parallel randomized trial

NCT01175473

An Open-label, Randomized Two-arm Parallel Group Study to Compare the Effects of 4-week QD Treatment With Lixisenatide or Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Type 2 diabetes (adults)NCT01175473S000587

Design

Randomized: 148
Start year: 2010
Treatment: 4 weeks, follow-up 4.86 weeks
Countries: Germany (7 sites)
Sponsor: Sanofi (industry)
Eligibility: age 37 to 74; HbA1c 6.5 to 9.0 percent; BMI above 20 and below 37; metformin 1.5 g/day or more

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug	metformin; lifestyle: not reported	77	75
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	metformin; lifestyle: not reported	71	68

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	Liraglutide 1.8 mg subcutaneous once daily A2
age	mean (years)	60.5	59.7
age	sd (years)	7.5	8.5
black	percent	1	0
bmi	mean (kg/m2)	31.2	31.3
bmi	sd (kg/m2)	3.9	4.1
diabetes duration	max (years)	30.8	25.6
diabetes duration	median (years)	6.7	6.7
diabetes duration	min (years)	1.1	1.1
female	percent	36	30
hba1c	mean (percent)	7.20	7.41
hba1c	sd (percent)	0.63	0.81
weight	mean (kg)	91.2	92.9
weight	sd (kg)	15.3	16.6
white	percent	99	100

Analyses this trial contributes to

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
4	A1	change	-0.32 percent		75	not stated; modified itt; R0022723:Results
4	A1	change	-0.32 percent	-0.40 to -0.24	75	not stated; modified itt; registry:outcomes
4	A2	change	-0.51 percent		68	not stated; modified itt; R0022723:Results
4	A2	change	-0.45 percent	-0.54 to -0.37	67	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
4	A1	change	-1.6 kg			75	not stated; modified itt; R0022723:Results
4	A2	change	-2.4 kg			68	not stated; modified itt; R0022723:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 77	while on treatment; safety; R0022723:Table 3
	A2	events				0 / 71	while on treatment; safety; R0022723:Table 3

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
4	A1	change	-2.0 mmHg	-4.9 to 0.8	76	not stated; safety; R0022723:Table 3
4	A1 vs A2	md	0.8 mmHg	-3.3 to 5.0		not stated; safety; R0022723:Table 3
4	A2	change	-2.8 mmHg	-5.9 to 0.2	68	not stated; safety; R0022723:Table 3

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 77	while on treatment; safety; R0022723:Table 3
	A2	events				0 / 71	while on treatment; safety; R0022723:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 77	while on treatment; safety; R0022723:Table 3
	A2	events				0 / 71	while on treatment; safety; R0022723:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 77	while on treatment; safety; R0022723:Table 3
	A2	events				2 / 71	while on treatment; safety; R0022723:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				17 / 77	while on treatment; safety; R0022723:Table 3
	A2	events				16 / 71	while on treatment; safety; R0022723:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 77	while on treatment; safety; R0022723:Table 3
	A2	events				5 / 71	while on treatment; safety; R0022723:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 77	while on treatment; safety; R0022723:Table 3
	A2	events				11 / 71	while on treatment; safety; R0022723:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 77	while on treatment; safety; registry:adverse_events
	A2	events				5 / 71	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 / 77	while on treatment; safety; R0022723:Results
	A2	events				2 / 71	while on treatment; safety; R0022723:Results