parallel randomized trial

GETGOAL-MONO

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents

Type 2 diabetes (adults)NCT00688701S002333

Design

Randomized: 361
Start year: 2008
Treatment: 12 weeks, follow-up 12.43 weeks
Countries: multinational (61 sites)
Sponsor: sanofi-aventis (industry)
Eligibility: age 20 to 85; HbA1c 7.0 to 10.0 percent; no glucose lowering drug for 3 months

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo combined (2 step and 1 step)	lifestyle: standard		121
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 2 step dose increase	lifestyle: standard	120	120	110
A3	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 1 step dose increase	lifestyle: standard	119	118	108

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	Lixisenatide 20 ug subcutaneous once daily A3
age	mean (years)	54.1	53.3	53.8
age	sd (years)	11.0	9.7	10.9
asian	n	24	27	29
asian	percent	19.7	22.5	24.4
black	n	3	0	3
black	percent	2.5		2.5
bmi	mean (kg/m2)	31.8	32.3	31.7
bmi	sd (kg/m2)	6.7	6.7	6.6
diabetes duration	max (years)	12.5	21.5	23.9
diabetes duration	median (years)	1.4	1.4	1.1
diabetes duration	min (years)	0.2	0.2	0.2
female	n	62	57	56
hba1c	mean (percent)	8.07	7.98	8.07
hba1c	sd (percent)	0.9	0.9	0.9
hispanic	n	31	25	22
other race other	n	5	5	2
other race other	percent	4.1	4.2	1.7
weight	mean (kg)	86.1	89.0	86.5
weight	sd (kg)	22	22	21
white	n	90	88	85
white	percent	73.8	73.3	71.4

Analyses this trial contributes to

Results

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

HbA1c change (13 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.19 percent	0.121		112	hypothetical; modified itt; registry:outcomes
12	A1	change	-0.27 percent				hypothetical; modified itt; R0022843:Figure 1A
12	A1	change	-0.19 percent				hypothetical; modified itt; R0022843:Results
12	A2	change	-0.73 percent	0.116		113	hypothetical; modified itt; registry:outcomes
12	A2 vs A1	md	-0.54 percent	0.123	-0.785 to -0.300		hypothetical; modified itt; registry:outcomes
12	A2	change	-0.77 percent				hypothetical; modified itt; R0022843:Figure 1A
12	A2 vs A1	md	-0.54 percent				hypothetical; modified itt; R0022843:Results
12	A2	change	-0.73 percent				hypothetical; modified itt; R0022843:Results
12	A3 vs A1	md	-0.66 percent	0.122	-0.903 to -0.423		hypothetical; modified itt; registry:outcomes
12	A3	change	-0.85 percent				hypothetical; modified itt; R0022843:Results
12	A3	change	-0.85 percent	0.119		114	hypothetical; modified itt; registry:outcomes
12	A3	change	-0.94 percent				hypothetical; modified itt; R0022843:Figure 1A
12	A3 vs A1	md	-0.66 percent				hypothetical; modified itt; R0022843:Results

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-1.98 kg	0.341	116	hypothetical; modified itt; registry:outcomes
12	A2	change	-1.96 kg	0.326	117	hypothetical; modified itt; registry:outcomes
12	A3	change	-1.92 kg	0.338	115	hypothetical; modified itt; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
12	A1	responders	26.8	112	hypothetical; modified itt; R0022843:Figure 1B
12	A2	responders	52.2	113	hypothetical; modified itt; R0022843:Figure 1B
12	A3	responders	46.5	114	hypothetical; modified itt; R0022843:Figure 1B

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 122	while on treatment; safety; R0022843:Results
A1	events	2 / 122	while on treatment; safety; R0022843:Table 2
A2	events	3 / 120	while on treatment; safety; R0022843:Table 2
A2	events	0 / 120	while on treatment; safety; R0022843:Results
A3	events	0 / 119	while on treatment; safety; R0022843:Results
A3	events	1 / 119	while on treatment; safety; R0022843:Table 2

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

Week	Arm	Statistic	Estimate	Events / N	Detail
12	A1	responders	17.2	116	hypothetical; modified itt; registry:outcomes
12	A2	responders	16.2	117	hypothetical; modified itt; registry:outcomes
12	A3	responders	18.3	115	hypothetical; modified itt; registry:outcomes

All cause mortality (1 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				0 / 119	while on treatment; safety; R0022843:Table 2

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				0 / 119	while on treatment; safety; R0022843:Table 2

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 122	while on treatment; safety; R0022843:Table 2
A2	events	1 / 120	while on treatment; safety; R0022843:Table 2
A3	events	0 / 119	while on treatment; safety; R0022843:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 122	while on treatment; safety; R0022843:Table 2
A2	events	5 / 120	while on treatment; safety; R0022843:Table 2
A3	events	3 / 119	while on treatment; safety; R0022843:Table 2

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	5 / 122	while on treatment; safety; R0022843:Table 2
A2	events	29 / 120	while on treatment; safety; R0022843:Table 2
A3	events	24 / 119	while on treatment; safety; R0022843:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 122	while on treatment; safety; R0022843:Table 2
A2	events	9 / 120	while on treatment; safety; R0022843:Table 2
A3	events	8 / 119	while on treatment; safety; R0022843:Table 2

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				5 / 120	while on treatment; safety; R0022843:Results
	A3	events				3 / 119	while on treatment; safety; R0022843:Results

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 122	while on treatment; safety; pancreatitis; R0022843:Results
A2	events	0 / 120	while on treatment; safety; pancreatitis; R0022843:Results
A3	events	0 / 119	while on treatment; safety; pancreatitis; R0022843:Results

Death by suicide (1 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				0 / 119	while on treatment; safety; R0022843:Table 2

Intestinal obstruction or ileus (3 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 122	while on treatment; safety; registry:adverse_events
A2	events	0 / 120	while on treatment; safety; registry:adverse_events
A3	events	0 / 119	while on treatment; safety; registry:adverse_events