Table 1.
Participating countries*.
Table 2.
Titration algorithm for IDegAsp or IGlar.
Fig 1.
Study flow diagram; core and extension study phases.
IDegIAsp, insulin degludec/insulin aspart; IGlar, insulin glargine (U100); OD, once daily; n, number of participants.
Table 3.
Participant demographics and baseline characteristics.
Fig 2.
(A) Mean HbA1c over time to 52 weeks, (B) mean fasting plasma glucose (FPG) over time to 52 weeks, (C) mean self-measured blood glucose profile at baseline, Week 0 and Week 52, and (D) mean prandial increment at breakfast, lunch, main evening meal and overall at 52 weeks. (A) and (B): Data are mean ± SEM in the full analysis set. Missing data were imputed using last observation carried forward. *Calculated, not measured. Treatment differences are derived from a least square means-based model. (C) and (D): Full analysis set. Missing data were imputed using last observation carried forward. Prandial increment is the difference between SMPG values after meal (90 min) and before meal. Comparisons: estimates adjusted for multiple covariates. *Indicate statistically significant difference at Week 52 before breakfast (p < 0.05), and at 04.00 h and at breakfast the following day (p < 0.0001). **Before breakfast: estimated treatment difference (ETD) 0.81 mmol/L; 95% CI 0.46, 1.17. †At 4.00 h: ETD 0.53 mmol/L; 95% CI 0.10, 0.95. ‡Before breakfast the following morning: ETD 0.89 mmol/L; 95% CI 0.56, 1.23. IDegIAsp, insulin degludec/insulin aspart; HbA1c, glycosylated hemoglobin; IGlar, insulin glargine (U100); OD, once daily; SEM, standard error of the mean; SMPG, self-measured plasma glucose.
Fig 3.
(A) Confirmed and (B) nocturnal confirmed hypoglycemic events over 52 weeks. Safety analysis set. Comparisons: estimates adjusted for multiple covariates. IDegIAsp, insulin degludec/insulin aspart; IGlar, insulin glargine (U100); OD, once daily.
Fig 4.
Cumulative frequency of hypoglycemia.
* (A) Core phase and (B) extension phase. *Safety analysis set.IDegIAsp, insulin degludec/insulin aspart; IGlar, insulin glargine (U100); OD, once daily.