parallel randomized trial

NCT04504396

A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

Type 2 diabetes (adults)NCT04504396S001230

Design

Randomized: 620
Start year: 2020
Treatment: 24 weeks, follow-up 56 weeks
Countries: China (71 sites)
Sponsor: PegBio Co., Ltd (industry)
Eligibility: age 18 to 75; HbA1c 7.0 to 10.5 percent; BMI 40 or lower; eGFR 60 or higher; metformin monotherapy at least 1000 mg

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, no imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Visepegenatide 150 µg injection once weekly Visepegenatide 150 ug	metformin; lifestyle: standard	310	310	287
A2	Placebo Placebo	metformin; lifestyle: standard	310	310	286

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)	52.7	53.7
age	sd (years)	10.92	10.63
bmi	mean (kg/m2)	26.67	26.28
bmi	sd (kg/m2)	3.70	3.51
diabetes duration	mean (years)	5.09	5.18
diabetes duration	sd (years)	4.65	4.47
egfr	mean (mL/min/1.73m2)	104.98	104.99
egfr	sd (mL/min/1.73m2)	14.22	13.92
established cvd: diabetic macroangiopathy	n	3	3
established cvd: diabetic macroangiopathy	percent	1.0	1.0
female	n	114	132
female	percent	36.8	42.6
hba1c	mean (percent)	8.48	8.46
hba1c	sd (percent)	0.86	0.79
other han nationality	percent	96.8	94.8
weight	mean (kg)	73.92	72.06
weight	sd (kg)	13.39	12.59

Analyses this trial contributes to

Results

29 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
24	A1 vs A2	md	-0.57 percent	-0.71 to -0.42		hypothetical; full analysis; R0009432:Table 2
24	A1	change	-1.27 percent	-1.37 to -1.16	310	hypothetical; full analysis; R0009432:Table 2
24	A1	change	-1.25 percent	-1.35 to -1.16	310	treatment policy; full analysis; R0009432:Table 2
24	A1 vs A2	md	-0.57 percent	-0.71 to -0.43		treatment policy; full analysis; R0009432:Table 2
24	A2	change	-0.70 percent	-0.80 to -0.60	310	hypothetical; full analysis; R0009432:Table 2
24	A2	change	-0.68 percent	-0.78 to -0.59	310	treatment policy; full analysis; R0009432:Table 2

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.56 kg	2.63		310	not stated; full analysis; R0009432:Results
24	A2	change	-0.67 kg	2.454		310	not stated; full analysis; R0009432:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	40.5			115 / 310	not stated; full analysis; R0009432:Table 2
24	A2	responders	17.9			50 / 310	not stated; full analysis; R0009432:Table 2

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 310	treatment policy; safety; R0009432:Results
A1	events	0 / 310	treatment policy; safety; R0009432:Table 3
A1	events	8 / 310	treatment policy; safety; R0009432:Table 3
A2	events	10 / 310	treatment policy; safety; R0009432:Table 3
A2	events	0 / 310	treatment policy; safety; R0009432:Table 3

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 310	treatment policy; safety; R0009432:Table 3
	A2	events				0 / 310	treatment policy; safety; R0009432:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 310	treatment policy; safety; R0009432:Table 3
	A2	events				12 / 310	treatment policy; safety; R0009432:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 310	treatment policy; safety; R0009432:Table 3
	A2	events				1 / 310	treatment policy; safety; R0009432:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 310	treatment policy; safety; R0009432:Table 3
	A2	events				1 / 310	treatment policy; safety; R0009432:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 310	treatment policy; safety; R0009432:Table 3
	A2	events				1 / 310	treatment policy; safety; R0009432:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				23 / 310	treatment policy; safety; R0009432:Table 3
	A2	events				15 / 310	treatment policy; safety; R0009432:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 310	treatment policy; safety; R0009432:Table 3
	A2	events				0 / 310	treatment policy; safety; R0009432:Table 3