Table 4.
(a) Estimated rates of confirmed hypoglycemia per treatment arm, based on a negative binomial model | ||||||||
---|---|---|---|---|---|---|---|---|
IDegLira (N = 199) | GLP-1RA add-on to basal insulin (N = 225) | Basal–bolus with insulin glargine as basal component (N = 56) | Basal-only (up-titrated insulin glargine) (N = 329) | |||||
Events/100 PYE | 95% CI | Events/100 PYE | 95% CI | Events/100 PYE | 95% CI | Events/100 PYE | 95% CI | |
Overall confirmed hypoglycemia | 122.8 | (90.71; 166.14) | 124.4 | (89.49; 172.84) | 1060.8** | (680.17; 1654.37) | 286.1** | (231.10; 354.08) |
Severe hypoglycemia | 0.4 | (0.04; 4.68) | NA | NA | 2.4 | (0.38; 14.63) | 2.6 | (0.86; 7.94) |
Non-severe hypoglycemia | 121.9 | (89.90; 165.23) | 124.1 | (89.16; 172.68) | 1056.3** | (675.44; 1651.96) | 282.8** | (228.06; 350.58) |
(b) Estimated rate ratios for confirmed hypoglycemia, based on a negative binomial model | |||||||||
---|---|---|---|---|---|---|---|---|---|
IDegLira versus GLP-1RA add-on to basal insulin | IDegLira versus basal–bolus with insulin glargine as basal component | IDegLira versus basal-only (up-titrated insulin glargine) | |||||||
Rate ratio | 95% CI | P value | Rate ratio | 95% CI | P value | Rate ratio | 95% CI | P value | |
Overall confirmed hypoglycemia | 0.99 | (0.63; 1.54) | 0.95 | 0.12 | (0.07; 0.20) | <0.0001 | 0.43 | (0.30; 0.62) | <0.0001 |
Severe hypoglycemia | NA | NA | NA | 0.18 | (0.01; 2.77) | 0.22 | 0.16 | (0.01; 1.81) | 0.14 |
Non-severe hypoglycemia | 0.98 | (0.63; 1.54) | 0.94 | 0.12 | (0.07; 0.20) | <0.0001 | 0.43 | (0.30; 0.63) | <0.0001 |
IDegLira significantly different: ** P < 0.01
NA Not applicable: could not be estimated as no severe hypoglycemic events were observed with GLP-1RA add-on to basal insulin
Confirmed hypoglycemia was defined as the occurrence of severe episodes (i.e., requiring assistance), or episodes in which plasma glucose concentration (confirmed by self-monitored blood glucose) was less than 56 mg/dL (3.1 mmol/L), irrespective of symptoms
CI confidence interval, GLP-1RA glucagon-like peptide-1 receptor agonist, IDegLira insulin degludec/liraglutide, PYE patient-year of exposure