TABLE 3.

Safety of IDegLira and iGlarLixi in Phase 3 Trials

PopulationPatients With Type 2 Diabetes Uncontrolled on Basal InsulinPatients With Type 2 Diabetes Uncontrolled on a GLP-1 Receptor Agonist
TrialDUAL II (47)DUAL V (48)LixiLan-L(50)DUAL III (49)
TreatmentIDegLiraInsulin degludecIDegLiraInsulin glargine U100iGlarLixiInsulin glargine U100IDegLiraUnchanged GLP-1 Receptor Agonist
n199199278279365365292146
Hypoglycemia (% [events/PYE])
 Overall24.1 (1.5)24.6 (2.6)28.4 (2.23)*49.1 (5.05)40.0 (3.03)42.5 (4.22)32 (2.82)2.8 (0.12)
 Nocturnal6.0 (0.22)8.5 (0.32)6.1 (0.22)*24.4 (1.23)NRNR11 (0.454)0.7 (0.015)
 Severen = 1n = 0n = 0n = 11.1 (0.02)0.3 (<0.01)0.3 (0.007)0 (0)
Body weight (kg)
 Baseline (SD)95.4 (19)93.5 (20)88.3 (17.5)87.3 (15.8)87.7 (14.5)87.1 (14.8)95.6 (16.6)95.5 (17.3)
 End of trial (SD)NRNR86.9 (17.2)89.1 (15.9)87.5 (14.4)88.0 (15.1)NRNR
 Change (SD)–2.7 (NR)*0.0 (NR)–1.4 (3.5)*1.8 (3.6)–0.7 (SE 0.2)*0.7 (SE 0.2)2.0 (3.9)–0.8 (3.0)
Adverse event (% [events/PYE])57.8 (4.0)61.3 (3.6)57.6 (3.43)50.5 (2.86)53.4 (NR)52.3 (NR)65.6 (4.10)63.4 (3.64)
Serious adverse event (% [events/PYE])3.5 (0.12)5.5 (0.14)1.8 (0.04)3.2 (0.07)5.5 (NR)4.9 (NR)3.1 (0.09)2.1 (0.05)
Nausea (% [events/PYE])6.5 (0.22)3.5 (0.08)9.4 (0.26)1.1 (0.02)10.4 (NR)0.5 (NR)3.1 (0.08)4.1 (0.11)
MACE (n)1211similar %similar %20
Pancreatitis (n)00000000
Pancreatic carcinoma (n)01000000
Medullary thyroid carcinoma/thyroid neoplasm (n)0000NRNR00
  • * Significant difference between treatments in favor of IDegLira/iGlarLixi.

  • Significant difference in favor of comparator.

  • Rate of severe hypoglycemia was not reported.

  • NR, not reported;

  • PYE, patient-year of exposure;

  • SE, standard error.