parallel randomized trial

GetGoal-O

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen

Type 2 diabetes (adults)NCT01798706S000904

Design

Randomized: 350
Start year: 2013
Treatment: 24 weeks, follow-up 24.43 weeks
Countries: multinational
Sponsor: Sanofi (industry)
Eligibility: age 70 or older; type 2 diabetes uncontrolled on basal insulin and/or oral drugs; eGFR 30 or higher

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug daily	basal insulin and/or oral antidiabetic drugs; lifestyle: not reported	176	172
A2	Placebo Placebo	basal insulin and/or oral antidiabetic drugs; lifestyle: not reported	174	172

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	Placebo A2
age	mean (years)	74	74.4
age	sd (years)	4	3.8
asian	n	5	11
black	n	3	0
bmi	mean (kg/m2)	29.91	30.09
bmi	sd (kg/m2)	3.7	4.53
diabetes duration	mean (years)	13.63	14.63
diabetes duration	sd (years)	7.34	7.87
egfr: 30 to <60	n	50	47
egfr: 30 to <60	percent	28.4	27.0
egfr: 30 to less than 60	n	50	47
egfr: 30 to less than 60	percent	28.4	27.0
egfr: 60 or more	n	126	127
egfr: 60 or more	percent	71.6	73.0
female	n	84	84
hba1c	mean (percent)	8.04	8.05
hba1c	sd (percent)	0.72	0.69
hispanic	n	51	48
insulin dose	mean (units/day)	37.6	38.5
insulin dose	sd (units/day)	21.7	22.6
insulin use	n	54	55
insulin use	percent	30.7	32.0
metformin use	n	152	150
metformin use	percent	86.4	87.2
other race other	n	40	41
other sulfonylurea use	n	70	59
other sulfonylurea use	percent	39.8	34.3
weight	mean (kg)	80.81	80.08
weight	sd (kg)	14.54	16.76
white	n	128	122

Analyses this trial contributes to

Results

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

HbA1c change (10 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1 vs A2	md	-0.68 percent	0.278			not stated; modified itt; background:basal_insulin_egfr30to<60; R0023324:Table 3
24	A1	change	-0.57 percent	0.075		172	not stated; modified itt; registry:outcomes
24	A1 vs A2	md	-0.68 percent	0.167			not stated; modified itt; background:basal_insulin; R0023324:Results
24	A1	change	-0.50 percent	1.11		36	not stated; modified itt; background:basal_insulin_egfr>=60; R0023324:Table 3
24	A1 vs A2	md	-0.55 percent	0.219			not stated; modified itt; background:basal_insulin_egfr>=60; R0023324:Table 3
24	A1 vs A2	md	-0.64 percent		-0.81 to -0.464		not stated; modified itt; registry:outcomes
24	A1	change	-0.65 percent	0.95		17	not stated; modified itt; background:basal_insulin_egfr30to<60; R0023324:Table 3
24	A2	change	0.06 percent	0.072		172	not stated; modified itt; registry:outcomes
24	A2	change	0.17 percent	0.80		36	not stated; modified itt; background:basal_insulin_egfr>=60; R0023324:Table 3
24	A2	change	0.15 percent	0.64		19	not stated; modified itt; background:basal_insulin_egfr30to<60; R0023324:Table 3

Body weight change in kilograms (diabetes) (9 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.47 kg	0.241		174	while on treatment; modified itt; registry:outcomes
24	A1 vs A2	md	-1.32 kg		-1.862 to -0.769		while on treatment; modified itt; registry:outcomes
24	A1 vs A2	md	0.16 kg	1.549			not stated; modified itt; background:basal_insulin_egfr30to<60; R0023324:Table 3
24	A1	change	-1.31 kg	1.90		36	not stated; modified itt; background:basal_insulin_egfr>=60; R0023324:Table 3
24	A1 vs A2	md	-1.20 kg	0.465			not stated; modified itt; background:basal_insulin_egfr>=60; R0023324:Table 3
24	A1	change	-2.00 kg	4.82		17	not stated; modified itt; background:basal_insulin_egfr30to<60; R0023324:Table 3
24	A2	change	0.52 kg	2.72		19	not stated; modified itt; background:basal_insulin_egfr30to<60; R0023324:Table 3
24	A2	change	-0.16 kg	0.228		173	while on treatment; modified itt; registry:outcomes
24	A2	change	-0.05 kg	1.93		36	not stated; modified itt; background:basal_insulin_egfr>=60; R0023324:Table 3

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	0.57	176	while on treatment; safety; registry:outcomes
A1	events	7.4	176	while on treatment; safety; registry:outcomes
A2	events	0	174	while on treatment; safety; registry:outcomes
A2	events	5.7	174	while on treatment; safety; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 176	not stated; safety; Renal failure acute; registry:adverse_events
	A2	events				1 / 174	not stated; safety; Renal failure acute; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 176	not stated; safety; registry:adverse_events
	A2	events				10 / 174	not stated; 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				15 / 176	not stated; randomized; registry:flow
	A2	events				10 / 174	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				44 / 176	not stated; safety; registry:adverse_events
	A2	events				13 / 174	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 176	not stated; safety; registry:adverse_events
	A2	events				1 / 174	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				19 / 176	not stated; safety; registry:adverse_events
	A2	events				13 / 174	not stated; safety; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 176	not stated; safety; Pancreatitis; registry:adverse_events
	A2	events				1 / 174	not stated; safety; Pancreatitis; registry:adverse_events