parallel randomized trial

NCT04466904

A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control

Type 2 diabetes (adults)NCT04466904S002331

Design

Randomized: 43
Start year: 2020
Treatment: 12 weeks, follow-up 20 weeks
Countries: China (9 sites)
Sponsor: Innovent Biologics (industry)
Eligibility: age 18 to 75; T2D on diet and exercise or stable metformin; HbA1c 7.5 to 11.0 percent; BMI 20 to 35

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: safety
Missing data: MMRM, no imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Mazdutide 3 mg subcutaneous once weekly IBI362 3.0 mg	diet and exercise with or without metformin; lifestyle: not reported	8	8
A2	Mazdutide 4.5 mg subcutaneous once weekly IBI362 4.5 mg	diet and exercise with or without metformin; lifestyle: not reported	8	8
A3	Mazdutide 6 mg subcutaneous once weekly IBI362 6.0 mg	diet and exercise with or without metformin; lifestyle: not reported	8	8
A4	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg open label	diet and exercise with or without metformin; lifestyle: not reported		6
A5	Placebo Pooled placebo	diet and exercise with or without metformin; lifestyle: not reported		12

Baseline characteristics

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

Characteristic	Statistic	Mazdutide 3 mg subcutaneous once weekly A1	Mazdutide 4.5 mg subcutaneous once weekly A2	Mazdutide 6 mg subcutaneous once weekly A3	Dulaglutide 1.5 mg subcutaneous once weekly A4	Placebo A5
age	mean (years)	58.6	47.9	54.6	50.7	50.2
age	sd (years)	5.3	8.9	10.6	4.8	8.5
asian	n	8	8	8	6	12
asian	percent	100	100	100	100	100
bmi	mean (kg/m2)	24.1	25.7	26.0	26.6	26.5
bmi	sd (kg/m2)	1.4	3.4	2.2	3.0	2.7
diabetes duration	median (years)	2.1	4.7	6.0	3.3	3.1
diabetes duration	q1 (years)	1.2	2.2	2.7	1.6	2.4
diabetes duration	q3 (years)	2.5	5.5	9.5	3.4	5.7
female	n	2	5	3	0	6
female	percent	25.0	62.5	37.5		50.0
hba1c	mean (percent)	8.9	8.8	8.5	8.3	8.3
hba1c	sd (percent)	0.7	1.0	1.1	1.4	0.7
metformin use	n	3	4	4	4	7
metformin use	percent	37.5	50.0	50.0	66.7	58.3
sbp	mean (mmHg)	129.9	120.8	122.1	115.8	121.3
sbp	sd (mmHg)	14.3	11.0	15.9	10.1	12.4
weight	mean (kg)	65.5	70.9	69.9	75.1	68.2
weight	sd (kg)	9.2	14.5	9.7	10.2	11.5

Analyses this trial contributes to

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1 vs A5	md	-0.59 percent		-1.52 to 0.35		not stated; modified itt; R0009340:Supplement Table S2
12	A1	change	-1.46 percent	0.43		8	not stated; modified itt; R0009340:Supplement Table S2
12	A2	change	-2.23 percent	0.43		8	not stated; modified itt; R0009340:Supplement Table S2
12	A2 vs A5	md	-1.35 percent		-2.30 to -0.41		not stated; modified itt; R0009340:Supplement Table S2
12	A3 vs A5	md	-0.79 percent		-1.71 to 0.13		not stated; modified itt; R0009340:Supplement Table S2
12	A3	change	-1.66 percent	0.41		8	not stated; modified itt; R0009340:Supplement Table S2
12	A4	change	-1.98 percent	0.48		6	not stated; modified itt; R0009340:Supplement Table S2
12	A4 vs A5	md	-1.11 percent		-2.12 to -0.10		not stated; modified itt; R0009340:Supplement Table S2
12	A5	change	-0.87 percent	0.34		12	not stated; modified itt; R0009340:Supplement Table S2

Level 2 or 3 hypoglycemia (participants) (11 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	1 / 8	not stated; safety; R0009340:Table 2
A2	events	0 / 8	not stated; safety; R0009340:Table 2
A2	events	0 / 8	not stated; safety; R0009340:Table 2
A2	events	0 / 8	not stated; safety; R0009340:Table 2
A3	events	1 / 8	not stated; safety; R0009340:Table 2
A4	events	0 / 6	not stated; safety; R0009340:Table 2
A4	events	0 / 6	not stated; safety; R0009340:Table 2
A4	events	0 / 6	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2

Percent body weight change (9 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	percent change	-0.9 percent	1.3		8	not stated; modified itt; R0009340:Supplement Table S2
12	A1 vs A5	md	0.1 percent		-2.6 to 2.8		not stated; modified itt; R0009340:Supplement Table S2
12	A2	percent change	-5.0 percent	1.3		8	not stated; modified itt; R0009340:Supplement Table S2
12	A2 vs A5	md	-4.0 percent		-6.7 to -1.2		not stated; modified itt; R0009340:Supplement Table S2
12	A3 vs A5	md	-4.4 percent		-7.0 to -1.7		not stated; modified itt; R0009340:Supplement Table S2
12	A3	percent change	-5.4 percent	1.2		8	not stated; modified itt; R0009340:Supplement Table S2
12	A4	percent change	-0.9 percent	1.4		6	not stated; modified itt; R0009340:Supplement Table S2
12	A4 vs A5	md	0.2 percent		-2.8 to 3.1		not stated; modified itt; R0009340:Supplement Table S2
12	A5	percent change	-1.1 percent	1.0		12	not stated; modified itt; R0009340:Supplement Table S2

Acute kidney injury (4 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0009340:Supplement Table S3
A2	events	0 / 8	not stated; safety; R0009340:Supplement Table S3
A4	events	0 / 6	not stated; safety; R0009340:Supplement Table S3
A5	events	0 / 12	not stated; safety; R0009340:Supplement Table S3

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A2	events	0 / 8	not stated; safety; R0009340:Table 2
A3	events	0 / 8	not stated; safety; R0009340:Table 2
A4	events	0 / 6	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2

Hospitalization for heart failure (4 lines; O23)

Arm	Statistic	Events / N	Detail
A2	events	0 / 8	not stated; safety; R0009340:Table 2
A3	events	0 / 8	not stated; safety; R0009340:Table 2
A4	events	0 / 6	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	2 / 8	not stated; safety; R0009340:Table 2
A2	events	0 / 8	not stated; safety; R0009340:Table 2
A3	events	0 / 8	not stated; safety; R0009340:Table 2
A4	events	0 / 6	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 8	not stated; safety; R0009340:Results

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 8	not stated; safety; R0009340:Table 2
A2	events	1 / 8	not stated; safety; R0009340:Table 2
A3	events	2 / 8	not stated; safety; R0009340:Table 2
A4	events	1 / 6	not stated; safety; R0009340:Table 2
A5	events	1 / 12	not stated; safety; R0009340:Table 2

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0009340:Table 2
A2	events	1 / 8	not stated; safety; R0009340:Table 2
A3	events	0 / 8	not stated; safety; R0009340:Table 2
A4	events	1 / 6	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 8	not stated; safety; R0009340:Table 2
A2	events	3 / 8	not stated; safety; R0009340:Table 2
A3	events	2 / 8	not stated; safety; R0009340:Table 2
A4	events	2 / 6	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2

Gallbladder and biliary disease (10 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 8	not stated; safety; cholecystitis; R0009340:Supplement Table S3
A1	events	1 / 8	not stated; safety; cholelithiasis; R0009340:Supplement Table S3
A2	events	0 / 8	not stated; safety; cholecystitis; R0009340:Supplement Table S3
A2	events	0 / 8	not stated; safety; cholelithiasis; R0009340:Supplement Table S3
A3	events	0 / 8	not stated; safety; cholecystitis; R0009340:Supplement Table S3
A3	events	0 / 8	not stated; safety; cholelithiasis; R0009340:Supplement Table S3
A4	events	0 / 6	not stated; safety; cholelithiasis; R0009340:Supplement Table S3
A4	events	0 / 6	not stated; safety; cholecystitis; R0009340:Supplement Table S3
A5	events	0 / 12	not stated; safety; cholelithiasis; R0009340:Supplement Table S3
A5	events	0 / 12	not stated; safety; cholecystitis; R0009340:Supplement Table S3

Acute pancreatitis (5 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; pancreatitis; R0009340:Results
A2	events	0 / 8	not stated; safety; pancreatitis; R0009340:Results
A3	events	0 / 8	not stated; safety; pancreatitis; R0009340:Results
A4	events	0 / 6	not stated; safety; pancreatitis; R0009340:Results
A5	events	0 / 12	not stated; safety; pancreatitis; R0009340:Results

Medullary thyroid carcinoma (5 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0009340:Results
A2	events	0 / 8	not stated; safety; R0009340:Results
A3	events	0 / 8	not stated; safety; R0009340:Results
A4	events	0 / 6	not stated; safety; R0009340:Results
A5	events	0 / 12	not stated; safety; R0009340:Results

Thyroid cancer (any) (5 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0009340:Results
A2	events	0 / 8	not stated; safety; R0009340:Results
A3	events	0 / 8	not stated; safety; R0009340:Results
A4	events	0 / 6	not stated; safety; R0009340:Results
A5	events	0 / 12	not stated; safety; R0009340:Results

Death by suicide (4 lines; O35B)

Arm	Statistic	Events / N	Detail
A2	events	0 / 8	not stated; safety; R0009340:Table 2
A3	events	0 / 8	not stated; safety; R0009340:Table 2
A4	events	0 / 6	not stated; safety; R0009340:Table 2
A5	events	0 / 12	not stated; safety; R0009340:Table 2

Pancreatic cancer (5 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0009340:Results
A2	events	0 / 8	not stated; safety; R0009340:Results
A3	events	0 / 8	not stated; safety; R0009340:Results
A4	events	0 / 6	not stated; safety; R0009340:Results
A5	events	0 / 12	not stated; safety; R0009340:Results

Any cancer (5 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0009340:Results
A2	events	0 / 8	not stated; safety; R0009340:Results
A3	events	0 / 8	not stated; safety; R0009340:Results
A4	events	0 / 6	not stated; safety; R0009340:Results
A5	events	0 / 12	not stated; safety; R0009340:Results