parallel randomized trial

NCT04965506

A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes

Design

Randomized: 252
Start year: 2021
Treatment: 20 weeks, follow-up 24 weeks
Countries: China (32 sites)
Sponsor: Innovent Biologics (industry)
Eligibility: age 18 to 75; HbA1c 7.0 to 10.5 percent; BMI 20 to under 40; diet or metformin

Arm	Treatment	Background	Randomized	Analyzed
A1	Mazdutide 3 mg subcutaneous once weekly Mazdutide 3 mg	metformin in 66 percent or diet alone; lifestyle: not reported	51	50
A2	Mazdutide 4.5 mg subcutaneous once weekly Mazdutide 4.5 mg	metformin in 66 percent or diet alone; lifestyle: not reported	49	48
A3	Mazdutide 6 mg subcutaneous once weekly Mazdutide 6 mg	metformin in 66 percent or diet alone; lifestyle: not reported	49	49
A4	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg open label	metformin in 66 percent or diet alone; lifestyle: not reported	50	50
A5	Placebo Placebo	metformin in 66 percent or diet alone; lifestyle: not reported	51	51

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)	52.5	55.1	54.4	52.8	52.6
age	sd (years)	13.4	10.7	9.8	12.7	11.1
asian	n	51	49	49	50	51
asian	percent	100	100	100	100	100
bmi	mean (kg/m2)	28.0	27.3	27.2	26.7	27.5
bmi	sd (kg/m2)	4.8	3.8	3.4	3.2	3.5
diabetes duration	median (years)	3.6	4.4	3.3	3.4	3.8
diabetes duration	q1 (years)	1.9	2.0	1.4	2.4	1.4
diabetes duration	q3 (years)	5.9	7.3	5.4	6.4	8.0
female	n	25	17	13	24	23
female	percent	49.0	34.7	26.5	48.0	45.1
hba1c	mean (percent)	8.11	8.11	7.94	7.94	8.16
hba1c	sd (percent)	0.84	0.91	0.93	0.92	0.91
metformin use	n	35	33	32	33	33
metformin use	percent	68.6	67.3	65.3	66.0	64.7
sbp	mean (mmHg)	128.5	130.5	128.9	125.6	128.7
sbp	sd (mmHg)	13.1	11.2	11.7	13.3	12.8
waist	mean (cm)	96.8	95.5	94.7	93.5	95.0
waist	sd (cm)	11.0	9.3	9.2	8.8	9.0
weight	mean (kg)	78.1	75.3	76.3	72.3	73.9
weight	sd (kg)	18.7	13.8	13.2	12.8	14.4

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
20	A1 vs A5	md	-1.44 percent	-1.84 to -1.04		not stated; modified itt; R0012443:Results
20	A2 vs A5	md	-1.70 percent	-2.09 to -1.30		not stated; modified itt; R0012443:Results
20	A3 vs A5	md	-1.58 percent	-1.98 to -1.18		not stated; modified itt; R0012443:Results
20	A4	change	-1.35 percent		50	not stated; modified itt; R0012443:Results
20	A4 vs A5	md	-1.38 percent	-1.77 to -0.98		not stated; modified itt; R0012443:Results
20	A5	change	0.03 percent		51	not stated; modified itt; R0012443:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A4	responders	60.0			50	not stated; modified itt; R0012443:Results
20	A5	responders	17.6			51	not stated; modified itt; R0012443:Results

Level 2 or 3 hypoglycemia (participants) (10 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0012443:Table 2
A1	events	0 / 51	not stated; safety; R0012443:Table 2
A2	events	0 / 49	not stated; safety; R0012443:Table 2
A2	events	0 / 49	not stated; safety; R0012443:Table 2
A3	events	1 / 49	not stated; safety; R0012443:Table 2
A3	events	0 / 49	not stated; safety; R0012443:Table 2
A4	events	0 / 50	not stated; safety; R0012443:Table 2
A4	events	0 / 50	not stated; safety; R0012443:Table 2
A5	events	1 / 51	not stated; safety; R0012443:Table 2
A5	events	0 / 51	not stated; safety; R0012443:Table 2

Percent body weight change (6 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
20	A1 vs A5	md	-2.74 percent	-4.62 to -0.86		not stated; modified itt; R0012443:Results
20	A2 vs A5	md	-3.92 percent	-5.78 to -2.06		not stated; modified itt; R0012443:Results
20	A3 vs A5	md	-5.73 percent	-7.61 to -3.85		not stated; modified itt; R0012443:Results
20	A4	percent change	-2.69 percent		50	not stated; modified itt; R0012443:Results
20	A4 vs A5	md	-1.31 percent	-3.18 to 0.55		not stated; modified itt; R0012443:Results
20	A5	percent change	-1.38 percent		51	not stated; modified itt; R0012443:Results

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A4	responders	18.0			50	not stated; modified itt; R0012443:Results
20	A5	responders	9.8			51	not stated; modified itt; R0012443:Results

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A4	responders	0			50	not stated; modified itt; R0012443:Results
20	A5	responders	0			51	not stated; modified itt; R0012443:Results

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0012443:Table 2
A2	events	0 / 49	not stated; safety; R0012443:Table 2
A3	events	3 / 49	not stated; safety; R0012443:Table 2
A4	events	4 / 50	not stated; safety; R0012443:Table 2
A5	events	4 / 51	not stated; safety; R0012443:Table 2

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0012443:Table 2
A2	events	0 / 49	not stated; safety; R0012443:Table 2
A3	events	0 / 49	not stated; safety; R0012443:Table 2
A4	events	1 / 50	not stated; safety; R0012443:Table 2
A5	events	0 / 51	not stated; safety; R0012443:Table 2

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	11 / 51	not stated; safety; R0012443:Table 2
A2	events	12 / 49	not stated; safety; R0012443:Table 2
A3	events	12 / 49	not stated; safety; R0012443:Table 2
A4	events	15 / 50	not stated; safety; R0012443:Table 2
A5	events	3 / 51	not stated; safety; R0012443:Table 2

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	6 / 51	not stated; safety; R0012443:Table 2
A2	events	7 / 49	not stated; safety; R0012443:Table 2
A3	events	8 / 49	not stated; safety; R0012443:Table 2
A4	events	7 / 50	not stated; safety; R0012443:Table 2
A5	events	1 / 51	not stated; safety; R0012443:Table 2

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	19 / 51	not stated; safety; R0012443:Table 2
A2	events	20 / 49	not stated; safety; R0012443:Table 2
A3	events	14 / 49	not stated; safety; R0012443:Table 2
A4	events	8 / 50	not stated; safety; R0012443:Table 2
A5	events	4 / 51	not stated; safety; R0012443:Table 2

Acute pancreatitis (5 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0012443:Results
A2	events	0 / 49	not stated; safety; R0012443:Results
A3	events	0 / 49	not stated; safety; R0012443:Results
A4	events	0 / 50	not stated; safety; R0012443:Results
A5	events	0 / 51	not stated; safety; R0012443:Results

Medullary thyroid carcinoma (5 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0012443:Results
A2	events	0 / 49	not stated; safety; R0012443:Results
A3	events	0 / 49	not stated; safety; R0012443:Results
A4	events	0 / 50	not stated; safety; R0012443:Results
A5	events	0 / 51	not stated; safety; R0012443:Results

Thyroid cancer (any) (5 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0012443:Results
A2	events	0 / 49	not stated; safety; R0012443:Results
A3	events	0 / 49	not stated; safety; R0012443:Results
A4	events	0 / 50	not stated; safety; R0012443:Results
A5	events	0 / 51	not stated; safety; R0012443:Results

Any cancer (5 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0012443:Results
A2	events	0 / 49	not stated; safety; R0012443:Results
A3	events	0 / 49	not stated; safety; R0012443:Results
A4	events	0 / 50	not stated; safety; R0012443:Results
A5	events	0 / 51	not stated; safety; R0012443:Results