parallel randomized trial

NCT01632163

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Type 2 diabetes (adults)NCT01632163S001963

Design

Randomized: 448
Start year: 2012
Treatment: 24 weeks, follow-up 24 weeks
Countries: China, India, Korea, Russia (51 sites)
Sponsor: Sanofi (industry)
Eligibility: adults; T2D at least 1 year; HbA1c 7 to 10.5 at screening, 7 to 9.5 after run in; basal insulin at least 15 U

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: while on treatment
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	basal insulin with or without metformin; lifestyle: not reported	224	223
A2	Placebo Placebo	basal insulin with or without metformin; lifestyle: not reported	224	223

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)	53.9	56.2
age	sd (years)	9.9	9.1
asian	n	195	190
asian	percent	87.1	84.8
bmi	mean (kg/m2)	27.5	27.9
bmi	sd (kg/m2)	4.39	4.48
diabetes duration	mean (years)	10.3	10.2
diabetes duration	sd (years)	6.1	6.2
hba1c	mean (percent)	7.9	7.9
hba1c	sd (percent)	0.66	0.70
insulin dose	mean (U/day)	39.8	37.3
insulin dose	sd (U/day)	19.0	15.9
metformin use	n	198	199
metformin use	percent	88.4	88.8
other basal insulin duration	mean (years)	2.3	2.1
other basal insulin duration	sd (years)	2.4	2.1
other insulin glargine	n	182	189
other insulin glargine	percent	81.3	84.4
other male	n	105	98
other male	percent	46.9	43.8
weight	mean (kg)	74.2	74.6
weight	sd (kg)	14.1	13.3
white	n	29	34
white	percent	12.9	15.2

Analyses this trial contributes to

Results

34 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 A2	md	-0.51 percent	0.09	-0.685 to -0.341		while on treatment; modified itt; R0014725:Results
24	A1	final	7.41 percent	1.08		223	while on treatment; modified itt; R0014725:Results
24	A1	change	-0.62 percent	0.09		223	while on treatment; modified itt; R0014725:Results
24	A2	change	-0.11 percent	0.09		223	while on treatment; modified itt; R0014725:Results
24	A2	final	7.94 percent	1.01		223	while on treatment; modified itt; R0014725:Results

Body weight change in kilograms (diabetes) (7 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.2 kg	0.2		223	while on treatment; modified itt; R0014725:Table 2
24	A1	change	-1.12 kg				while on treatment; modified itt; R0014725:Results
24	A1	final	73.1 kg	13.8		223	while on treatment; modified itt; R0014725:Table 2
24	A1 vs A2	md	-1.2 kg	0.2	-1.6 to -0.7		while on treatment; modified itt; R0014725:Table 2
24	A2	change	-0.1 kg	0.2		223	while on treatment; modified itt; R0014725:Table 2
24	A2	change	0.04 kg				while on treatment; modified itt; R0014725:Results
24	A2	final	74.6 kg	13.3		223	while on treatment; modified itt; R0014725:Table 2

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

Arm	Statistic	Events / N	Detail
A1	events	35 / 224	not stated; safety; R0014725:Results
A1	events	0 / 224	not stated; safety; R0014725:Table 3
A1	events	20 / 224	not stated; safety; R0014725:Table 3
A2	events	20 / 223	not stated; safety; R0014725:Table 3
A2	events	0 / 223	not stated; safety; R0014725:Table 3
A2	events	30 / 223	not stated; safety; R0014725:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 224	not stated; safety; R0014725:Table 3
	A2	events				0 / 223	not stated; safety; R0014725:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 224	not stated; safety; R0014725:Table 3
	A2	events				2 / 223	not stated; safety; R0014725:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 224	not stated; safety; R0014725:Table 3
	A2	events				4 / 223	not stated; safety; R0014725:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				51 / 224	not stated; safety; R0014725:Table 3
	A2	events				12 / 223	not stated; safety; R0014725:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				25 / 224	not stated; safety; R0014725:Table 3
	A2	events				2 / 223	not stated; safety; R0014725:Table 3

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	3 / 224	not stated; safety; nausea; R0014725:Table 3
A1	events	1 / 224	not stated; safety; vomiting; R0014725:Table 3
A2	events	0 / 223	not stated; safety; nausea; R0014725:Table 3
A2	events	0 / 223	not stated; safety; vomiting; R0014725:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 224	not stated; safety; R0014725:Results
	A2	events				0 / 223	not stated; safety; R0014725:Results