parallel randomized trial

NCT03824002

Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study

Type 2 diabetes (adults)NCT03824002S000688

Design

Randomized
Start year: 2017
Treatment: 39.11 weeks, follow-up 39.11 weeks
Countries: Italy (1 sites)
Sponsor: University of Palermo (non industry)
Eligibility: age 50 or older; HbA1c 9.5 percent or less; up to two oral drugs with or without basal insulin

Conduct and analysis

Blinding: single blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg weekly plus conventional therapy	metformin, sulfonylurea or basal insulin plus metformin; lifestyle: standard	60	56
A2	Standard care or no added treatment Conventional therapy alone	metformin, metformin plus sulfonylurea, or basal insulin plus metformin; lifestyle: standard		56

Baseline characteristics

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	Standard care or no added treatment A2
age	mean (years)	69.7	67.6
age	sd (years)	8.6	5.1
bmi	mean (kg/m2)	27.6	27.9
bmi	sd (kg/m2)	3.4	3.2
diabetes duration	mean (years)	10.4	10.2
diabetes duration	sd (years)	3.3	4.0
egfr	mean (mL/min/1.73 m2)	77.4	76.1
egfr	sd (mL/min/1.73 m2)	11.2	16.9
female	n	32	35
female	percent	57.2	62.5
hba1c	mean (percent)	7.4	7.2
hba1c	sd (percent)	0.7	0.6
insulin use	n	12	11
insulin use	percent	21.4	19.6
metformin use	n	50	49
metformin use	percent	89.3	87.5
other sulfonylurea use	n	31	30
other sulfonylurea use	percent	55.3	53.6
other uaer: macroalbuminuria	n	4	3
other uaer: macroalbuminuria	percent	7.1	5.4
other uaer: microalbuminuria	n	12	11
other uaer: microalbuminuria	percent	21.4	19.6
other uaer	mean (mg/24 h)	80.9	73.1
other uaer	sd (mg/24 h)	20.9	29.2
sbp	mean (mmHg)	137.8	133.9
sbp	sd (mmHg)	12.1	12.3
weight	mean (kg)	75.7	76.6
weight	sd (kg)	8.5	7.5

Analyses this trial contributes to

Results

7 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
39.11	A1	final	6.2 percent	0.3		56	not stated; completers; R0017066:Table 2
39.11	A2	final	6.9 percent	0.5		56	not stated; completers; R0017066:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
39.11	A1	final	68.9 kg	5.6	56	not stated; completers; R0017066:Table 2
39.11	A1	final	68.9 kg	8.8	56	not stated; completers; R0017066:Table 3
39.11	A2	final	76.3 kg	13.8	56	not stated; completers; R0017066:Table 2

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
39.11	A1	final	129.7 mmHg	10.7		56	not stated; completers; R0017066:Table 2
39.11	A2	final	132.7 mmHg	16.7		56	not stated; completers; R0017066:Table 2