parallel randomized trial

NCT06974825

A Randomized, Double-blind, Placebo and Positive Drug Parallel-controlled Phase IIa Clinical Study Protocol to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Multiple-dose BGM0504 Injection in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT06974825S001200

Design

Randomized: 67
Start year: 2023
Treatment: 18 weeks, follow-up 20 weeks
Countries: China (8 sites)
Sponsor: BrightGene Bio-Medical Technology (industry)
Eligibility: age 18 to 65; HbA1c 7.0 to 10.0 percent; BMI 19.5 to 35.0; no glucose lowering drug for 8 weeks

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	BGM0504 5 mg injection once weekly BGM0504 5 mg	diet and exercise, no glucose lowering drug; lifestyle: not reported	13	13	11
A2	BGM0504 10 mg injection once weekly BGM0504 10 mg	diet and exercise, no glucose lowering drug; lifestyle: not reported	12	11
A3	BGM0504 15 mg injection once weekly BGM0504 15 mg	diet and exercise, no glucose lowering drug; lifestyle: not reported	13	12	11
A4	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1 mg open label	diet and exercise, no glucose lowering drug; lifestyle: not reported	16	16	16
A5	Placebo Placebo pooled	diet and exercise, no glucose lowering drug; lifestyle: not reported	13	12	10

Baseline characteristics

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

Characteristic	Statistic	BGM0504 5 mg injection once weekly A1	BGM0504 10 mg injection once weekly A2	BGM0504 15 mg injection once weekly A3	Semaglutide 1.0 mg subcutaneous once weekly A4	Placebo A5
age	mean (years)	56.0	51.4	46.4	48.3	48.8
age	sd (years)	6.78	11.29	10.36	9.18	11.45
bmi	mean (kg/m2)	25.1	27.3	29.7	28.6	28.1
bmi	sd (kg/m2)	2.11	1.67	2.94	2.30	3.46
diabetes duration	mean (years)	4.7	3.9	1.8	1.9	2.4
diabetes duration	sd (years)	4.73	3.35	1.42	1.93	2.15
female	n	7	11	5	5	3
female	percent	58.3	91.7	41.7	31.3	25.0
hba1c	mean (percent)	8.3	8.1	8.3	7.8	8.0
hba1c	sd (percent)	0.83	0.85	0.99	0.97	0.82
weight	mean (kg)	68.8	69.3	84.2	79.5	78.3
weight	sd (kg)	13.00	10.57	8.55	11.42	12.07

Analyses this trial contributes to

Results

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

HbA1c change (17 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-1.72 percent		-2.31 to -1.12	13	not stated; full analysis; R0015161:Table 2
12	A1	change	-1.72 percent	0.989		13	not stated; full analysis; R0015161:Table 2
12	A1 vs A4	md	0.07 percent		-0.55 to 0.70		not stated; full analysis; R0015161:Supplement Appendix A.1
12	A1 vs A5	md	-1.82 percent		-2.83 to -0.81		not stated; full analysis; R0015161:Table 2
12	A2	change	-1.94 percent		-2.85 to -1.03	11	not stated; full analysis; R0015161:Table 2
12	A2	change	-1.94 percent	1.354		11	not stated; full analysis; R0015161:Table 2
12	A2 vs A4	md	-0.16 percent		-0.97 to 0.66		not stated; full analysis; R0015161:Supplement Appendix A.1
12	A2 vs A5	md	-2.05 percent		-3.27 to -0.82		not stated; full analysis; R0015161:Table 2
12	A3	change	-2.48 percent		-3.05 to -1.91	12	not stated; full analysis; R0015161:Table 2
12	A3	change	-2.48 percent	0.899		12	not stated; full analysis; R0015161:Table 2
12	A3 vs A4	md	-0.68 percent		-1.29 to -0.06		not stated; full analysis; R0015161:Supplement Appendix A.1
12	A3 vs A5	md	-2.56 percent		-3.58 to -1.54		not stated; full analysis; R0015161:Table 2
12	A4	change	-1.43 percent		-2.05 to -0.81	16	not stated; full analysis; R0015161:Table 2
12	A4	change	-1.43 percent	1.167		16	not stated; full analysis; R0015161:Table 2
12	A4 vs A5	md	-1.86 percent		-2.83 to -0.90		not stated; full analysis; R0015161:Table 2
12	A5	change	0.28 percent		-0.77 to 1.32	12	not stated; full analysis; R0015161:Table 2
12	A5	change	0.28 percent	1.645		12	not stated; full analysis; R0015161:Table 2

Body weight change in kilograms (diabetes) (14 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.81 kg		-2.61 to 0.99	12	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A1	change	-0.81 kg	2.84		12	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A1 vs A5	md	-0.16 kg		-2.60 to 2.28		not stated; full analysis; R0015161:Supplement Appendix A.2
12	A2	change	-4.83 kg		-7.85 to -1.80	11	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A2	change	-4.83 kg	4.50		11	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A2 vs A5	md	-4.88 kg		-8.15 to -1.61		not stated; full analysis; R0015161:Supplement Appendix A.2
12	A3	change	-8.25 kg		-10.83 to -5.68	11	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A3	change	-8.25 kg	3.83		11	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A3 vs A5	md	-7.39 kg		-10.48 to -4.29		not stated; full analysis; R0015161:Supplement Appendix A.2
12	A4	change	-2.72 kg		-4.21 to -1.23	16	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A4	change	-2.72 kg	2.80		16	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A4 vs A5	md	-1.67 kg		-3.80 to 0.45		not stated; full analysis; R0015161:Supplement Appendix A.2
12	A5	change	-0.91 kg		-2.44 to 0.62	10	not stated; full analysis; R0015161:Supplement Appendix A.2
12	A5	change	-0.91 kg	2.14		10	not stated; full analysis; R0015161:Supplement Appendix A.2

HbA1c below 7 percent (9 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
12	A1	responders		10 / 13	not stated; per protocol; R0015161:Supplement Appendix B
12	A1 vs A5	rd	60.26		not stated; per protocol; R0015161:Supplement Appendix B
12	A2	responders		9 / 11	not stated; per protocol; R0015161:Supplement Appendix B
12	A2 vs A5	rd	65.15		not stated; per protocol; R0015161:Supplement Appendix B
12	A3	responders		11 / 12	not stated; per protocol; R0015161:Supplement Appendix B
12	A3 vs A5	rd	75.00		not stated; per protocol; R0015161:Supplement Appendix B
12	A4	responders		12 / 16	not stated; per protocol; R0015161:Supplement Appendix B
12	A4 vs A5	rd	58.33		not stated; per protocol; R0015161:Supplement Appendix B
12	A5	responders		2 / 12	not stated; per protocol; R0015161:Supplement Appendix B

Level 2 or 3 hypoglycemia (participants) (5 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 13	not stated; safety; R0015161:Results
A2	events	0 / 11	not stated; safety; R0015161:Results
A3	events	0 / 12	not stated; safety; R0015161:Results
A4	events	0 / 16	not stated; safety; R0015161:Results
A5	events	0 / 12	not stated; safety; R0015161:Results

Systolic blood pressure change (14 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	1.58 mmHg		-6.37 to 9.54	12	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A1	change	1.6 mmHg	12.52		12	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A1 vs A5	md	7.30 mmHg		-0.07 to 14.66		not stated; full analysis; R0015161:Supplement Appendix A.5
12	A2	change	-9.64 mmHg		-19.94 to 0.67	11	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A2	change	-9.6 mmHg	15.34		11	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A2 vs A5	md	-3.36 mmHg		-12.84 to 6.11		not stated; full analysis; R0015161:Supplement Appendix A.5
12	A3	change	-10.73 mmHg		-20.89 to -0.56	11	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A3	change	-10.7 mmHg	15.13		11	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A3 vs A5	md	-3.98 mmHg		-14.46 to 6.49		not stated; full analysis; R0015161:Supplement Appendix A.5
12	A4	change	-5.63 mmHg		-11.48 to 0.23	16	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A4	change	-5.6 mmHg	11.00		16	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A4 vs A5	md	1.76 mmHg		-5.91 to 9.43		not stated; full analysis; R0015161:Supplement Appendix A.5
12	A5	change	-6.91 mmHg		-15.66 to 1.84	11	not stated; full analysis; R0015161:Supplement Appendix A.5
12	A5	change	-6.9 mmHg	13.02		11	not stated; full analysis; R0015161:Supplement Appendix A.5

Percent body weight change (6 lines; O10)

Week	Arm	Statistic	Estimate	Detail
12	A1 vs A4	md	2.41 percent	not stated; full analysis; R0015161:Results
12	A2 vs A4	md	-3.77 percent	not stated; full analysis; R0015161:Results
12	A2 vs A5	md	-6.58 percent	not stated; full analysis; R0015161:Results
12	A3 vs A4	md	-7.15 percent	not stated; full analysis; R0015161:Results
12	A3 vs A5	md	-9.55 percent	not stated; full analysis; R0015161:Results
12	A4 vs A5	md	-2.34 percent	not stated; full analysis; R0015161:Results

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 13	not stated; safety; R0015161:Supplement Appendix D.1
A2	events	1 / 11	not stated; safety; R0015161:Supplement Appendix D.1
A3	events	0 / 12	not stated; safety; R0015161:Supplement Appendix D.1
A4	events	0 / 16	not stated; safety; R0015161:Supplement Appendix D.1
A5	events	0 / 12	not stated; safety; R0015161:Supplement Appendix D.1

Discontinuation due to adverse events (10 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 13	not stated; safety; R0015161:Supplement Appendix D.1
A1	events	1 / 13	not stated; safety; R0015161:Supplement Appendix D.1
A2	events	0 / 11	not stated; safety; R0015161:Supplement Appendix D.1
A2	events	0 / 11	not stated; safety; R0015161:Supplement Appendix D.1
A3	events	0 / 12	not stated; safety; R0015161:Supplement Appendix D.1
A3	events	0 / 12	not stated; safety; R0015161:Supplement Appendix D.1
A4	events	0 / 16	not stated; safety; R0015161:Supplement Appendix D.1
A4	events	0 / 16	not stated; safety; R0015161:Supplement Appendix D.1
A5	events	0 / 12	not stated; safety; R0015161:Supplement Appendix D.1
A5	events	0 / 12	not stated; safety; R0015161:Supplement Appendix D.1

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	5 / 13	not stated; safety; R0015161:Results
A2	events	4 / 11	not stated; safety; R0015161:Results
A3	events	9 / 12	not stated; safety; R0015161:Results
A4	events	1 / 16	not stated; safety; R0015161:Results
A5	events	0 / 12	not stated; safety; R0015161:Results