Patients (n [%]) with . | iGlarLixi (n = 365) . | iGlar (n = 365) . |
---|---|---|
At least one TEAE | ||
Any TEAE | 195 (53.4) | 191 (52.3) |
Serious TEAE | 20 (5.5) | 18 (4.9) |
TEAE leading to death | 1 (0.3) | 2 (0.5) |
TEAE leading to discontinuation | 10 (2.7) | 3 (0.8) |
AE by organ class in ≥5% of patients | ||
Infections and infestations | 98 (26.8) | 112 (30.7) |
Nervous system disorders | 39 (10.7) | 19 (5.2) |
Gastrointestinal disorders (overall) | 62 (17.0) | 29 (7.9) |
Nausea | 38 (10.4) | 2 (0.5) |
Discontinuation due to nausea | 4 (1.1) | 0 |
Vomiting | 13 (3.6) | 2 (0.5) |
Discontinuation due to vomiting | 0 | 0 |
Diarrhea | 16 (4.4) | 10 (2.7) |
Discontinuation due to diarrhea | 0 | 0 |
Documented hypoglycemia | ||
Symptomatic* | ||
Patients with events, n (%) | 146 (40.0) | 155 (42.5) |
Events per patient-year†, n | 3.03 | 4.22 |
Severe‡ | ||
Patients with events, n (%) | 4 (1.1) | 1 (0.3) |
Events per patient-year†, n | 0.02 | <0.01 |
Event rate ratio (95% CI) vs. iGlar | 0.77 (0.55–1.07) | – |
Patients (n [%]) with . | iGlarLixi (n = 365) . | iGlar (n = 365) . |
---|---|---|
At least one TEAE | ||
Any TEAE | 195 (53.4) | 191 (52.3) |
Serious TEAE | 20 (5.5) | 18 (4.9) |
TEAE leading to death | 1 (0.3) | 2 (0.5) |
TEAE leading to discontinuation | 10 (2.7) | 3 (0.8) |
AE by organ class in ≥5% of patients | ||
Infections and infestations | 98 (26.8) | 112 (30.7) |
Nervous system disorders | 39 (10.7) | 19 (5.2) |
Gastrointestinal disorders (overall) | 62 (17.0) | 29 (7.9) |
Nausea | 38 (10.4) | 2 (0.5) |
Discontinuation due to nausea | 4 (1.1) | 0 |
Vomiting | 13 (3.6) | 2 (0.5) |
Discontinuation due to vomiting | 0 | 0 |
Diarrhea | 16 (4.4) | 10 (2.7) |
Discontinuation due to diarrhea | 0 | 0 |
Documented hypoglycemia | ||
Symptomatic* | ||
Patients with events, n (%) | 146 (40.0) | 155 (42.5) |
Events per patient-year†, n | 3.03 | 4.22 |
Severe‡ | ||
Patients with events, n (%) | 4 (1.1) | 1 (0.3) |
Events per patient-year†, n | 0.02 | <0.01 |
Event rate ratio (95% CI) vs. iGlar | 0.77 (0.55–1.07) | – |
Patient-years of exposure were calculated as the time from the first to the last injection of the investigational drug plus 1 day. Symptomatic hypoglycemia defined as symptomatic hypoglycemia recorded on the dedicated electronic case report form and meeting the protocol definition for severe or documented hypoglycemia. On-treatment period is defined as the time from the first injection of investigational drug up to 1 day for symptomatic hypoglycemia after the last injection of investigational drug, regardless of the introduction of rescue therapy. TEAE, treatment-emergent AE.
*Defined as plasma glucose ≤70 mg/dL [≤3.9 mmol/L]).
†Calculated as number of events divided by total patient-years of exposure.
‡In these cases, most had confounding circumstances that likely contributed to the development of the event, such as excessive exercise and diminished oral intake before the events.