parallel randomized trial

PB119

A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

Type 2 diabetes (adults)NCT04504370S000217

Design

Randomized: 273
Start year: 2020
Treatment: 24 weeks, follow-up 56 weeks
Countries: China (30 sites)
Sponsor: PegBio Co., Ltd. (industry)
Eligibility: age 18 to 75; HbA1c 7.5 to 11.0 at screening and 7.0 to 10.5 at randomization; BMI 18.5 to 40; eGFR 60 or more; drug naive

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Visepegenatide 150 µg injection once weekly Visepegenatide 150 μg	none, diet and exercise only; lifestyle: standard	137	137	131
A2	Placebo Placebo	none, diet and exercise only; lifestyle: standard	136	136	126

Baseline characteristics

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

Characteristic	Statistic	Visepegenatide 150 µg injection once weekly A1	Placebo A2
age	mean (years)	50.3	50.4
age	sd (years)	10.25	11.41
bmi	mean (kg/m2)	26.53	26.52
bmi	sd (kg/m2)	3.51	3.73
diabetes duration	mean (years)	2.20	2.16
diabetes duration	sd (years)	2.41	2.60
egfr	mean (mL/min/1.73 m2)	105.96	107.82
egfr	sd (mL/min/1.73 m2)	13.76	14.54
female	n	33	40
female	percent	24.1	29.4
hba1c	mean (percent)	8.47	8.53
hba1c	sd (percent)	0.81	0.81
other race han	n	134	129
other race han	percent	97.8	94.9
sbp	mean (mmHg)	123.8	122.3
sbp	sd (mmHg)	11.69	11.69
weight	mean (kg)	74.34	73.71
weight	sd (kg)	12.44	13.40

Analyses this trial contributes to

Results

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

HbA1c change (29 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.37 percent		-1.53 to -1.20	137	hypothetical; full analysis; R0011471:Table 2
24	A1	change	-1.37 percent		-1.52 to -1.22	137	treatment policy; full analysis; R0011471:Supplement Table S2a
24	A1	change	-1.36 percent		-1.53 to -1.20	131	treatment policy; per protocol; R0011471:Supplement Table S1
24	A1 vs A2	md	-0.73 percent		-0.96 to -0.50		treatment policy; full analysis; R0011471:Table 2
24	A1 vs A2	md	-0.79 percent		-1.00 to -0.58		treatment policy; full analysis; R0011471:Supplement Table S2a
24	A1 vs A2	md	-0.74 percent		-0.97 to -0.51		treatment policy; per protocol; R0011471:Supplement Table S1
24	A1 vs A2	md	-0.76 percent		-0.98 to -0.55		treatment policy; full analysis; R0011471:Supplement Table S2b
24	A1 vs A2	md	-0.76 percent		-0.97 to -0.55		treatment policy; full analysis; R0011471:Supplement Table S2b
24	A1 vs A2	md	-0.75 percent		-0.96 to -0.53		treatment policy; full analysis; R0011471:Supplement Table S2b
24	A1	change	-1.59 percent	0.956			not stated; other; bmi:<24; R0011471:Supplement Table S3
24	A1	change	-1.00 percent	0.904			not stated; other; bmi:>=28; R0011471:Supplement Table S3
24	A1	change	-1.49 percent	0.899			not stated; other; bmi:24_to_<28; R0011471:Supplement Table S3
24	A1	change	-1.02 percent	0.673			not stated; other; hba1c:<=8.5; R0011471:Supplement Table S5
24	A1	change	-1.78 percent	1.059			not stated; other; hba1c:>8.5; R0011471:Supplement Table S5
24	A1	change	-1.08 percent	1.116		33	not stated; other; sex:female; R0011471:Supplement Table S4
24	A1	change	-1.44 percent	0.876		104	not stated; other; sex:male; R0011471:Supplement Table S4
24	A1 vs A2	md	-0.74 percent		-0.98 to -0.49		hypothetical; full analysis; R0011471:Table 2
24	A1	change	-1.36 percent		-1.52 to -1.20	137	treatment policy; full analysis; R0011471:Table 2
24	A2	change	-0.63 percent		-0.79 to -0.46	136	treatment policy; full analysis; R0011471:Table 2
24	A2	change	-0.58 percent		-0.73 to -0.43	136	treatment policy; full analysis; R0011471:Supplement Table S2a
24	A2	change	-0.62 percent		-0.79 to -0.46	125	treatment policy; per protocol; R0011471:Supplement Table S1
24	A2	change	-0.63 percent	0.981		40	not stated; other; sex:female; R0011471:Supplement Table S4
24	A2	change	-0.18 percent	0.891			not stated; other; bmi:<24; R0011471:Supplement Table S3
24	A2	change	-0.82 percent	0.922			not stated; other; bmi:24_to_<28; R0011471:Supplement Table S3
24	A2	change	-0.63 percent		-0.81 to -0.45	136	hypothetical; full analysis; R0011471:Table 2
24	A2	change	-0.36 percent	1.007			not stated; other; hba1c:<=8.5; R0011471:Supplement Table S5
24	A2	change	-0.77 percent	1.016			not stated; other; bmi:>=28; R0011471:Supplement Table S3
24	A2	change	-1.01 percent	0.806			not stated; other; hba1c:>8.5; R0011471:Supplement Table S5
24	A2	change	-0.66 percent	0.976		96	not stated; other; sex:male; R0011471:Supplement Table S4

Body weight change in kilograms (diabetes) (10 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Detail
24	A1	change	-1.79 kg	7.27	not stated; other; bmi:>=30; R0011471:Table 3
24	A1	change	-0.39 kg	2.56	not stated; other; bmi:24_to_<28; R0011471:Table 3
24	A1	change	0.49 kg	2.25	not stated; other; bmi:<24; R0011471:Table 3
24	A1	change	-5.13 kg	12.38	not stated; other; bmi:>=32; R0011471:Table 3
24	A1	change	-0.97 kg	5.50	not stated; other; bmi:>=28; R0011471:Table 3
24	A2	change	-1.52 kg	2.75	not stated; other; bmi:>=30; R0011471:Table 3
24	A2	change	-0.21 kg	1.80	not stated; other; bmi:<24; R0011471:Table 3
24	A2	change	-1.39 kg	2.61	not stated; other; bmi:>=28; R0011471:Table 3
24	A2	change	-1.66 kg	3.27	not stated; other; bmi:>=32; R0011471:Table 3
24	A2	change	-0.15 kg	1.96	not stated; other; bmi:24_to_<28; R0011471:Table 3

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	50.4			137	not stated; full analysis; R0011471:Table 2
24	A2	responders	14.2			136	not stated; full analysis; R0011471:Table 2

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 137	treatment policy; safety; R0011471:Results
A1	events	6 / 137	treatment policy; safety; R0011471:Table 4
A1	events	0 / 137	treatment policy; safety; R0011471:Table 4
A2	events	1 / 136	treatment policy; safety; R0011471:Table 4
A2	events	0 / 136	treatment policy; safety; R0011471:Results
A2	events	0 / 136	treatment policy; safety; R0011471:Table 4

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.5 mmHg	10.55			not stated; other; R0011471:Table 2
24	A2	change	0.3 mmHg	11.23			not stated; other; R0011471:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 137	treatment policy; safety; R0011471:Table 4
	A2	events				0 / 136	treatment policy; safety; R0011471:Table 4

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 137	treatment policy; safety; R0011471:Table 4
	A2	events				2 / 136	treatment policy; safety; R0011471:Table 4

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	5 / 137	treatment policy; safety; R0011471:Table 4
A1	events	3 / 137	treatment policy; safety; R0011471:Figure 1
A2	events	1 / 136	treatment policy; safety; R0011471:Figure 1
A2	events	1 / 136	treatment policy; safety; R0011471:Table 4

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 137	treatment policy; safety; R0011471:Table 4
	A2	events				1 / 136	treatment policy; safety; R0011471:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 137	treatment policy; safety; R0011471:Table 4
	A2	events				0 / 136	treatment policy; safety; R0011471:Table 4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 137	treatment policy; safety; R0011471:Table 4
	A2	events				2 / 136	treatment policy; safety; R0011471:Table 4

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 137	treatment policy; safety; R0011471:Table 4
	A2	events				0 / 136	treatment policy; safety; R0011471:Table 4

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 137	treatment policy; safety; R0011471:Results
	A2	events				0 / 136	treatment policy; safety; R0011471:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 137	treatment policy; safety; R0011471:Results
	A2	events				0 / 136	treatment policy; safety; R0011471:Results