Table 2

On-treatment hypoglycemic episodes and AEs, including AEs of special interest (SAS; N = 154)

Icodec LD (n = 54, 21.8 PYE)Icodec NLD (n = 50, 20.3 PYE)IGlar U100 (n = 50, 20.2 PYE)RR (95% CI)* icodec LD/IGlar U100RR (95% CI)* icodec NLD/IGlar U100
n (%)EventsRate*n (%)EventsRaten (%)EventsRate
Hypoglycemic episodes
 Hypoglycemia “alert” value (level 1)19 (35.2)833.80926 (52.0)874.2922 (44.0)763.770.94 (0.44–1.98)1.10 (0.51–2.35)
 Clinically significant (level 2) or severe (level 3) hypoglycemia4 (7.4)170.782 (4.0)30.156 (12.0)160.790.87 (0.18–4.24)0.39 (0.05–2.80)
 Severe hypoglycemia (level 3)§000
AEs
 All AEs28 (51.9)853.9030 (60.0)773.8023 (46.0)763.77
  Serious AEs2 (3.7)7‖32.101 (2.0)10.05
  Fatal AEs000
  Severe AEs1 (1.9)14.61 (2.0)10.050
  AEs leading to withdrawal1 (1.9)14.600
  AEs probably related to basal insulin1 (1.9)29.22 (4.0)50.2473 (6.0)30.15
  AEs possibly related to basal insulin01 (2.0)10.052 (4.0)20.10
 AEs of special interest
  Injection-site reaction#1 (1.9)29.21 (2.0)40.202 (4.0)30.15
  Hypersensitivity event#2 (4.0)29.9
  MACE#1 (1.9)1‖**4.601 (2.0)1**0.05
  • The on-treatment period represents the time period during which participants are considered to be exposed to the trial product. MACE, major adverse cardiovascular event; PYE, patient-years of exposure; RR, rate ratio; SAS, safety analysis set.

  • * The number of hypoglycemic events was analyzed post hoc using a negative binomial regression model with log link. The model included treatment, pretrial insulin treatment, and SGLT2i use as fixed factors and the logarithm of the time period for which the hypoglycemic episodes were considered as an offset.

  • * Rate: number of events per patient-year of exposure.

  • Hypoglycemia “alert” value (level 1): blood glucose value <3.9 mmol/L (<70 mg/dL) and ≥3.0 mmol/L (≥54 mg/dL) confirmed by blood glucose meter.

  • Clinically significant hypoglycemia (level 2): blood glucose value <3.0 mmol/L (<54 mg/dL).

  • § Severe hypoglycemia (level 3): hypoglycemia with severe cognitive impairment requiring external assistance for recovery. ‖Acute myocardial infarction (confirmed by adjudication), fall, joint injury, and upper limb and two facial bone fractures in one patient; muscle abscess in one patient.

  • Myocardial infarction (confirmed by adjudication).

  • # Independently adjudicated and confirmed.

  • ** Also included as serious AEs.