parallel randomized trial

S002984

Design

Randomized: 78
Start year: 2020
Treatment: 24 weeks, follow-up 24 weeks
Countries: China (1 sites)
Sponsor: (mixed)
Eligibility: T2D age 45 or older; HbA1c 7.0 to 11.0 percent; metformin at least 3 months

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Polyethylene glycol loxenatide 0.2 mg subcutaneous once weekly PEG-Loxe 0.2 mg once weekly	metformin; lifestyle: not reported	39	39
A2	Insulin glargine Insulin glargine once daily	metformin; lifestyle: not reported	39	39

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

Characteristic	Statistic	Polyethylene glycol loxenatide 0.2 mg subcutaneous once weekly A1	Insulin glargine A2
age	mean (years)	68.3	67.4
age	sd (years)	10.4	10.2
bmi	mean (kg/m2)	22.7	22.6
bmi	sd (kg/m2)	3.1	2.4
diabetes duration	mean (years)	10.6	9.9
diabetes duration	sd (years)	7.6	5.7
female	n	17	22
female	percent	43.6	56.4
hba1c	mean (percent)	8.56	8.79
hba1c	sd (percent)	1.27	1.10
weight	mean (kg)	59.4	59.9
weight	sd (kg)	12.6	7.6

15 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
24	A1	change	-1.1 percent	-1.4 to -0.8	35	not stated; per protocol; R0011969:Table 2
24	A1 vs A2	md	-0.2 percent	-0.6 to 0.2		not stated; per protocol; R0011969:Table 2
24	A2	change	-0.9 percent	-1.2 to -0.6	34	not stated; per protocol; R0011969:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 39	not stated; randomized; R0011969:Results
	A2	events				1 / 39	not stated; randomized; R0011969:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 39	not stated; randomized; R0011969:Supplement Table S2
	A2	events				0 / 39	not stated; randomized; R0011969:Supplement Table S2

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; randomized; death; R0011969:Supplement Table S2
A1	events	2 / 39	not stated; randomized; other; R0011969:Supplement Table S2
A2	events	0 / 39	not stated; randomized; death; R0011969:Supplement Table S2
A2	events	3 / 39	not stated; randomized; other; R0011969:Supplement Table S2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 39	not stated; randomized; R0011969:Results
	A2	events				1 / 39	not stated; randomized; R0011969:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 39	not stated; randomized; R0011969:Supplement Table S2
	A2	events				0 / 39	not stated; randomized; R0011969:Supplement Table S2