parallel randomized trial

S003047

Design

Randomized: 120
Start year: 2006
Treatment: 6 weeks, follow-up 6.57 weeks
Countries: Australia, Germany, Japan, South Africa, Netherlands (30 sites)
Sponsor: Sanofi (industry)
Eligibility: age 20 to 75; HbA1c 7.0 to 10.0 percent; BMI 35 or less; sulfonylurea with or without metformin

Arm	Treatment	Background	Analyzed	Completed treatment
A1	Lixisenatide 30 µg injection once daily Lixisenatide QD	sulfonylurea with or without metformin; lifestyle: not reported	34	39
A2	Lixisenatide 30 µg injection twice daily Lixisenatide BID	sulfonylurea with or without metformin; lifestyle: not reported	37	39
A3	Placebo Placebo	sulfonylurea with or without metformin; lifestyle: not reported	39	39

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Lixisenatide 30 µg injection once daily A1	Lixisenatide 30 µg injection twice daily A2	Placebo A3
age	max (years)	74.0	75.0	73.0
age	median (years)	62.0	64.0	62.5
age	min (years)	44.0	47.0	36.0
asian: japanese	n	20	22	21
bmi	mean (kg/m2)	25.1	27.5	26.4
bmi	sd (kg/m2)	3.7	4.4	3.5
diabetes duration	max (years)	26.8	45.3	21.4
diabetes duration	median (years)	10.4	7.4	8.4
diabetes duration	min (years)	2.5	1.2	1.4
hba1c: 8.5 or more	n	13	21	17
hba1c: 8.5 or more	percent	33.3	51.2	42.5
hba1c: less than 8.5	n	26	20	23
hba1c: less than 8.5	percent	66.7	48.8	57.5
hba1c	mean (percent)	8.17	8.49	8.39
hba1c	sd (percent)	0.75	0.85	0.75
other background: sulfonylurea and metformin	n	25	22	22
other background: sulfonylurea and metformin	percent	64.1	53.7	55.0
other background: sulfonylurea only	n	14	19	18
other background: sulfonylurea only	percent	35.9	46.3	45.0
other male	n	28	32	34
other male	percent	71.8	78.0	85.0
other race asian japanese	n	20	22	21
weight	mean (kg)	72.51	79.06	76.29
weight	sd (kg)	17.37	16.89	15.78
white	n	19	19	19

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

HbA1c change (15 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
6	A1 vs A3	md	-0.31 percent		-0.573 to -0.043		not stated; per protocol; ethnicity:caucasian; R0016337:Results
6	A1 vs A3	md	-0.53 percent	0.09			not stated; per protocol; R0016337:Results
6	A1	change	-0.94 percent	0.07		34	not stated; per protocol; R0016337:Table 2
6	A1	change	-1.13 percent	0.10			not stated; per protocol; ethnicity:japanese; R0016337:Table 2
6	A1 vs A3	md	-0.76 percent		-1.012 to -0.505		not stated; per protocol; ethnicity:japanese; R0016337:Results
6	A1	change	-0.75 percent	0.10			not stated; per protocol; ethnicity:caucasian; R0016337:Table 2
6	A2	change	-1.00 percent	0.10			not stated; per protocol; ethnicity:caucasian; R0016337:Table 2
6	A2	change	-1.13 percent	0.07		37	not stated; per protocol; R0016337:Table 2
6	A2 vs A3	md	-0.72 percent	0.09			not stated; per protocol; R0016337:Results
6	A2 vs A3	md	-0.56 percent		-0.820 to -0.293		not stated; per protocol; ethnicity:caucasian; R0016337:Results
6	A2	change	-1.26 percent	0.09			not stated; per protocol; ethnicity:japanese; R0016337:Table 2
6	A2 vs A3	md	-0.89 percent		-1.133 to -0.648		not stated; per protocol; ethnicity:japanese; R0016337:Results
6	A3	change	-0.37 percent	0.09			not stated; per protocol; ethnicity:japanese; R0016337:Table 2
6	A3	change	-0.44 percent	0.10			not stated; per protocol; ethnicity:caucasian; R0016337:Table 2
6	A3	change	-0.41 percent	0.07		39	not stated; per protocol; R0016337:Table 2

Body weight change in kilograms (diabetes) (15 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
6	A1	change	-0.95 kg	0.33		34	not stated; per protocol; R0016337:Table 2
6	A1 vs A3	md	-0.59 kg	0.43			not stated; per protocol; R0016337:Results
6	A1	change	-1.20 kg	0.46			not stated; per protocol; ethnicity:caucasian; R0016337:Table 2
6	A1 vs A3	md	-1.54 kg		-2.749 to -0.330		not stated; per protocol; ethnicity:caucasian; R0016337:Results
6	A1	change	-0.70 kg	0.50			not stated; per protocol; ethnicity:japanese; R0016337:Table 2
6	A1 vs A3	md	0.36 kg		-0.819 to 1.534		not stated; per protocol; ethnicity:japanese; R0016337:Results
6	A2	change	-0.72 kg	0.42			not stated; per protocol; ethnicity:japanese; R0016337:Table 2
6	A2	change	-0.98 kg	0.48			not stated; per protocol; ethnicity:caucasian; R0016337:Table 2
6	A2 vs A3	md	-1.32 kg		-2.526 to -0.111		not stated; per protocol; ethnicity:caucasian; R0016337:Results
6	A2 vs A3	md	0.34 kg		-0.787 to 1.458		not stated; per protocol; ethnicity:japanese; R0016337:Results
6	A2	change	-0.85 kg	0.32		37	not stated; per protocol; R0016337:Table 2
6	A2 vs A3	md	-0.49 kg	0.42			not stated; per protocol; R0016337:Results
6	A3	change	0.34 kg	0.46			not stated; per protocol; ethnicity:caucasian; R0016337:Table 2
6	A3	change	-1.06 kg	0.42			not stated; per protocol; ethnicity:japanese; R0016337:Table 2
6	A3	change	-0.36 kg	0.31		39	not stated; per protocol; R0016337:Table 2

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

Arm	Statistic	Events / N	Detail
A1	events	8 / 39	not stated; safety; R0016337:Table 3
A1	events	0 / 39	not stated; safety; R0016337:Results
A2	events	0 / 41	not stated; safety; R0016337:Results
A2	events	9 / 41	not stated; safety; R0016337:Table 3
A3	events	0 / 40	not stated; safety; R0016337:Results
A3	events	3 / 40	not stated; safety; R0016337:Table 3

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				0 / 40	not stated; safety; R0016337:Supplement Table S1

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; R0016337:Results
A2	events	0 / 41	not stated; safety; R0016337:Results
A3	events	0 / 40	not stated; safety; R0016337:Results

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 39	not stated; safety; R0016337:Table 3

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; R0016337:Table 3
A2	events	1 / 41	not stated; safety; R0016337:Table 3
A3	events	1 / 40	not stated; safety; R0016337:Table 3

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; R0016337:Table 3
A2	events	2 / 41	not stated; safety; R0016337:Table 3
A3	events	1 / 40	not stated; safety; R0016337:Table 3

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	16 / 39	not stated; safety; R0016337:Table 3
A2	events	8 / 41	not stated; safety; R0016337:Table 3
A3	events	1 / 40	not stated; safety; R0016337:Table 3

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	5 / 39	not stated; safety; R0016337:Table 3
A2	events	6 / 41	not stated; safety; R0016337:Table 3
A3	events	0 / 40	not stated; safety; R0016337:Table 3

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 39	not stated; safety; R0016337:Table 3
A2	events	9 / 41	not stated; safety; R0016337:Table 3
A3	events	5 / 40	not stated; safety; R0016337:Table 3

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; R0016337:Results
A1	events	0 / 39	not stated; safety; R0016337:Table 3
A2	events	0 / 41	not stated; safety; R0016337:Results
A3	events	0 / 40	not stated; safety; R0016337:Results

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; pancreatitis; R0016337:Results
A2	events	0 / 41	not stated; safety; pancreatitis; R0016337:Results
A3	events	0 / 40	not stated; safety; pancreatitis; R0016337:Results

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; R0016337:Results
A2	events	0 / 41	not stated; safety; R0016337:Results
A3	events	0 / 40	not stated; safety; R0016337:Results