Treatment: 24 weeks
Countries: multinational (133 sites)
Sponsor: Sanofi (industry)
Eligibility: type 2 diabetes on metformin 1.5 g/day or more for 3 months; HbA1c 7 to 10 percent; FPG 13.9 mmol/L or less

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide morning injection	metformin 1.5 g/day or more; lifestyle: not reported	255	255
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide evening injection	metformin 1.5 g/day or more; lifestyle: not reported	255	255
A3	Placebo Combined placebo (morning and evening)	metformin 1.5 g/day or more; lifestyle: not reported		170

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	Lixisenatide 20 ug subcutaneous once daily A2	Placebo A3
age	mean (years)	54.5	54.8	55.0
age	sd (years)	9.2	10.4	9.4
asian	n	22	20	11
asian	percent	8.6	7.8	6.5
black	n	7	6	4
black	percent	2.7	2.4	2.4
bmi	mean (kg/m2)	33.2	32.5	33.1
bmi	sd (kg/m2)	6.9	5.8	6.5
diabetes duration	mean (years)	6.2	6.2	5.9
diabetes duration	sd (years)	5.3	5.4	4.7
female	n	157	141	89
female	percent	61.6	55.3	52.4
hba1c	mean (percent)	8.0	8.1	8.1
hba1c	sd (percent)	0.9	0.9	0.9
hispanic	n	96	98	49
other metformin dose	mean (mg/day)	1969	1943	2001
other metformin dose	sd (mg/day)	447	406	440
other race other	n	5	1	0
other race other	percent	2.0	0.4	0
weight	mean (kg)	90.1	89.0	90.4
weight	sd (kg)	21.0	20.7	20.1
white	n	221	228	155
white	percent	86.7	89.4	91.2

Analyses this trial contributes to

Results

90 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 vs A3	md	-0.5 percent	0.09	-0.66 to -0.31		hypothetical; modified itt; R0025872:Results
24	A1	change	-0.9 percent	0.07		244	hypothetical; modified itt; R0025872:Results
24	A2 vs A3	md	-0.4 percent	0.09	-0.54 to -0.19		hypothetical; modified itt; R0025872:Results
24	A2	change	-0.8 percent	0.07		239	hypothetical; modified itt; R0025872:Results
24	A3	change	-0.4 percent	0.08		164	hypothetical; modified itt; R0025872:Results

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-2.0 kg	0.23	248	hypothetical; modified itt; R0025872:Results
24	A2	change	-2.0 kg	0.24	249	hypothetical; modified itt; R0025872:Results
24	A3	change	-1.6 kg	0.27	168	hypothetical; modified itt; R0025872:Results

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	responders	43	244	hypothetical; modified itt; R0025872:Results
24	A2	responders	40.6	239	hypothetical; modified itt; R0025872:Results
24	A3	responders	22	164	hypothetical; modified itt; R0025872:Results

Level 2 or 3 hypoglycemia (participants) (12 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	not stated; safety; R0025872:Table 2
A1	events	0 / 255	while on treatment; safety; registry:outcomes
A1	events	18 / 255	while on treatment; safety; registry:outcomes
A1	events	6 / 255	not stated; safety; R0025872:Table 2
A2	events	0 / 255	while on treatment; safety; registry:outcomes
A2	events	13 / 255	not stated; safety; R0025872:Table 2
A2	events	22 / 255	while on treatment; safety; registry:outcomes
A2	events	0 / 255	not stated; safety; R0025872:Table 2
A3	events	4 / 170	while on treatment; safety; registry:outcomes
A3	events	0 / 170	not stated; safety; R0025872:Table 2
A3	events	0 / 170	while on treatment; safety; registry:outcomes
A3	events	1 / 170	not stated; safety; R0025872:Table 2

Weight loss of 5 percent or more (3 lines; O11A)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	responders	14.9	248	hypothetical; modified itt; registry:outcomes
24	A2	responders	19.3	249	hypothetical; modified itt; registry:outcomes
24	A3	responders	11.3	168	hypothetical; modified itt; registry:outcomes

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	not stated; safety; R0025872:Table 2
A2	events	0 / 255	not stated; safety; R0025872:Table 2
A3	events	0 / 170	not stated; safety; R0025872:Table 2

Hospitalization for heart failure (3 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	while on treatment; safety; cardiac failure congestive; registry:adverse_events
A2	events	1 / 255	while on treatment; safety; cardiac failure congestive; registry:adverse_events
A3	events	1 / 170	while on treatment; safety; cardiac failure congestive; registry:adverse_events

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	21 / 255	while on treatment; safety; registry:adverse_events
A1	events	5 / 255	not stated; safety; R0025872:Table 2
A2	events	8 / 255	not stated; safety; R0025872:Table 2
A2	events	26 / 255	while on treatment; safety; registry:adverse_events
A3	events	2 / 170	not stated; safety; R0025872:Table 2
A3	events	11 / 170	while on treatment; safety; registry:adverse_events

Discontinuation due to adverse events (7 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	21 / 255	not stated; randomized; registry:flow
A1	events	18 / 255	not stated; safety; R0025872:Table 2
A2	events	26 / 255	not stated; randomized; registry:flow
A2	events	14 / 255	not stated; safety; R0025872:Table 2
A3	events	2 / 170	not stated; safety; R0025872:Table 2
A3	events	3 / 85	not stated; randomized; group:placebo_morning; registry:flow
A3	events	3 / 85	not stated; randomized; group:placebo_evening; registry:flow

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	58 / 255	not stated; safety; R0025872:Table 2
A1	events	64 / 255	while on treatment; safety; registry:adverse_events
A2	events	54 / 255	not stated; safety; R0025872:Table 2
A2	events	63 / 255	while on treatment; safety; registry:adverse_events
A3	events	13 / 170	not stated; safety; R0025872:Table 2
A3	events	16 / 170	while on treatment; safety; registry:adverse_events

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	35 / 255	while on treatment; safety; registry:adverse_events
A1	events	24 / 255	not stated; safety; R0025872:Table 2
A2	events	34 / 255	not stated; safety; R0025872:Table 2
A2	events	40 / 255	while on treatment; safety; registry:adverse_events
A3	events	5 / 170	not stated; safety; R0025872:Table 2
A3	events	9 / 170	while on treatment; safety; registry:adverse_events

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	27 / 255	not stated; safety; R0025872:Table 2
A1	events	39 / 255	while on treatment; safety; registry:adverse_events
A2	events	27 / 255	not stated; safety; R0025872:Table 2
A2	events	36 / 255	while on treatment; safety; registry:adverse_events
A3	events	15 / 170	not stated; safety; R0025872:Table 2
A3	events	20 / 170	while on treatment; safety; registry:adverse_events

Gallbladder and biliary disease (9 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	while on treatment; safety; cholecystitis acute; registry:adverse_events
A1	events	0 / 255	while on treatment; safety; cholelithiasis; registry:adverse_events
A1	events	1 / 255	while on treatment; safety; cholecystitis; registry:adverse_events
A2	events	0 / 255	while on treatment; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 255	while on treatment; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 255	while on treatment; safety; cholecystitis; registry:adverse_events
A3	events	0 / 170	while on treatment; safety; cholecystitis; registry:adverse_events
A3	events	1 / 170	while on treatment; safety; cholecystitis acute; registry:adverse_events
A3	events	1 / 170	while on treatment; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	not stated; safety; pancreatitis; R0025872:Results
A2	events	0 / 255	not stated; safety; pancreatitis; R0025872:Results
A3	events	0 / 170	not stated; safety; pancreatitis; R0025872:Results

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	not stated; safety; R0025872:Results
A2	events	0 / 255	not stated; safety; R0025872:Results
A3	events	0 / 170	not stated; safety; R0025872:Results

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	not stated; safety; R0025872:Results
A2	events	0 / 255	not stated; safety; R0025872:Results
A3	events	0 / 170	not stated; safety; R0025872:Results

Suicidal ideation or behavior (3 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 255	while on treatment; safety; suicide attempt; registry:adverse_events
A2	events	0 / 255	while on treatment; safety; suicide attempt; registry:adverse_events
A3	events	0 / 170	while on treatment; safety; suicide attempt; registry:adverse_events

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 255	not stated; safety; R0025872:Table 2
A2	events	0 / 255	not stated; safety; R0025872:Table 2
A3	events	0 / 170	not stated; safety; R0025872:Table 2

Pancreatic cancer (3 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	1 / 255	while on treatment; safety; pancreatic carcinoma; registry:adverse_events
A2	events	0 / 255	while on treatment; safety; pancreatic carcinoma; registry:adverse_events
A3	events	0 / 170	while on treatment; safety; pancreatic carcinoma; registry:adverse_events