parallel randomized trial

S002947

Type 2 diabetes (adults)S002947

Design

Randomized: 145
Start year: 2021
Treatment: 20 weeks, follow-up 25 weeks
Countries: China (21 sites)
Sponsor: Sciwind Biosciences (industry)
Eligibility: age 18 to 65; HbA1c 7.0 to 10.5 percent; BMI 20 to 35; diet or one oral agent washed out

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Ecnoglutide 0.4 mg injection once weekly Ecnoglutide 0.4 mg QW	none (diet and exercise); lifestyle: not reported	37	37
A2	Ecnoglutide 0.8 mg injection once weekly Ecnoglutide 0.8 mg QW	none (diet and exercise); lifestyle: not reported	36	36
A3	Ecnoglutide 1.2 mg injection once weekly Ecnoglutide 1.2 mg QW	none (diet and exercise); lifestyle: not reported	36	36
A4	Placebo Placebo	none (diet and exercise); lifestyle: not reported	36	36

Baseline characteristics

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

Characteristic	Statistic	Ecnoglutide 0.4 mg injection once weekly A1	Ecnoglutide 0.8 mg injection once weekly A2	Ecnoglutide 1.2 mg injection once weekly A3	Placebo A4
age	mean (years)	49.1	51.8	49.6	49.7
age	sd (years)	8.87	10.34	9.65	10.54
bmi	mean (kg/m2)	25.8	26.6	26.2	26.4
bmi	sd (kg/m2)	3.7	3.4	3.0	3.2
diabetes duration	mean (months)	46.23	57.64	45.39	40.36
diabetes duration	sd (months)	51.93	44.18	49.55	35.58
female	n	12	8	15	17
female	percent	32.4	22.2	41.7	47.2
hba1c	mean (percent)	8.45	8.65	8.67	8.44
hba1c	sd (percent)	0.64	0.76	0.75	0.67
other fpg	mean (mmol/L)	9.70	11.08	10.00	10.50
other fpg	sd (mmol/L)	1.605	1.678	1.889	1.800
other prior antihyperglycemic	n	15	23	22	19
other prior antihyperglycemic	percent	40.5	63.9	61.1	52.8
weight	mean (kg)	72.8	76.6	72.5	71.8
weight	sd (kg)	14.6	13.4	12.1	12.2

Analyses this trial contributes to

Results

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

HbA1c change (30 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	change	-1.81 percent	0.15		33	not stated; randomized; R0006482:Results
20	A1	change	-1.7951 percent	0.1439		37	not stated; randomized; R0006482:Supplement Table S1
20	A1	change	-1.8620 percent	0.1490		32	not stated; per protocol; R0006482:Supplement Table S1
20	A1 vs A4	md	-1.26 percent		-1.67 to -0.85		not stated; randomized; R0006482:Results
20	A1 vs A4	md	-1.2785 percent	0.2022	-1.6782 to -0.8788		not stated; randomized; R0006482:Supplement Table S1
20	A1 vs A4	md	-1.3487 percent		-1.7389 to -0.9586		not stated; randomized; R0006482:Supplement Table S1
20	A1 vs A4	md	-1.3519 percent		-1.7435 to -0.9604		not stated; per protocol; R0006482:Supplement Table S1
20	A1 vs A4	md	-1.3794 percent		-1.7705 to -0.9884		not stated; per protocol; R0006482:Supplement Table S1
20	A1 vs A4	md	-1.2931 percent	0.2085	-1.7057 to -0.8805		not stated; per protocol; R0006482:Supplement Table S1
20	A2	change	-1.90 percent	0.15		31	not stated; randomized; R0006482:Results
20	A2	change	-1.8188 percent	0.1500		36	not stated; randomized; R0006482:Supplement Table S1
20	A2	change	-1.9217 percent	0.1528		31	not stated; per protocol; R0006482:Supplement Table S1
20	A2 vs A4	md	-1.35 percent		-1.77 to -0.94		not stated; randomized; R0006482:Results
20	A2 vs A4	md	-1.3022 percent	0.2064	-1.7104 to -0.8940		not stated; randomized; R0006482:Supplement Table S1
20	A2 vs A4	md	-1.3642 percent		-1.7669 to -0.9615		not stated; randomized; R0006482:Supplement Table S1
20	A2 vs A4	md	-1.3650 percent		-1.7640 to -0.9660		not stated; per protocol; R0006482:Supplement Table S1
20	A2 vs A4	md	-1.3601 percent		-1.7613 to -0.9588		not stated; per protocol; R0006482:Supplement Table S1
20	A2 vs A4	md	-1.3529 percent	0.2112	-1.7708 to -0.9350		not stated; per protocol; R0006482:Supplement Table S1
20	A3	change	-2.39 percent	0.15		32	not stated; randomized; R0006482:Results
20	A3	change	-2.3319 percent	0.1434		36	not stated; randomized; R0006482:Supplement Table S1
20	A3	change	-2.3710 percent	0.1503		32	not stated; per protocol; R0006482:Supplement Table S1
20	A3 vs A4	md	-1.84 percent		-2.25 to -1.43		not stated; randomized; R0006482:Results
20	A3 vs A4	md	-1.8154 percent	0.2021	-2.2150 to -1.4157		not stated; randomized; R0006482:Supplement Table S1
20	A3 vs A4	md	-1.9025 percent		-2.2955 to -1.5094		not stated; randomized; R0006482:Supplement Table S1
20	A3 vs A4	md	-1.8481 percent		-2.2398 to -1.4563		not stated; per protocol; R0006482:Supplement Table S1
20	A3 vs A4	md	-1.9008 percent		-2.2924 to -1.5093		not stated; per protocol; R0006482:Supplement Table S1
20	A3 vs A4	md	-1.8021 percent	0.2095	-2.2166 to -1.3877		not stated; per protocol; R0006482:Supplement Table S1
20	A4	change	-0.55 percent	0.15		33	not stated; randomized; R0006482:Results
20	A4	change	-0.5166 percent	0.1428		36	not stated; randomized; R0006482:Supplement Table S1
20	A4	change	-0.5689 percent	0.1460		33	not stated; per protocol; R0006482:Supplement Table S1

Body weight change in kilograms (diabetes) (7 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
20	A1	change	-1.57 kg		35	not stated; randomized; R0006482:Figure 4
20	A1 vs A4	md	-2.07 kg	-2.93 to -1.21		not stated; randomized; R0006482:Figure 4
20	A2	change	-1.65 kg		34	not stated; randomized; R0006482:Figure 4
20	A2 vs A4	md	-2.16 kg	-3.03 to -1.29		not stated; randomized; R0006482:Figure 4
20	A3	change	-2.26 kg		33	not stated; randomized; R0006482:Figure 4
20	A3 vs A4	md	-2.77 kg	-3.64 to -1.89		not stated; randomized; R0006482:Figure 4
20	A4	change	0.50 kg		33	not stated; randomized; R0006482:Figure 4

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Detail
20	A1	responders	73	not stated; randomized; R0006482:Figure 2
20	A2	responders	68	not stated; randomized; R0006482:Figure 2
20	A3	responders	84	not stated; randomized; R0006482:Figure 2
20	A4	responders	21	not stated; randomized; R0006482:Figure 2

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0006482:Results
A2	events	0 / 36	not stated; safety; R0006482:Results
A3	events	0 / 36	not stated; safety; R0006482:Results

Systolic blood pressure change (1 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A4	change	1.6 mmHg				not stated; safety; R0006482:Results

Weight loss of 5 percent or more (4 lines; O11A)

Week	Arm	Statistic	Estimate	Detail
20	A1	responders	11	not stated; randomized; R0006482:Figure 4
20	A2	responders	21	not stated; randomized; R0006482:Figure 4
20	A3	responders	33.3	not stated; randomized; R0006482:Results
20	A4	responders	3.0	not stated; randomized; R0006482:Results

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0006482:Table 2
A2	events	0 / 36	not stated; safety; R0006482:Table 2
A3	events	0 / 36	not stated; safety; R0006482:Table 2
A4	events	0 / 36	not stated; safety; R0006482:Table 2

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0006482:Table 2
A2	events	0 / 36	not stated; safety; R0006482:Table 2
A3	events	1 / 36	not stated; safety; R0006482:Table 2
A4	events	0 / 36	not stated; safety; R0006482:Table 2

Discontinuation due to adverse events (8 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0006482:Table 2
A1	events	0 / 37	not stated; safety; R0006482:Table 2
A2	events	0 / 36	not stated; safety; R0006482:Table 2
A2	events	0 / 36	not stated; safety; R0006482:Table 2
A3	events	1 / 36	not stated; safety; R0006482:Table 2
A3	events	2 / 36	not stated; safety; R0006482:Table 2
A4	events	0 / 36	not stated; safety; R0006482:Table 2
A4	events	0 / 36	not stated; safety; R0006482:Table 2

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	2 / 37	not stated; safety; R0006482:Table 3
A2	events	4 / 36	not stated; safety; R0006482:Table 3
A3	events	7 / 36	not stated; safety; R0006482:Table 3
A4	events	1 / 36	not stated; safety; R0006482:Table 3

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 37	not stated; safety; R0006482:Table 3
A2	events	0 / 36	not stated; safety; R0006482:Table 3
A3	events	2 / 36	not stated; safety; R0006482:Table 3
A4	events	0 / 36	not stated; safety; R0006482:Table 3

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	6 / 37	not stated; safety; R0006482:Table 3
A2	events	3 / 36	not stated; safety; R0006482:Table 3
A3	events	7 / 36	not stated; safety; R0006482:Table 3
A4	events	1 / 36	not stated; safety; R0006482:Table 3

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	2 / 37	not stated; safety; R0006482:Table 3
A2	events	3 / 36	not stated; safety; R0006482:Table 3
A3	events	3 / 36	not stated; safety; R0006482:Table 3
A4	events	2 / 36	not stated; safety; R0006482:Table 3

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; nausea; R0006482:Table 2
A2	events	0 / 36	not stated; safety; nausea; R0006482:Table 2
A3	events	1 / 36	not stated; safety; nausea; R0006482:Results
A4	events	0 / 36	not stated; safety; nausea; R0006482:Table 2

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0006482:Results
A2	events	0 / 36	not stated; safety; R0006482:Results
A3	events	0 / 36	not stated; safety; R0006482:Results
A4	events	0 / 36	not stated; safety; R0006482:Results

Medullary thyroid carcinoma (4 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0006482:Results
A2	events	0 / 36	not stated; safety; R0006482:Results
A3	events	0 / 36	not stated; safety; R0006482:Results
A4	events	0 / 36	not stated; safety; R0006482:Results

Diabetic retinopathy complications (4 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	0 / 37	not stated; safety; R0006482:Results
A2	events	0 / 36	not stated; safety; R0006482:Results
A3	events	0 / 36	not stated; safety; R0006482:Results
A4	events	0 / 36	not stated; safety; R0006482:Results