parallel randomized trial

NCT03878706

The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk

Type 2 diabetes (adults)NCT03878706S000665

Design

Randomized: 180
Start year: 2017
Treatment: 52.14 weeks, follow-up 52.14 weeks
Countries: Greece (1 sites)
Sponsor: University of Athens (non industry)
Eligibility: T2D on metformin, HbA1c above 7 percent, high or very high CV risk, eGFR 60 or more

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Basal insulin Insulin	metformin; lifestyle: not reported	40
A2	Liraglutide 1.8 mg subcutaneous once daily GLP-1RA (liraglutide)	metformin; lifestyle: not reported	40
A3	Empagliflozin SGLT-2i (empagliflozin)	metformin; lifestyle: not reported	40
A4	Liraglutide and empagliflozin 1.8 to 25 mg injection once daily Liraglutide plus empagliflozin	metformin; lifestyle: not reported	40

Baseline characteristics

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

Characteristic	Statistic	Basal insulin A1	Liraglutide 1.8 mg subcutaneous once daily A2	Empagliflozin A3	Liraglutide and empagliflozin 1.8 to 25 mg injection once daily A4
age	mean (years)	57	57	58	58
age	sd (years)	10	9	10	9
bmi	mean (kg/m2)	29.7	30	29.8	30.5
bmi	sd (kg/m2)	3	4	3	3
diabetes duration	median (years)	6.7	5.9	6.6	6.8
diabetes duration	q1 (years)	1	1	1	2
diabetes duration	q3 (years)	9	8	11	12
egfr	mean (mL/min/1.73 m2)	86	85	85	83
egfr	sd (mL/min/1.73 m2)	9	8	10	11
established cvd	n	14	13	13	14
established cvd	percent	35	32.5	32.5	35
female	n	12	13	10	10
female	percent	30	32.5	25	25
hba1c	mean (percent)	8.2	8	7.8	8.2
hba1c	sd (percent)	1.2	1.1	0.9	1.2
lvef: less than 55	n	18	19	18	19
lvef: less than 55	percent	45	47.5	45	47.5
lvef	mean (percent)	54	52	54	51
lvef	sd (percent)	7	8	8	8
metformin use	n	29	25	27	28
metformin use	percent	72.5	62.5	67.5	70
sbp	mean (mmHg)	137	137	134	139
sbp	sd (mmHg)	16	18	17	18
weight	mean (kg)	85.5	87.1	84.6	87.9
weight	sd (kg)	8	12	9	10

Analyses this trial contributes to

Results

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

HbA1c change (8 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26.07	A1	final	6.9 percent	1.0	50	not stated; completers; R0006572:Table 3
26.07	A2	final	7.0 percent	0.9	50	not stated; completers; R0006572:Table 3
26.07	A3	final	7.1 percent	1	50	not stated; completers; R0006572:Table 3
26.07	A4	final	6.4 percent	0.8	50	not stated; completers; R0006572:Table 3
52.14	A1	final	7.1 percent	1.2	40	not stated; completers; R0008057:Table 2
52.14	A2	final	6.7 percent	0.9	40	not stated; completers; R0008057:Table 2
52.14	A3	final	7.1 percent	1.1	40	not stated; completers; R0008057:Table 2
52.14	A4	final	6.4 percent	0.8	40	not stated; completers; R0008057:Table 2

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52.14	A1	final	83.5 kg	9	40	not stated; completers; R0008057:Table 2
52.14	A2	final	81.3 kg	12	40	not stated; completers; R0008057:Table 2
52.14	A3	final	80.6 kg	10	40	not stated; completers; R0008057:Table 2
52.14	A4	final	81.7 kg	9	40	not stated; completers; R0008057:Table 2

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52.14	A1	final	134 mmHg	15	40	not stated; completers; R0008057:Table 3
52.14	A2	final	135 mmHg	15	40	not stated; completers; R0008057:Table 3
52.14	A3	final	130 mmHg	15	40	not stated; completers; R0008057:Table 3
52.14	A4	final	132 mmHg	14	40	not stated; completers; R0008057:Table 3

Percent body weight change (4 lines; O10)

Week	Arm	Statistic	Estimate	Events / N	Detail
52.14	A1	percent change	-2.4 percent	40	not stated; completers; R0008057:Table 2
52.14	A2	percent change	-7.1 percent	40	not stated; completers; R0008057:Table 2
52.14	A3	percent change	-4.9 percent	40	not stated; completers; R0008057:Table 2
52.14	A4	percent change	-7.6 percent	40	not stated; completers; R0008057:Table 2

Discontinuation due to adverse events (8 lines; O26)

Arm	Statistic	Events / N	Detail
A2	events	4 /	not stated; other; nausea, vomiting, and diarrhea; R0008057:Methods
A2	events	3 /	not stated; other; gastrointestinal side effects; R0006572:Patients and Methods
A3	events	4 /	not stated; other; urinary tract infections; R0006572:Patients and Methods
A3	events	4 /	not stated; other; urinary tract infections; R0008057:Methods
A4	events	2 /	not stated; other; prolonged gastrointestinal symptoms; R0008057:Methods
A4	events	2 /	not stated; other; urinary tract infection; R0008057:Methods
A4	events	3 /	not stated; other; intense gastrointestinal symptoms; R0006572:Patients and Methods
A4	events	1 /	not stated; other; urinary tract infection; R0006572:Patients and Methods

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A2	events	3 /	not stated; other; gastrointestinal side effects; R0006572:Patients and Methods
A2	events	4 /	not stated; other; nausea, vomiting, and diarrhea; R0008057:Methods
A4	events	3 /	not stated; other; intense gastrointestinal symptoms; R0006572:Patients and Methods
A4	events	2 /	not stated; other; prolonged gastrointestinal symptoms; R0008057:Methods