parallel randomized trial

GetGoal-Duo1

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

Type 2 diabetes (adults)NCT00975286S000792

Design

Randomized: 446
Start year: 2009
Treatment: 24 weeks, follow-up 24 weeks
Countries: multinational (140 sites)
Sponsor: Sanofi (industry)
Eligibility: T2D on metformin 1.5 g or more with or without SU, glinide or TZD, HbA1c 7 to 10, BMI over 20; HbA1c 7 to 9 after run in

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	insulin glargine titrated plus metformin with or without TZD; lifestyle: not reported	223	223	211
A2	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug	insulin glargine titrated plus metformin with or without TZD; lifestyle: not reported	223	223	194

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	max (years)	81	80
age	mean (years)	56	56
age	min (years)	25	33
age	sd (years)	10	10
asian	n	43	44
asian	percent	19	20
black	n	11	9
black	percent	5	4
bmi: 30 or more	n	120	120
bmi: 30 or more	percent	53.8	53.8
bmi: less than 30	n	103	103
bmi: less than 30	percent	46.2	46.2
bmi	mean (kg/m2)	31.7	32.0
bmi	sd (kg/m2)	6.0	6.6
diabetes duration	mean (years)	8.7	9.6
diabetes duration	sd (years)	5.8	6.0
female	n	110	114
hba1c	mean (percent)	7.6	7.6
hba1c	sd (percent)	0.5	0.5
hispanic	n	49	52
hispanic	percent	22	23
insulin dose	mean (U/day)	44.2	43.4
insulin dose	sd (U/day)	19.9	18.9
other race other	n	2	5
other race other	percent	1	2
other tzd use	n	27	27
other tzd use	percent	12	12
weight	mean (kg)	86.8	87.3
weight	sd (kg)	20.4	21.8
white	n	167	165
white	percent	75	74

Analyses this trial contributes to

Results

56 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	final	7.3 percent	0.9		221	hypothetical; modified itt; R0026107:Table 2
24	A1	change	-0.4 percent	0.1		221	hypothetical; modified itt; R0026107:Table 2
24	A2	change	-0.7 percent	0.1		215	hypothetical; modified itt; R0026107:Table 2
24	A2	final	7.0 percent	0.8		215	hypothetical; modified itt; R0026107:Table 2
24	A2 vs A1	md	-0.3 percent		-0.5 to -0.2		hypothetical; modified itt; R0026107:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	1.2 kg	0.3		220	hypothetical; modified itt; R0026107:Table 2
24	A1	final	87.5 kg	20.7		220	hypothetical; modified itt; R0026107:Table 2
24	A2	change	0.3 kg	0.3		217	hypothetical; modified itt; R0026107:Table 2
24	A2	final	87.5 kg	22.3		217	hypothetical; modified itt; R0026107:Table 2
24	A2 vs A1	md	-0.9 kg		-1.4 to -0.4		hypothetical; modified itt; R0026107:Table 2

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders				85 / 221	hypothetical; modified itt; R0026107:Table 2
24	A2	responders				121 / 215	hypothetical; modified itt; R0026107:Table 2

Level 2 or 3 hypoglycemia (participants) (10 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		30 / 223	while on treatment; safety; registry:outcomes
A1	events		0 / 223	while on treatment; safety; registry:outcomes
A1	events		43 / 223	while on treatment; safety; registry:adverse_events
A1	events		0 / 223	while on treatment; safety; registry:adverse_events
A1	events	11.7	223	while on treatment; safety; R0026107:Results
A2	events		50 / 223	while on treatment; safety; registry:outcomes
A2	events		61 / 223	while on treatment; safety; registry:adverse_events
A2	events		1 / 223	while on treatment; safety; registry:adverse_events
A2	events		1 / 223	while on treatment; safety; R0026107:Results
A2	events	20.2	223	while on treatment; safety; R0026107:Results

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate	0.44			223	while on treatment; safety; R0026107:Results
	A2	rate	0.80			223	while on treatment; safety; R0026107:Results

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	3.2			220	hypothetical; modified itt; registry:outcomes
24	A2	responders	5.1			217	hypothetical; modified itt; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 223	while on treatment; safety; R0026107:Results
	A2	events				0 / 223	while on treatment; safety; R0026107:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 223	while on treatment; safety; cardiac failure congestive; registry:adverse_events
	A2	events				1 / 223	while on treatment; safety; cardiac failure congestive; registry:adverse_events

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	0.65 points	0.545		209	hypothetical; modified itt; registry:outcomes
24	A2	change	0.88 points	0.543		201	hypothetical; modified itt; registry:outcomes

Serious adverse events (4 lines; O25)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	4.5	223	while on treatment; safety; R0026107:Results
A1	events		10 / 223	while on treatment; safety; registry:adverse_events
A2	events	7.6	223	while on treatment; safety; R0026107:Results
A2	events		17 / 223	while on treatment; safety; registry:adverse_events

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		9 / 223	not stated; safety; registry:flow
A1	events	4.0	223	while on treatment; safety; R0026107:Results
A2	events		19 / 223	not stated; safety; registry:flow
A2	events	8.5	223	while on treatment; safety; R0026107:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 223	while on treatment; safety; registry:adverse_events
	A2	events				61 / 223	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				3 / 223	while on treatment; safety; registry:adverse_events
	A2	events				21 / 223	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				7 / 223	while on treatment; safety; registry:adverse_events
	A2	events				15 / 223	while on treatment; safety; registry:adverse_events

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 223	while on treatment; safety; R0026107:Results
	A2	events				10 / 223	while on treatment; safety; R0026107:Results

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 223	while on treatment; safety; cholecystitis acute; registry:adverse_events
	A2	events				0 / 223	while on treatment; safety; cholecystitis acute; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 223	while on treatment; safety; pancreatitis; R0026107:Results
	A2	events				0 / 223	while on treatment; safety; pancreatitis; R0026107:Results

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 223	while on treatment; safety; suicide attempt; registry:adverse_events
	A2	events				0 / 223	while on treatment; safety; suicide attempt; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 223	while on treatment; safety; R0026107:Results
	A2	events				0 / 223	while on treatment; safety; R0026107:Results