parallel randomized trial

S002986

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

Type 2 diabetes (adults)S002986

Design

Randomized: 120
Start year: 2019
Treatment: 32 weeks, follow-up 32 weeks
Countries: Denmark (1 sites)
Sponsor: (non industry)
Eligibility: T2D HbA1c >=48 mmol/mol; age >=50 with CVD, HF or CKD, or age >=60 with CV risk; eGFR >=45

Conduct and analysis

Blinding: single blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: linear mixed model

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: not reported	30	20
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide	lifestyle: not reported	30	20
A3	Empagliflozin Empagliflozin	lifestyle: not reported	30	20
A4	semaglutide and empagliflozin Combination	lifestyle: not reported	30	20

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Semaglutide 1.0 mg subcutaneous once weekly A2	Empagliflozin A3	Combination A4	Whole trial ALL
age	mean (years)	64.6	70.1	69.6	67.9
age	sd (years)	6.1	6.8	6.0	6.2
bmi	mean (kg/m2)	33	32	33	31
bmi	sd (kg/m2)	6	5	6	5
diabetes duration	median (years)	8.0	8.5	10.0	6.0
diabetes duration	q1 (years)	4.0	3.5	5.0	2.3
diabetes duration	q3 (years)	10.0	16.0	18.5	12.0
egfr	mean (mL/min/1.73 m2)	91	87	88	81
egfr	sd (mL/min/1.73 m2)	23	21	18	26
established cvd	n	9	12	12	13
established cvd	percent	45	60	60	65
hba1c	median (percent)	7.6	7.5	7.4	7.5
hba1c	q1 (percent)	6.8	6.9	6.9	6.7
hba1c	q3 (percent)	8.3	7.8	7.6	8.9
insulin use	n	4	4	6	2
insulin use	percent	20	20	30	10
metformin use	n	18	17	18	20
metformin use	percent	90	85	90	100
other ethnicity inuit	n					1
other male	n	14	17	13	17
other male	percent	70	85	65	85
other sulfonylurea use	n	2	3	2	1
other sulfonylurea use	percent	10	15	10	5
sbp	mean (mmHg)	139	131	139	136
sbp	sd (mmHg)	13	17	15	14
uacr	median (mg/mmol)	1.58	2.83	1.24	1.81
uacr	q1 (mg/mmol)	0.57	0.9	0.9	0.79
uacr	q3 (mg/mmol)	10.74	9.49	2.03	7.23