Heart failure with insulin degludec versus glargine U100 in patients with type 2 diabetes at high risk of cardiovascular disease: DEVOTE 14

Table 3 Temporal association between severe hypoglycemia and subsequent risk of experiencing hHF in DEVOTE and LEADER

Time window (days after each severe hypoglycemic event)	DEVOTE (SMQ definition)								LEADER (SMQ definition)								LEADER (EAC confirmed)
	Degludec		Glargine U100		Main analysis		Sensitivity analysis^a		Liraglutide		Placebo		Main analysis		Sensitivity analysis^a		Liraglutide		Placebo		Main analysis		Sensitivity analysis^a
	N	E	N	E	HR^b	p-value	HR^b	p-value	N	E	N	E	HR^b	p-value	HR^b	p-value	N	E	N	E	HR^b	p-value	HR^b	p-value
0–end trial	173	10	238	18	2.2	0.0002	1.7	0.0119	106	8	136	17	3.0	< 0.0001	2.3	< 0.0001	108	5	141	17	3.2	< 0.0001	2.4	0.0001
0–7	173	1	238	2	11.1	< 0.0001	9.8	< 0.0001	106	1	136	3	32.7	< 0.0001	23.1	< 0.0001	108	0	141	2	N/A	–	N/A	–
8–end trial	173	10	238	18	1.6	0.0358	1.3	0.2507	106	8	136	17	2.3	<0.0001	1.7	0.0109	108	5	141	17	3.3	< 0.0001	2.4	< 0.0001

Total number of patients experiencing severe hypoglycaemia: DEVOTE, degludec n = 187, glargine U100 n = 252 [38]; LEADER, liraglutide n = 114, placebo n = 153 [46]
For events occurring on the same day as a hypoglycemic event, 0.5 days were added to the day of the event
CV cardiovascular, E number of events, EAC Event Adjudication Committee; eGFR estimated glomerular filtration rate, glargine U100 insulin glargine 100 units/mL, hHF hospitalization for heart failure, HR hazard ratio, N number of patients, N/A analysis did not converge, SMQ standardized Medical Dictionary for Regulatory Activities Query
^aAdjusted for sex, region, age, eGFR, smoking status, diabetes duration, CV risk, and whether or not the patients were insulin naïve
^bhHF with prior severe hypoglycemia in window versus hHF without severe hypoglycemia in window

ISSN: 1475-2840