parallel randomized trial

S002951

Design

Randomized: 156
Start year: 2022
Treatment: 16 weeks, follow-up 16 weeks
Countries: China (1 sites)
Sponsor: China International Medical Foundation (non industry)
Eligibility: age 18 to 65; BMI 25 or more; HbA1c 7.0 to 10.0 percent; lifestyle or one OAD

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Polyethylene glycol loxenatide 0.3 mg injection once weekly PEG-Loxe	lifestyle or one stable oral drug; sulfonylurea or glinide reduced if HbA1c below 7.5; lifestyle: not reported	104	104
A2	Metformin Metformin	lifestyle or one stable oral drug; sulfonylurea or glinide reduced if HbA1c below 7.5; lifestyle: not reported	52	52

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

Characteristic	Statistic	Polyethylene glycol loxenatide 0.3 mg injection once weekly A1	Metformin A2
age	mean (years)	40.3	42.2
age	sd (years)	10.0	9.5
bmi	mean (kg/m2)	30.0	30.1
bmi	sd (kg/m2)	3.6	3.5
diabetes duration	mean (years)	2.1	2.1
diabetes duration	sd (years)	1.7	1.5
female	n	37	20
female	percent	35.6	38.5
hba1c	mean (percent)	8.79	8.68
hba1c	sd (percent)	0.83	0.95
other background lifestyle only	n	83	43
other background lifestyle only	percent	79.8	82.7
other background oad	n	21	9
other background oad	percent	20.2	17.3
sbp	median (mmHg)	132.0	134.0
sbp	q1 (mmHg)	136.0	128.0
sbp	q3 (mmHg)	138.8	136.0
waist	mean (cm)	102.1	104.6
waist	sd (cm)	14.6	16.9
weight	mean (kg)	87.6	87.9
weight	sd (kg)	13.9	13.7

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1 vs A2	md	-0.05 percent	-0.28 to 0.19		not stated; full analysis; R0007588:Table 2
16	A1	change	-1.22 percent	-1.38 to -1.06	104	not stated; full analysis; R0007588:Table 2
16	A2	change	-1.17 percent	-1.39 to -0.96	52	not stated; full analysis; R0007588:Table 2

Body weight change in kilograms (diabetes) (6 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1 vs A2	md	-4.73 kg	-5.52 to -3.94		not stated; per protocol; R0007588:Supplement Table S1
16	A1	change	-7.50 kg	-8.02 to -6.98	92	not stated; per protocol; R0007588:Supplement Table S1
16	A1	change	-7.52 kg	-8.21 to -6.82	104	not stated; full analysis; R0007588:Table 2
16	A1 vs A2	md	-4.55 kg	-5.67 to -3.43		not stated; full analysis; R0007588:Table 2
16	A2	change	-2.96 kg	-3.92 to -2.00	52	not stated; full analysis; R0007588:Table 2
16	A2	change	-2.77 kg	-3.47 to -2.08	47	not stated; per protocol; R0007588:Supplement Table S1

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 104	not stated; safety; R0007588:Table 3
A1	events	0 / 104	not stated; safety; R0007588:Table 3
A1	events	3 / 104	not stated; safety; R0007588:Table 3
A2	events	0 / 52	not stated; safety; R0007588:Table 3
A2	events	2 / 52	not stated; safety; R0007588:Table 3
A2	events	1 / 52	not stated; safety; R0007588:Table 3

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	change	-3.18 mmHg	-3.78 to -2.58	104	not stated; full analysis; R0007588:Table 2
16	A1 vs A2	md	-2.90 mmHg	-3.77 to -2.03		not stated; full analysis; R0007588:Table 2
16	A2	change	-0.28 mmHg	-1.06 to 0.51	52	not stated; full analysis; R0007588:Table 2

Percent body weight change (6 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1 vs A2	md	-5.56 percent	-6.46 to -4.66		not stated; per protocol; R0007588:Supplement Table S1
16	A1	percent change	-8.37 percent	-9.20 to -7.55	104	not stated; full analysis; R0007588:Table 2
16	A1	percent change	-8.36 percent	-8.97 to -7.74	92	not stated; per protocol; R0007588:Supplement Table S1
16	A1 vs A2	md	-5.38 percent	-6.68 to -4.07		not stated; full analysis; R0007588:Table 2
16	A2	percent change	-3.00 percent	-4.13 to -1.86	52	not stated; full analysis; R0007588:Table 2
16	A2	percent change	-2.80 percent	-3.61 to -1.98	47	not stated; per protocol; R0007588:Supplement Table S1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	responders	61.5			104	not stated; full analysis; R0007588:Results
16	A2	responders	25.0			52	not stated; full analysis; R0007588:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	responders	26.9			104	not stated; full analysis; R0007588:Results
16	A2	responders	5.8			52	not stated; full analysis; R0007588:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 104	not stated; safety; R0007588:Table 3
	A2	events				0 / 52	not stated; safety; R0007588:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 104	not stated; safety; R0007588:Table 3
	A2	events				1 / 52	not stated; safety; R0007588:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 104	not stated; safety; R0007588:Table 3
	A2	events				3 / 52	not stated; safety; R0007588:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 104	not stated; safety; R0007588:Table 3
	A2	events				4 / 52	not stated; safety; R0007588:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 104	not stated; safety; R0007588:Table 3
	A2	events				1 / 52	not stated; safety; R0007588:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 104	not stated; safety; R0007588:Table 3
	A2	events				2 / 52	not stated; safety; R0007588:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 104	not stated; safety; R0007588:Results
	A2	events				0 / 52	not stated; safety; R0007588:Results