parallel randomized trial

S002885

Design

Randomized: 25
Start year: 2019
Treatment: 12 weeks, follow-up 36 weeks
Countries: South Korea (1 sites)
Sponsor: (non industry)
Eligibility: age 20 to 75; HbA1c 7.0 or more on metformin and glimepiride; eGFR 30 or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide	metformin and glimepiride; lifestyle: standard	13	13	13
A2	Empagliflozin Empagliflozin	metformin and glimepiride; lifestyle: standard	12	11	11

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

Characteristic	Statistic	Dulaglutide 1.5 mg subcutaneous once weekly A1	Empagliflozin A2
age	mean (years)	56.3	56.9
age	sd (years)	7.7	8.7
bmi	mean (kg/m2)	27.2	27.6
bmi	sd (kg/m2)	4.3	2.8
diabetes duration	mean (years)	8.2	7.6
diabetes duration	sd (years)	5.2	3.8
egfr	mean (mL/min/1.73 m2)	95.9	91.7
egfr	sd (mL/min/1.73 m2)	23.0	16.9
hba1c: more than 9.0	n	10	8
hba1c: more than 9.0	percent	76.9	72.7
hba1c	mean (percent)	9.6	9.4
hba1c	sd (percent)	0.9	1.3
other male	n	5	7
other male	percent	38.5	63.6
sbp	mean (mmHg)	124.9	134.0
sbp	sd (mmHg)	9.8	9.6
waist	mean (cm)	95.1	97.4
waist	sd (cm)	9.6	7.6
weight	mean (kg)	71.2	76.0
weight	sd (kg)	13.5	11.8

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-1.75 percent	0.18		13	not stated; per protocol; R0003420:Table 2
12	A2	change	-1.71 percent	0.20		11	not stated; per protocol; R0003420:Table 2
12	A2 vs A1	md	0.04 percent	0.27	-0.50 to 0.59		not stated; per protocol; R0003420:Table 2
36	A1	change	-1.48 percent				not stated; other; R0003420:Results
36	A2	change	-1.84 percent				not stated; other; R0003420:Results

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.19 kg	0.39		13	not stated; per protocol; R0003420:Table 3
12	A2	change	-1.59 kg	0.42		11	not stated; per protocol; R0003420:Table 3
12	A2 vs A1	md	-1.40 kg	0.57	-2.55 to -0.25		not stated; per protocol; R0003420:Table 3

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders	54.2			13	not stated; per protocol; R0003420:Results
12	A2	responders	45.8			11	not stated; per protocol; R0003420:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 13	not stated; other; R0003420:Results
	A2	events				2 / 12	not stated; other; R0003420:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 13	not stated; safety; R0003420:Results
	A2	events				0 / 12	not stated; safety; R0003420:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 13	not stated; safety; R0003420:Results
	A2	events				0 / 12	not stated; safety; R0003420:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 13	not stated; safety; R0003420:Results
	A2	events				0 / 12	not stated; safety; R0003420:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 13	not stated; safety; R0003420:Results
	A2	events				0 / 12	not stated; safety; R0003420: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 / 13	not stated; safety; R0003420:Results
	A2	events				0 / 12	not stated; safety; R0003420:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 13	not stated; safety; R0003420:Results
	A2	events				0 / 12	not stated; safety; R0003420:Results