TABLE 6: Results at Week 52 in a Trial Comparing TRESIBA to Insulin glargine U-100 (Study A) and Week 26 in a Trial Comparing TRESIBA to Insulin detemir (Study B) in Patients with Type 1 Diabetes Mellitus receiving Insulin aspart at Mealtimes

 Study A
 Study B
 
 TRESIBA + Insulin aspart
 Insulin glargine U-100 + Insulin aspart
 TRESIBA + Insulin aspart
 Insulin detemir + Insulin aspart
 
N
 472
 157
 302
 153
 
HbA1c (%)
  
Baseline
 7.7
 7.7
 8.0
 8.0
 
End of trial
 7.3
 7.3
 7.3
 7.3
 
Adjusted mean change from baseline*
 -0.36
 -0.34
 -0.71
 -0.61
 
Estimated treatment difference [95%CI]

TRESIBA - Insulin glargine U-100
 -0.01 [-0.14;0.11]
 -0.09 [-0.23;0.05]
 
Proportion Achieving HbA1c < 7% at Trial End
 39.8%
 42.7%
 41.1%
 37.3%
 
FPG (mg/dL)
  
Baseline
 165
 174
 178
 171
 
End of trial
 141
 149
 131
 161
 
Adjusted mean change from baseline
 -27.6
 -21.6
 -43.3
 -13.5
 
Daily basal insulin dose
    
Baseline mean
 28 U
 26 U
 22 U
 22 U
 
Mean dose at end of study
 29 U1
 31 U1
 25 U2
 29 U2
 
Daily bolus insulin dose
    
Baseline mean
 29 U
 29 U
 28 U
 31 U
 
Mean dose at end of study
 32 U1
 35 U1
 36 U2
 41 U2
 
 
1At Week 52
 
2At Week 26
 
*The change from baseline to end of treatment visit in HbA 1c was analysed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA 1c as covariates.
 
In Study A, there were 14.8% of subjects in the TRESIBA and 11.5% Insulin glargine arms for whom data was missing at the time of the HbA 1c measurement.
 
In Study B, there were 6.3% of subjects in the TRESIBA and 9.8% Insulin detemir arms for whom data was missing at the time of the HbA 1c measurement.
Study C: TRESIBA Administered at the Same Time each Day or at Any Time each Day in Combination with a Rapid-Acting Insulin Analog at Mealtimes

The efficacy of TRESIBA was eva luated in a 26-week randomized, open-label, multicenter trial in 493 patients with type 1 diabetes mellitus. Patients were randomized to TRESIBA injected once-daily at the same time each day (with the main evening meal), to TRESIBA injected once daily at any time each day or to insulin glargine U-100 injected once-daily according to the approved labeling. The any time each day TRESIBA arm was designed to simulate a worst-case scenario injection schedule of alternating short and long, once daily, dosing intervals (i.e., alternating intervals of 8 to 40 hours between doses). TRESIBA in this arm was dosed in the morning on Monday, Wednesday, and Friday and in the