parallel randomized trial

ENDIS

Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients

Type 1 diabetes NCT05857085S000977

Design

Randomized: 91
Start year: 2021
Treatment: 12 weeks, follow-up 12 weeks
Countries: Slovenia (1 sites)
Sponsor: General and Teaching Hospital Celje (non industry)
Eligibility: type 1 diabetes on MDI or CSII with CGM; HbA1c 9.0 or less; BMI 22 or more; CrCl 60 or more; no atherosclerotic disease

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Analyzed
A1	Empagliflozin Empagliflozin add on to insulin	insulin by MDI or CSII with CGM; lifestyle: not reported	30
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide add on to insulin	insulin by MDI or CSII with CGM; lifestyle: not reported	30
A3	Standard care or no added treatment Control, insulin only	insulin by MDI or CSII with CGM; lifestyle: not reported	29

Baseline characteristics

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

Characteristic	Statistic	Empagliflozin A1	Semaglutide 1.0 mg subcutaneous once weekly A2	Standard care or no added treatment A3
age	mean (years)	48.2	48.5	47.0
age	sd (years)	10.7	9.6	12
bmi	mean (kg/m2)	27.7	28.2	26.9
bmi	sd (kg/m2)	4.3	4.8	3.0
diabetes duration	mean (years)	21.3	21.9	18.8
diabetes duration	sd (years)	10.2	11.2	11.9
egfr	mean (mL/min/1.73 m2)	86.1	85.8	86.5
egfr	sd (mL/min/1.73 m2)	9.2	8.3	7.8
hba1c	mean (percent)	7.88	7.42	7.04
hba1c	sd (percent)	0.72	0.80	0.90
other male	n	18	19	17
other male	percent	60	63.3	58.6
sbp	mean (mmHg)	132.5	134.7	130.5
sbp	sd (mmHg)	15.7	16.4	13.6
waist	mean (cm)	99.9	99.5	98.5
waist	sd (cm)	11.7	14.3	9.9
weight	mean (kg)	81.9	84.6	82.6
weight	sd (kg)	14.2	16.4	11.7

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-0.24 percent	0.59	30	not stated; completers; R0021681:Table 2
12	A2	change	-0.29 percent	0.61	30	not stated; completers; R0021681:Table 2
12	A3	change	0.12 percent	0.44	29	not stated; completers; R0021681:Table 2

Total daily insulin dose change (3 lines; O06)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-5.1 IU/day	10.0	30	not stated; completers; R0021681:Table 2
12	A2	change	-8.5 IU/day	9.3	30	not stated; completers; R0021681:Table 2
12	A3	change	-1.1 IU/day	7.5	29	not stated; completers; R0021681:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 30	not stated; randomized; R0021681:Results
A2	events	1 /	not stated; randomized; R0021681:Results
A3	events	0 /	not stated; randomized; R0021681:Results

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 30	not stated; randomized; R0021681:Results
A2	events	1 /	not stated; randomized; R0021681:Results
A3	events	0 /	not stated; randomized; R0021681:Results