parallel randomized trial

NCT05767255

Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue

Type 2 diabetes (adults)NCT05767255S002117

Design

Randomized: 65
Start year: 2022
Treatment: 4 weeks, follow-up 4 weeks
Countries: Colombia (1 sites)
Sponsor: Hospital Universitario San Ignacio (non industry)
Eligibility: adults hospitalized with T2D needing MDI; HbA1c 8.0 to 15 percent; eGFR 15 or more

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: first 14 days of CGM used for losses

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	other glucose lowering drugs not started during 4 weeks; lifestyle: not reported	32	32	31
A2	Basal bolus insulin Multiple daily insulin injections (glargine and aspart)	other glucose lowering drugs not started during 4 weeks; lifestyle: not reported	33	32	30

Baseline characteristics

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

Characteristic	Statistic	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated A1	Basal bolus insulin A2	Whole trial ALL
age	mean (years)	57	59
age	sd (years)	12.4	10.5
bmi: 25 to 30	n	17	12
bmi: 25 to 30	percent	53.1	37.5
bmi: less than 25	n	7	12
bmi: less than 25	percent	21.9	37.5
bmi: more than 30	n	8	8
bmi: more than 30	percent	25.0	25.0
diabetes duration	median (years)	5.0	7.1
diabetes duration	q1 (years)	0	0
diabetes duration	q3 (years)	10.5	12.5
egfr: 60 to 90	n	7	7
egfr: 60 to 90	percent	21.9	21.9
egfr: less than 60	n	3	3
egfr: less than 60	percent	9.4	9.4
egfr: more than 90	n	22	22
egfr: more than 90	percent	68.8	68.8
established cvd: coronary heart disease	n	0	4
established cvd: coronary heart disease	percent	0	12.5
established cvd: heart failure	n	1	4
established cvd: heart failure	percent	3.1	12.5
established cvd: peripheral artery disease	n	1	2
established cvd: peripheral artery disease	percent	3.1	6.3
established cvd: stroke	n	1	0
established cvd: stroke	percent	3.1	0
hba1c	mean (percent)	11.6	11.6
hba1c	sd (percent)	1.7	1.7
hispanic	percent			100
insulin dose	mean (U/day)	27.1	27.3
insulin dose	sd (U/day)	7.8	7.9
other male	n	17	14
other male	percent	53.1	43.8

Analyses this trial contributes to

Results

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

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
4	A1	change	-2.1 kg	3.5		32	not stated; modified itt; R0007026:Table 2
4	A2	change	1.0 kg	3.4		32	not stated; modified itt; R0007026:Table 2

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	6.2	32	not stated; modified itt; R0007026:Results
A1	events		0 / 32	not stated; modified itt; R0007026:Table 4
A2	events	31.3	32	not stated; modified itt; R0007026:Results
A2	events		10 / 32	not stated; modified itt; R0007026:Table 4

Level 2 or 3 hypoglycemia (episode rate) (5 lines; O04B)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	rate	0.005		32	not stated; modified itt; R0007026:Results
A1	rate			32	not stated; modified itt; R0007026:Table 4
A2 vs A1	rate ratio	15.2	6.2 to 48.2		not stated; modified itt; R0007026:Results
A2	rate	0.086		32	not stated; modified itt; R0007026:Results
A2	rate			32	not stated; modified itt; R0007026:Table 4

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 32	not stated; modified itt; R0007026:Table 4
	A2	events				0 / 32	not stated; modified itt; R0007026:Table 4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0007026:Discussion
	A2	events				0 /	not stated; other; R0007026:Discussion

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0007026:Discussion
	A2	events				0 /	not stated; other; R0007026:Discussion