parallel randomized trial

BEYOND

Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes: a Randomized Controlled Trial

Type 2 diabetes (adults)NCT04196231S002277

Design

Randomized: 305
Start year: 2019
Treatment: 104.28 weeks, follow-up 104.28 weeks
Countries: Italy (1 sites)
Sponsor: University of Campania Luigi Vanvitelli (non industry)
Eligibility: age over 35; HbA1c above 7.5 percent; basal bolus insulin 6 months or more; eGFR 60 or more

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Basal bolus insulin BBI intensification	with or without metformin; lifestyle: not reported	101	101
A2	insulin degludec and liraglutide (IDegLira) or insulin glargine and lixisenatide (iGlarLixi) Basal insulin plus GLP-1RA fixed ratio combination	with or without metformin; lifestyle: not reported	102	102
A3	Basal insulin sglt2i Basal insulin plus gliflozin	with or without metformin; lifestyle: not reported	102	102

Baseline characteristics

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

Characteristic	Statistic	Basal bolus insulin A1	Basal insulin plus GLP-1RA fixed ratio combination A2	Basal insulin sglt2i A3
age	mean (years)	62.1	62.6	60.5
age	sd (years)	10.2	9.6	10.3
bmi	mean (kg/m2)	31.9	32.6	31.6
bmi	sd (kg/m2)	3.7	4.9	4.3
diabetes duration	mean (years)	17.3	17.0	16.9
diabetes duration	sd (years)	8.1	9.6	8.7
egfr	mean (mL/min/1.73 m2)	73.6	76.2	81.7
egfr	sd (mL/min/1.73 m2)	22.8	22.0	18.9
established cvd	n	34	36	32
established cvd	percent	33.6	35.1	31.3
hba1c	mean (percent)	8.5	8.5	8.7
hba1c	sd (percent)	1.1	1.0	1.1
insulin dose	mean (U/day)	49.3	53.4	47.8
insulin dose	sd (U/day)	21.2	27.6	21.4
metformin use	n	56	53	50
metformin use	percent	55.4	51.9	49.0
other male	n	40	42	44
other male	percent	39.6	41.1	43.1
sbp	mean (mmHg)	134.2	133.2	131.3
sbp	sd (mmHg)	21.2	17.5	12.5
weight	mean (kg)	86.9	89.3	86.7
weight	sd (kg)	10.7	12.9	10.4

Analyses this trial contributes to

Results

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

HbA1c change (26 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26.07	A1	change	-0.6 percent	0.8		101	not stated; per protocol; R0022468:Table 2
26.07	A1	change	-0.6 percent	0.8		101	not stated; randomized; R0011577:Table 2
26.07	A2 vs A1	md	-0.09 percent		-0.18 to 0.28		not stated; randomized; R0011577:Results
26.07	A2	change	-0.6 percent	0.8		102	not stated; randomized; R0011577:Table 2
26.07	A2	change	-0.6 percent	0.8		90	not stated; per protocol; R0022468:Table 2
26.07	A3	change	-0.7 percent	0.9		102	not stated; randomized; R0011577:Table 2
26.07	A3 vs A1	md	0.08 percent		-0.10 to 0.25		not stated; randomized; R0011577:Results
26.07	A3	change	-0.7 percent	0.9		93	not stated; per protocol; R0022468:Table 2
52.14	A1	change	-1.1 percent	0.9		101	not stated; randomized; R0022468:Table 2
52.14	A1	change	-1.1 percent	0.9		99	not stated; per protocol; R0022468:Table 2
52.14	A2	change	-0.7 percent	1.1		102	not stated; randomized; R0022468:Table 2
52.14	A2	change	-1.0 percent	1.0		70	not stated; per protocol; R0022468:Table 2
52.14	A3	change	-0.6 percent	0.9		102	not stated; randomized; R0022468:Table 2
52.14	A3	change	-0.8 percent	0.9		75	not stated; per protocol; R0022468:Table 2
104.28	A1	change	-1.3 percent	1.0		101	not stated; randomized; R0022468:Table 2
104.28	A1	change	-1.3 percent	1.0		98	not stated; per protocol; R0022468:Table 2
104.28	A1	final	7.2 percent	0.8		101	not stated; randomized; R0022468:Table 2
104.28	A1	final	7.2 percent	0.8		98	not stated; per protocol; R0022468:Table 2
104.28	A2	final	7.3 percent	0.9		58	not stated; per protocol; R0022468:Table 2
104.28	A2	final	7.7 percent	0.9		102	not stated; randomized; R0022468:Table 2
104.28	A2	change	-1.2 percent	1.0		58	not stated; per protocol; R0022468:Table 2
104.28	A2	change	-0.8 percent	1.1		102	not stated; randomized; R0022468:Table 2
104.28	A3	final	7.5 percent	1.0		54	not stated; per protocol; R0022468:Table 2
104.28	A3	final	7.9 percent	1.0		102	not stated; randomized; R0022468:Table 2
104.28	A3	change	-1.2 percent	1.1		54	not stated; per protocol; R0022468:Table 2
104.28	A3	change	-0.8 percent	1.1		102	not stated; randomized; R0022468:Table 2

Body weight change in kilograms (diabetes) (6 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26.07	A1	change	0.3 kg	1.5	101	not stated; randomized; R0011577:Table 2
26.07	A2	change	-1.9 kg	4.3	102	not stated; randomized; R0011577:Table 2
26.07	A3	change	-0.6 kg	1.9	102	not stated; randomized; R0011577:Table 2
104.28	A1	change	1.8 kg	1.5	98	not stated; per protocol; R0022468:Table 4
104.28	A2	change	-2.2 kg	2.3	58	not stated; per protocol; R0022468:Table 4
104.28	A3	change	-0.9 kg	1.2	54	not stated; per protocol; R0022468:Table 4

HbA1c below 7 percent (9 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26.07	A1	responders	19	101	not stated; randomized; R0011577:Figure 1
26.07	A2	responders	19	102	not stated; randomized; R0011577:Figure 1
26.07	A3	responders	16	102	not stated; randomized; R0011577:Figure 1
52.14	A1	responders	45	99	not stated; per protocol; R0022468:Table 3
52.14	A2	responders	45	70	not stated; per protocol; R0022468:Table 3
52.14	A3	responders	41	75	not stated; per protocol; R0022468:Table 3
104.28	A1	responders	50	98	not stated; per protocol; R0022468:Results
104.28	A2	responders	47	58	not stated; per protocol; R0022468:Results
104.28	A3	responders	45	54	not stated; per protocol; R0022468:Results

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	17.8	101	not stated; other; R0011577:Results
A1	events	24.8	101	not stated; other; R0022468:Results
A2	events	7.8	102	not stated; other; R0011577:Results
A2	events	12.8	102	not stated; other; R0022468:Results
A3	events	5.9	102	not stated; other; R0011577:Results
A3	events	9.9	102	not stated; other; R0022468:Results

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26.07	A1	change	1.9 mmHg	12.4	101	not stated; randomized; R0011577:Table 2
26.07	A2	change	0.85 mmHg	15.7	102	not stated; randomized; R0011577:Table 2
26.07	A3	change	-3.4 mmHg	17.2	102	not stated; randomized; R0011577:Table 2

Health related quality of life total score (any instrument) (6 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26.07	A1	final	15.7 points	5.9		not stated; randomized; R0011577:Results
26.07	A2	final	34.2 points	3.7		not stated; randomized; R0011577:Results
26.07	A3	final	33.8 points	4.1		not stated; randomized; R0011577:Results
104.28	A1	change	1.6 points	3.1	98	not stated; per protocol; R0022468:Table 4
104.28	A2	change	17.4 points	11.6	58	not stated; per protocol; R0022468:Table 4
104.28	A3	change	16.9 points	9.1	54	not stated; per protocol; R0022468:Table 4

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	not stated; other; R0011577:Results
A2	events	4 / 102	not stated; other; R0011577:Results
A2	events	5 / 102	not stated; other; R0022468:Results
A3	events	7 / 102	not stated; other; R0022468:Results
A3	events	3 / 102	not stated; other; R0011577:Results

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 101	not stated; other; R0011577:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0022468:Results
	A2	events				0 /	not stated; other; R0011577:Results