parallel randomized trial

NCT04451837

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

Type 2 diabetes (adults)NCT04451837S001033

Design

Randomized: 239
Start year: 2020
Treatment: 26.07 weeks, follow-up 26.07 weeks
Countries: Sweden (1 sites)
Sponsor: Region Skane (non industry)
Eligibility: age 18 or older; SIDD or SIRD cluster; stable metformin monotherapy; HbA1c 42 to 90 mmol/mol

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	metformin; lifestyle: not reported		107
A2	Dapagliflozin Dapagliflozin 10 mg	metformin; lifestyle: not reported		113

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Dapagliflozin A2	Whole trial ALL
age cluster:sidd	mean (years)	63	63
age cluster:sidd	sd (years)	10	10
age cluster:sird	mean (years)	69	68
age cluster:sird	sd (years)	9	7
age	mean (years)			66
age	sd (years)			10
bmi cluster:sidd	mean (kg/m2)	28.3	29.1
bmi cluster:sidd	sd (kg/m2)	4.1	5.1
bmi cluster:sird	mean (kg/m2)	34.3	33.8
bmi cluster:sird	sd (kg/m2)	4.4	5.9
bmi	mean (kg/m2)			31.2
bmi	sd (kg/m2)			5.6
diabetes duration cluster:sidd	mean (years)	5.2	4.7
diabetes duration cluster:sidd	sd (years)	3.1	4.3
diabetes duration cluster:sird	mean (years)	4.4	3.8
diabetes duration cluster:sird	sd (years)	3.3	3.0
diabetes duration	mean (years)			4.6
diabetes duration	sd (years)			3.5
egfr cluster:sidd	mean (mL/min/1.73 m2)	75.2	78.3
egfr cluster:sidd	sd (mL/min/1.73 m2)	13.4	11.3
egfr cluster:sird	mean (mL/min/1.73 m2)	66.8	68.8
egfr cluster:sird	sd (mL/min/1.73 m2)	11.2	11.4
egfr	mean (mL/min/1.73 m2)			72.5
egfr	sd (mL/min/1.73 m2)			12.7
hba1c cluster:sidd	mean (mmol/mol)	57.4	57.5
hba1c cluster:sidd	sd (mmol/mol)	9.9	11.0
hba1c cluster:sird	mean (mmol/mol)	54	53
hba1c cluster:sird	sd (mmol/mol)	7.7	7.6
hba1c	mean (mmol/mol)			55.5
hba1c	sd (mmol/mol)			9.4
other male cluster:sidd	n	45	46
other male cluster:sidd	percent	71.4	73.0
other male cluster:sird	n	34	40
other male cluster:sird	percent	59.7	71.4
other male	n			165
other male	percent			69.0
sbp cluster:sidd	mean (mmHg)	127	130
sbp cluster:sidd	sd (mmHg)	13	13
sbp cluster:sird	mean (mmHg)	132	129
sbp cluster:sird	sd (mmHg)	13	12
sbp	mean (mmHg)			130
sbp	sd (mmHg)			13
uacr cluster:sidd	mean (g/mol)	1.8	1
uacr cluster:sidd	sd (g/mol)	4.7	1.6
uacr cluster:sird	mean (g/mol)	1.6	1.7
uacr cluster:sird	sd (g/mol)	2.8	2.8
uacr	mean (g/mol)			1.5
uacr	sd (g/mol)			3.2
waist cluster:sidd	mean (cm)	104	105
waist cluster:sidd	sd (cm)	11	13
waist cluster:sird	mean (cm)	119	117
waist cluster:sird	sd (cm)	12	15
waist	mean (cm)			111
waist	sd (cm)			14

Analyses this trial contributes to

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26.07	A1 vs A2	md	-8.2 mmol/mol	-10.0 to -6.3		not stated; modified itt; R0007799:Results
26.07	A1	change	-13.4 mmol/mol		56	not stated; modified itt; cluster:sidd; R0007799:Table 2
26.07	A1 vs A2	md	-8.6 mmol/mol	-11.3 to -6.0		not stated; modified itt; cluster:sidd; R0007799:Table 2
26.07	A1 vs A2	md	-9.2 mmol/mol	-12.2 to -6.3		not stated; per protocol; cluster:sidd; R0007799:Table 2
26.07	A1	change	-10.5 mmol/mol		51	not stated; modified itt; cluster:sird; R0007799:Table 2
26.07	A1 vs A2	md	-7.8 mmol/mol	-10.3 to -5.3		not stated; modified itt; cluster:sird; R0007799:Table 2
26.07	A1 vs A2	md	-8.4 mmol/mol	-11.1 to -5.6		not stated; per protocol; cluster:sird; R0007799:Table 2
26.07	A2	change	-2.7 mmol/mol		51	not stated; modified itt; cluster:sird; R0007799:Table 2
26.07	A2	change	-4.7 mmol/mol		62	not stated; modified itt; cluster:sidd; R0007799:Table 2

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26.07	A1	change	-6 mmHg		51	not stated; modified itt; cluster:sird; R0007799:Table 2
26.07	A1 vs A2	md	-5 mmHg	-10 to 0		not stated; modified itt; cluster:sird; R0007799:Table 2
26.07	A1	change	-3 mmHg		56	not stated; modified itt; cluster:sidd; R0007799:Table 2
26.07	A1 vs A2	md	0 mmHg	-4 to 3		not stated; modified itt; cluster:sidd; R0007799:Table 2
26.07	A2	change	-3 mmHg		62	not stated; modified itt; cluster:sidd; R0007799:Table 2
26.07	A2	change	0 mmHg		51	not stated; modified itt; cluster:sird; R0007799:Table 2