parallel randomized trial

NCT05990374

Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

Design

Randomized: 78
Start year: 2023
Treatment: 52 weeks, follow-up 52 weeks
Countries: China (1 sites)
Sponsor: Nanjing First Hospital (non industry)
Eligibility: age 18 to 70; BMI 20 to 40; HbA1c 7.0 to 11.0; drug naive or stable metformin

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Ebenatide 2 mg injection once weekly Ebenatide 2 mg weekly	metformin if already used, or none; lifestyle: standard	52	52
A2	Placebo Placebo then ebenatide	metformin if previously used; medical nutrition therapy and moderate activity; lifestyle: standard	26	24

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

Characteristic	Statistic	Ebenatide 2 mg injection once weekly A1	Placebo A2
age	mean (years)	54.92	54.33
age	sd (years)	10.27	9.63
bmi	mean (kg/m2)	25.87	27.90
bmi	sd (kg/m2)	2.70	4.03
female	n	15	6
hba1c	mean (percent)	8.48	8.06
hba1c	sd (percent)	1.13	0.76
other fpg	mean (mmol/L)	8.59	8.84
other fpg	sd (mmol/L)	1.64	1.60
sbp	mean (mmHg)	132.17	130.46
sbp	sd (mmHg)	13.34	15.93
waist	mean (cm)	92.49	93.63
waist	sd (cm)	7.35	10.38
weight	mean (kg)	72.58	78.27
weight	sd (kg)	9.94	15.23

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	7.32 percent	0.89		52	not stated; completers; R0016638:Table 3
24	A2	final	7.47 percent	0.69		24	not stated; completers; R0016638:Results
24	A2 vs A1	md	0.57 percent		0.14 to 1.04		not stated; completers; R0016638:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	71.52 kg	10.07		51	not stated; completers; R0016638:Table 5
24	A2	final	77.69 kg	15.48		24	not stated; completers; R0016638:Supplement Table 1

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	37			52	not stated; completers; R0016638:Table 2
24	A2	responders	17			24	not stated; completers; R0016638:Table 2

Level 2 or 3 hypoglycemia (participants) (1 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; completers; R0016638:Discussion

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	125.31 mmHg	10.58		52	not stated; completers; R0016638:Table 6
24	A2	final	128.87 mmHg	11.83		24	not stated; completers; R0016638:Supplement Table 1

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	9.6				not stated; completers; R0016638:Discussion

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	5.8				not stated; completers; R0016638:Discussion

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; completers; R0016638:Discussion
	A2	events				0 /	not stated; completers; R0016638:Discussion