Table 1

Key analyses and results (full analysis set)

TI-Gen2 (n = 174)Insulin aspart (n = 170)Treatment difference
HbA1c (% [mmol/mol])*
 Baseline7.94 (63.3)7.92 (63.1)
 Week 247.73 (61.0)7.52 (58.7)0.19 (2.1)
 Adjusted mean change−0.21 (–2.3)−0.40 (–4.4)
 95% CI–0.33 to –0.09–0.52 to –0.280.02 to 0.36
HbA1c ≤7.0% (53.0 mmol/mol)
 Incidence (%)24 (18.3)46 (30.7)OR = 0.449
 95% CI0.23 to 0.86
P = 0.0158
HbA1c ≤6.5% (47.5 mmol/mol)
 Incidence (%)10 (7.6)19 (12.7)OR = 0.576
 95% CI0.24 to 1.38
P = 0.2144
FPG (mg/dL)*
 Baseline (SE)153.9 (5.3)151.6 (5.4)
 Adjusted mean change (SE)−25.3 (7.6)10.2 (7.4)−35.4 (10.6)
 95% CI−56.3 to –14.6
P = 0.001
Body weight, kg
 Baseline (SE)75.5 (16.1)73.5 (15.3)
 Adjusted mean change (SE)−0.4 (0.4)0.9 (0.4)−1.3 (0.5)
 95% CI−2.33 to –0.31
P = 0.0102
All hypoglycemia§
 Incidence (%)167 (96.0)170 (99.4)P = 0.0621
 Event rate (events/patient-month)9.814.0P < 0.0001
Severe hypoglycemia§
 Incidence (%)32 (18.4)50 (29.2)P = 0.0156
 Event rate (events/100 patient-months)8.114.5P = 0.1022
  • OR, odds ratio.

  • *Assessed using MMRM analysis.

  • †Assessed using logistic regression analysis.

  • ‡Assessed using ANCOVA.

  • §Incidence was based on the safety population, which was 174 for the TI-Gen2 group and 171 for the insulin aspart group. Incidence was assessed using logistic regression analysis. Event rate was assessed using negative binomial analysis.