parallel randomized trial

NCT06611904

Study of Endothelial Glycocalyx and Vascular Function in Patients With Type 2 Diabetes and Albuminuria After Administration of Dulaglutide and Dapagliflozin vs DPP-4 Inhibitors

Type 2 diabetes (adults)Chronic kidney disease with diabetes NCT06611904S002327

Design

Randomized: 60
Start year: 2018
Treatment: 52.14 weeks, follow-up 52.14 weeks
Countries: Greece (1 sites)
Sponsor: Attikon Hospital (non industry)
Eligibility: age 18 to 75; HbA1c 7 to 10 percent; albuminuria; eGFR above 60

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide and dapagliflozin 1.5 to 10 mg injection once weekly Dulaglutide 1.5 mg weekly plus dapagliflozin 10 mg daily	metformin and ACEi or ARB; lifestyle: not reported	30	30
A2	Dpp4 inhibitor DPP-4 inhibitor	metformin and ACEi or ARB; lifestyle: not reported	30	30

Baseline characteristics

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

Characteristic	Statistic	Dulaglutide and dapagliflozin 1.5 to 10 mg injection once weekly A1	Dpp4 inhibitor A2
age	mean (years)	59	63
age	sd (years)	7	7
bmi	mean (kg/m2)	35.2	29.7
bmi	sd (kg/m2)	7	6
diabetes duration	mean (years)		10
diabetes duration	median (years)	8
diabetes duration	q1 (years)	5
diabetes duration	q3 (years)	13
diabetes duration	sd (years)		4
egfr	mean (mL/min/1.73 m2)	91	93
egfr	sd (mL/min/1.73 m2)	9	10
female	n	4	8
female	percent	13	27
hba1c	mean (percent)	7.9	8.1
hba1c	sd (percent)	0.7	0.8
lvef	mean (percent)	56	53
lvef	sd (percent)	9	8
sbp	mean (mmHg)	139.58	131.13
sbp	sd (mmHg)	23.17	14.17
uacr	mean (mg/g)	326	345
uacr	sd (mg/g)	61	48

Analyses this trial contributes to

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52.14	A1	final	6.9 percent	0.6		30	not stated; randomized; R0018551:Table 2
52.14	A2	final	7.2 percent	0.7		30	not stated; randomized; R0018551:Table 2

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52.14	A1	final	131.30 mmHg	17.87		30	not stated; randomized; R0018551:Table 4
52.14	A2	final	133.10 mmHg	12.51		30	not stated; randomized; R0018551:Table 4