ment, treatment difference in HbA1c reductionfrom baseline between mealtime FIASP® compared to mealtimeNovoLog®, and the treatment difference between postmeal FIASP®compared to mealtime NovoLog® met the pre-specified non-inferioritymargin (0.4%). See Table 6. Insulin doses were similar amongstudy arms at baseline and at the end of the trial.
Table 6. Results from Study A: 26-Week Trial of MealtimeFIASP® and Postmeal FIASP® compared to Mealtime
NovoLog® Used in Combination with Insulin Detemir in
Adults with Type 1 Diabetes
Mealtime
FIASP®
+ insulin
detemir
Postmeal
FIASP®
+ insulin
detemir
Mealtime
NovoLog®
+ insulin
detemir
Number of subjects randomized (N) 381 382 380
HbA1c (%)
Baseline (mean) 7.6 7.6 7.6
Adjusted mean change from
baseline -0.32 -0.13 -0.17
Estimated treatment difference vs.
mealtime NovoLog® [95% CI]*
-0.15
[-0.23;-0.07]
Estimated treatment difference vs.
mealtime NovoLog® [95% CI]*
0.04
[-0.04;0.12]
Baseline is based on the mean of the observed last available values
prior to randomization.
*Tested for non-inferiority
7.6% of subjects on the Mealtime FIASP® arm, 7.6% of subjects onthe Postmeal FIASP® arm, and 5.3% of subjects on the MealtimeNovoLog® arm were missing the final HbA1c assessment.
14.3 Type 2 Diabetes - Adults
Study B (NCT01819129): FIASP® added to basal insulin and oralantidiabetics in patients with Type 2 DM inadequately controlled atbaseline on basal insulin and oral antidiabeticsThe efficacy of FIASP® was eva luated in a 26-week randomized,double-blind, active controlled, treat-to-target, multicenter, multinational,parallel group trial in 689 adult patients with type 2 diabeteswho were inadequately controlled at baseline on basal insulin andoral antidiabetic therapy and had been on these therapies for at least
6 months. Patients were randomized to either mealtime FIASP® or tomealtime NovoLog®, both in combination with insulin glargine andmetformin in a basal-bolus regimen. Mealtime FIASP® or mealtimeNovoLog® was injected 0-2 minutes before the meal.
The mean age of the randomized subjects was 59.5 years and themean duration of diabetes was 12.7 years. 49% were male, 81%were White, 6% were Black or African American, and 6% wereHispanic. The mean BMI was 31.2 kg/m2.
After 26 weeks of treatment, the treatment difference in HbA1creduction from baseline between mealtime FIASP® and mealtime NovoLog®, both in combination with insulin glargine and metformin,met the pre-specified non-inferiority margin (0.4%). See Table 7.
Insulin doses were similar among study arms at the end of the trial.
Table 7. Results from Study B: 26-Week Trial of Mealtime
FIASP® Compared to Mealtime NovoLog®, Both used
in Combination with Insulin Glargine and Metformin, in
Adults with Type 2 Diabetes
Mealtime
FIASP®
+insulin glargine
+metformin
Mealtime
NovoLog®
+insulin glargine
+metformin
Number of subjects randomized (N) 345 344
HbA1c (%)
Baseline 8.0 7.9
Adjusted change from baseline -1.38 -1.36
Estimated treatment difference
vs. NovoLog® [95%CI]* -0.02 [-0.15;0.10]
Baseline is based on the mean of the observed last available values
prior to randomization.
*Tested for non-inferiority11.9% of subjects on the Mealtime FIASP® arm and 10.2% ofsubjects on the Mealtime NovoLog&re |
