parallel randomized trial

S003050

Design

Randomized: 60
Start year: 2020
Treatment: 12 weeks, follow-up 12 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: age 18 to 65; diabetes 2 years or less, no ASCVD; HbA1c 7.0 to 7.5 percent; BMI 18.5 to 30; metformin 1000 mg

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Metformin Metformin 2000 mg/day (MET)	lifestyle intervention; lifestyle: standard	30	30
A2	Dulaglutide 1.5 mg subcutaneous once weekly Metformin plus dulaglutide (MET-DUL)	metformin 1000 mg/day; lifestyle intervention; lifestyle: standard	30	29

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

Characteristic	Statistic	Metformin A1	Dulaglutide 1.5 mg subcutaneous once weekly A2
age	mean (years)	43.5	42.9
age	sd (years)	4.4	5.3
bmi	mean (kg/m2)	26.8	27.1
bmi	sd (kg/m2)	2.7	2.5
diabetes duration	mean (months)	9.3	8.8
diabetes duration	sd (months)	1.4	1.3
hba1c	mean (percent)	7.2	7.1
hba1c	sd (percent)	0.2	0.3
other male	n	17	18
other male	percent	56.7	60.0
sbp	mean (mmHg)	141.3	139.4
sbp	sd (mmHg)	14.2	12.3

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-0.39 percent		30	not stated; completers; R0021314:Table 3
12	A1	final	6.8 percent	0.2	30	not stated; completers; R0021314:Table 2
12	A2	final	6.6 percent	0.2	29	not stated; completers; R0021314:Table 2
12	A2	change	-0.48 percent		29	not stated; completers; R0021314:Table 3

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 30	not stated; safety; R0021314:Results
A1	events	0 / 30	not stated; safety; R0021314:Results
A1	events	0 / 30	not stated; safety; R0021314:Results
A2	events	0 / 30	not stated; safety; R0021314:Results
A2	events	0 / 30	not stated; safety; R0021314:Results
A2	events	0 / 30	not stated; safety; R0021314:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-1.08 mmHg		30	not stated; completers; R0021314:Table 3
12	A1	final	140.5 mmHg	15.1	30	not stated; completers; R0021314:Table 2
12	A2	change	-2.45 mmHg		29	not stated; completers; R0021314:Table 3
12	A2	final	136.8 mmHg	13.4	29	not stated; completers; R0021314:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; randomized; R0021314:Table 2
	A2	events				1 / 30	not stated; randomized; R0021314:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; randomized; R0021314:Table 2
	A2	events				1 / 30	not stated; randomized; R0021314:Results