parallel randomized trial

NCT05413369

A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)

Type 2 diabetes (adults)NCT05413369S000073

Design

Randomized: 582
Start year: 2022
Treatment: 24 weeks, follow-up 24.43 weeks
Countries: China (60 sites)
Sponsor: Sanofi (industry)
Eligibility: adults 18 or older; T2D 1 year or more; HbA1c 7.5 to 11.0 percent on metformin with or without SGLT2i, or 7.0 to 10.0 percent on metformin plus another OAD; BMI below 40

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: no
Primary estimand: not stated
Analysis population: randomized
Missing data: multiple imputation; return to baseline for treatment discontinuers

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	insulin glargine and lixisenatide (iGlarLixi) iGlarLixi	metformin with or without SGLT2i; lifestyle: not reported	291	291	272
A2	Premixed insulin IDegAsp	metformin with or without SGLT2i; lifestyle: not reported	291	291	284

Baseline characteristics

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

Characteristic	Statistic	iGlarLixi A1	Premixed insulin A2
age: 50 to less than 65	n	160	153
age: 50 to less than 65	percent	55.0	52.6
age: 65 to less than 75	n	64	69
age: 65 to less than 75	percent	22.0	23.7
age: 75 or older	n	1	6
age: 75 or older	percent	0.3	2.1
age: less than 50	n	66	63
age: less than 50	percent	22.7	21.6
age	mean (years)	56.3	57.5
age	sd (years)	10.2	9.9
asian	n	291	291
bmi: 24 to less than 28	n	139	126
bmi: 24 to less than 28	percent	47.8	43.3
bmi: 28 or more	n	69	63
bmi: 28 or more	percent	23.7	21.6
bmi: less than 24	n	83	102
bmi: less than 24	percent	28.5	35.1
bmi	mean (kg/m2)	25.92	25.42
bmi	sd (kg/m2)	3.47	3.25
diabetes duration	mean (years)	8.56	9.06
diabetes duration	sd (years)	5.68	6.00
female	n	141	136
female	percent	48.5	46.7
hba1c	mean (percent)	8.58	8.53
hba1c	sd (percent)	0.93	0.90
sglt2i use	n	37	37
sglt2i use	percent	12.7	12.7
weight	mean (kg)	70.72	69.02
weight	sd (kg)	13.36	12.53

Results

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

HbA1c change (27 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1 vs A2	md	-0.20 percent		-0.33 to -0.07		not stated; randomized; R0013589:Figure 1B
24	A1 vs A2	md	-0.20 percent		-0.35 to -0.05		not stated; randomized; R0013589:Figure 1B
24	A1	final	6.58 percent	0.71		276	not stated; other; R0013589:Results
24	A1 vs A2	md	-0.29 percent		-0.51 to -0.07		not stated; randomized; diabetes_duration:10_or_more; R0008502:Figure 1
24	A1	change	-1.91 percent	0.06		191	not stated; randomized; diabetes_duration:less_than_10; R0008502:Figure 1
24	A1 vs A2	md	-0.14 percent		-0.31 to 0.03		not stated; randomized; diabetes_duration:less_than_10; R0008502:Figure 1
24	A1	change	-1.66 percent	0.12		103	not stated; randomized; hba1c:7_to_8; R0008502:Figure 1
24	A1 vs A2	md	-0.23 percent		-0.45 to 0.00		not stated; randomized; hba1c:7_to_8; R0008502:Figure 1
24	A1	change	-1.81 percent	0.08		100	not stated; randomized; hba1c:more_than_8_to_9; R0008502:Figure 1
24	A1 vs A2	md	-0.21 percent		-0.43 to 0.01		not stated; randomized; hba1c:more_than_8_to_9; R0008502:Figure 1
24	A1	change	-2.25 percent	0.15		88	not stated; randomized; hba1c:more_than_9; R0008502:Figure 1
24	A1 vs A2	md	-0.16 percent		-0.41 to 0.08		not stated; randomized; hba1c:more_than_9; R0008502:Figure 1
24	A1	change	-1.88 percent	0.05		291	not stated; randomized; R0013589:Figure 1B
24	A1	change	-1.71 percent	0.11		65	not stated; randomized; age:65_or_older; R0008502:Figure 1
24	A1 vs A2	md	-0.04 percent		-0.32 to 0.23		not stated; randomized; age:65_or_older; R0008502:Figure 1
24	A1	change	-1.94 percent	0.05		226	not stated; randomized; age:less_than_65; R0008502:Figure 1
24	A1 vs A2	md	-0.25 percent		-0.41 to -0.10		not stated; randomized; age:less_than_65; R0008502:Figure 1
24	A1	change	-1.83 percent	0.08		100	not stated; randomized; diabetes_duration:10_or_more; R0008502:Figure 1
24	A2	change	-1.68 percent	0.05		291	not stated; randomized; R0013589:Figure 1B
24	A2	change	-1.77 percent	0.06		175	not stated; randomized; diabetes_duration:less_than_10; R0008502:Figure 1
24	A2	final	6.83 percent	0.74		285	not stated; other; R0013589:Results
24	A2	change	-1.60 percent	0.08		109	not stated; randomized; hba1c:more_than_8_to_9; R0008502:Figure 1
24	A2	change	-1.54 percent	0.08		116	not stated; randomized; diabetes_duration:10_or_more; R0008502:Figure 1
24	A2	change	-1.66 percent	0.09		75	not stated; randomized; age:65_or_older; R0008502:Figure 1
24	A2	change	-2.08 percent	0.15		80	not stated; randomized; hba1c:more_than_9; R0008502:Figure 1
24	A2	change	-1.43 percent	0.12		102	not stated; randomized; hba1c:7_to_8; R0008502:Figure 1
24	A2	change	-1.69 percent	0.06		216	not stated; randomized; age:less_than_65; R0008502:Figure 1

Body weight change in kilograms (diabetes) (24 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1 vs A2	md	-1.81 kg		-3.04 to -0.58		not stated; randomized; diabetes_duration:10_or_more; R0008502:Supplement Figure S3
24	A1	change	-0.30 kg	0.29		291	not stated; randomized; R0013589:Figure 1C
24	A1 vs A2	md	-1.49 kg		-2.32 to -0.66		not stated; randomized; R0013589:Figure 1C
24	A1	change	-0.35 kg	0.59		65	not stated; randomized; age:65_or_older; R0008502:Supplement Figure S3
24	A1 vs A2	md	-1.33 kg		-2.95 to 0.30		not stated; randomized; age:65_or_older; R0008502:Supplement Figure S3
24	A1	change	-0.14 kg	0.30		226	not stated; randomized; age:less_than_65; R0008502:Supplement Figure S3
24	A1 vs A2	md	-1.55 kg		-2.35 to -0.75		not stated; randomized; age:less_than_65; R0008502:Supplement Figure S3
24	A1	change	-0.35 kg	0.50		100	not stated; randomized; diabetes_duration:10_or_more; R0008502:Supplement Figure S3
24	A1	change	-0.11 kg	0.34		191	not stated; randomized; diabetes_duration:less_than_10; R0008502:Supplement Figure S3
24	A1 vs A2	md	-1.29 kg		-2.17 to -0.41		not stated; randomized; diabetes_duration:less_than_10; R0008502:Supplement Figure S3
24	A1	change	-0.55 kg	0.94		103	not stated; randomized; hba1c:7_to_8; R0008502:Supplement Figure S3
24	A1 vs A2	md	-1.86 kg		-3.13 to -0.59		not stated; randomized; hba1c:7_to_8; R0008502:Supplement Figure S3
24	A1	change	-0.35 kg	0.59		100	not stated; randomized; hba1c:more_than_8_to_9; R0008502:Supplement Figure S3
24	A1 vs A2	md	-1.27 kg		-2.43 to -0.12		not stated; randomized; hba1c:more_than_8_to_9; R0008502:Supplement Figure S3
24	A1	change	0.39 kg	0.63		88	not stated; randomized; hba1c:more_than_9; R0008502:Supplement Figure S3
24	A1 vs A2	md	-1.37 kg		-2.71 to -0.02		not stated; randomized; hba1c:more_than_9; R0008502:Supplement Figure S3
24	A2	change	1.76 kg	0.61		80	not stated; randomized; hba1c:more_than_9; R0008502:Supplement Figure S3
24	A2	change	1.31 kg	0.93		102	not stated; randomized; hba1c:7_to_8; R0008502:Supplement Figure S3
24	A2	change	1.17 kg	0.30		175	not stated; randomized; diabetes_duration:less_than_10; R0008502:Supplement Figure S3
24	A2	change	1.46 kg	0.39		116	not stated; randomized; diabetes_duration:10_or_more; R0008502:Supplement Figure S3
24	A2	change	0.92 kg	0.54		109	not stated; randomized; hba1c:more_than_8_to_9; R0008502:Supplement Figure S3
24	A2	change	1.40 kg	0.28		216	not stated; randomized; age:less_than_65; R0008502:Supplement Figure S3
24	A2	change	1.19 kg	0.25		291	not stated; randomized; R0013589:Figure 1C
24	A2	change	0.95 kg	0.54		75	not stated; randomized; age:65_or_older; R0008502:Supplement Figure S3

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	responders	72.5		291	not stated; randomized; R0013589:Figure 2
24	A1 vs A2	or	1.89	1.25 to 2.85		not stated; randomized; R0013589:Figure 2
24	A2	responders	59.8		291	not stated; randomized; R0013589:Figure 2

Level 2 or 3 hypoglycemia (participants) (12 lines; O04)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1 vs A2	or	0.79	0.43 to 1.45		while on treatment; safety; R0013589:Table 3
A1	events			8 / 290	while on treatment; safety; R0013589:Table 3
A1 vs A2	or	0.79	0.56 to 1.11		while on treatment; safety; R0013589:Table 3
A1	events			20 / 290	while on treatment; safety; R0013589:Table 3
A1	events			0 / 290	while on treatment; safety; R0013589:Table 3
A1	events			102 / 290	while on treatment; safety; R0013589:Table 3
A1	events			22 / 290	while on treatment; safety; R0013589:Table 3
A2	events			17 / 291	while on treatment; safety; R0013589:Table 3
A2	events			25 / 291	while on treatment; safety; R0013589:Table 3
A2	events			0 / 291	while on treatment; safety; R0013589:Table 3
A2	events			118 / 291	while on treatment; safety; R0013589:Table 3
A2	events			27 / 291	while on treatment; safety; R0013589:Table 3

Level 2 or 3 hypoglycemia (episode rate) (8 lines; O04B)

Arm	Statistic	Estimate	95% CI	Detail
A1	rate			while on treatment; safety; R0013589:Table 3
A1	rate			while on treatment; safety; R0013589:Table 3
A1 vs A2	rate ratio	0.71	0.52 to 0.98	while on treatment; safety; R0013589:Table 3
A1	rate			while on treatment; safety; R0013589:Table 3
A1 vs A2	rate ratio	0.59	0.30 to 1.16	while on treatment; safety; R0013589:Table 3
A2	rate			while on treatment; safety; R0013589:Table 3
A2	rate			while on treatment; safety; R0013589:Table 3
A2	rate			while on treatment; safety; R0013589:Table 3

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 290	not stated; safety; R0013589:Results
	A2	events				0 / 291	not stated; safety; R0013589:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 290	while on treatment; safety; R0013589:Table 1
	A2	events				12 / 291	while on treatment; safety; R0013589:Table 1

Discontinuation due to adverse events (28 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 290	while on treatment; safety; sudden hearing loss; R0013589:Table 1
A1	events	2 / 290	while on treatment; safety; vomiting; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; toothache; R0013589:Table 1
A1	events	1 / 291	not stated; randomized; R0013589:Supplement Figure S2
A1	events	7 / 290	while on treatment; safety; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; abdominal distension; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; asthenia; R0013589:Table 1
A1	events	0 / 290	while on treatment; safety; cerebral infarction; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; decreased appetite; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; dizziness; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; functional gastrointestinal disorder; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; head discomfort; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; injection site hypersensitivity; R0013589:Table 1
A1	events	2 / 290	while on treatment; safety; nausea; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; dizziness; R0013589:Table 1
A2	events	1 / 291	not stated; randomized; R0013589:Supplement Figure S2
A2	events	1 / 291	while on treatment; safety; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; abdominal distension; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; asthenia; R0013589:Table 1
A2	events	1 / 291	while on treatment; safety; cerebral infarction; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; decreased appetite; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; functional gastrointestinal disorder; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; head discomfort; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; injection site hypersensitivity; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; nausea; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; sudden hearing loss; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; toothache; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; vomiting; R0013589:Table 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				35 / 290	while on treatment; safety; R0013589:Results
	A2	events				2 / 291	while on treatment; safety; R0013589:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 290	while on treatment; safety; R0013589:Results
	A2	events				0 / 291	while on treatment; safety; R0013589:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 290	while on treatment; safety; R0013589:Results
	A2	events				7 / 291	while on treatment; safety; R0013589:Results

Discontinuation due to gastrointestinal adverse events (12 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	4 / 290	while on treatment; safety; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; abdominal distension; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; functional gastrointestinal disorder; R0013589:Table 1
A1	events	2 / 290	while on treatment; safety; nausea; R0013589:Table 1
A1	events	1 / 290	while on treatment; safety; toothache; R0013589:Table 1
A1	events	2 / 290	while on treatment; safety; vomiting; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; abdominal distension; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; functional gastrointestinal disorder; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; nausea; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; toothache; R0013589:Table 1
A2	events	0 / 291	while on treatment; safety; vomiting; R0013589:Table 1

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 290	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	1 / 290	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 291	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 291	not stated; safety; cholelithiasis; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 290	not stated; safety; R0013589:Results
	A2	events				0 / 291	not stated; safety; R0013589:Results