g; arm were missing the final
HbA1c assessment.
Study C (NCT01850615): FIASP® added to basal insulin andmetformin in patients with Type 2 DM inadequately controlled atbaseline on basal insulin and metformin
The efficacy of FIASP® was eva luated in an 18-week randomized,open-label, parallel group trial in 236 adult patients with type 2diabetes who were inadequately controlled on basal insulin andmetformin therapy, either with or without other oral antidiabetictherapy, for at least 3 months. Patients were randomized to either
mealtime FIASP® in addition to basal insulin and metformin or tocontinuing basal insulin and metformin therapy without FIASP®.
The basal insulins used in both treatment arms were insulinglargine, insulin detemir or NPH. All patients were also required tobe on ≥1000 mg metformin treatment at baseline.
The mean age of the trial population was 57.4 years and the meanduration of diabetes was 11.3 years. 48% were male, 70% wereWhite, 4% were Black or African American, and 37% were Hispanic.The mean BMI was 30.8 kg/m2.
After 18 weeks of treatment, addition of FIASP® to basal insulinand metformin statistically significantly reduced HbA1c comparedto continuing basal insulin and metformin therapy without additionof FIASP® (Table 8).
Table 8. Results from Study C: 18-Week Trial of MealtimeFIASP® in Adults with Type 2 Diabetes InadequatelyControlled at Baseline on Basal Insulin and Metformin
FIASP® + basal
insulin + metformin
Basal insulin
+ metformin
Number of subjects randomized (N) 116 120
HbA1c (%)
Baseline 7.9 7.9
Adjusted change from baseline -1.16 -0.22
Estimated treatment difference vs.
basal insulin+metformin [95%CI] -0.94 [-1.17; -0.72]*
Proportion of patients Achieving
HbA1c < 7% at Trial End 60.3% 18.3%
Baseline is based on the mean of the observed last available values
prior to randomization.
*p<0.0001, 1-sided p-value eva luated at 2.5% level for superiority.
6.0% of subjects on the mealtime FIASP® arm and 3.3% of
subjects on the placebo arm were missing the final HbA1c
assessment.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
FIASP® (insulin aspart injection) 100 units of insulin aspart per mL(U-100) is available as a clear and colorless solution in the followingpresentations and packaging configurations:
Carton of one 10 mL multiple-dose vials NDC 0169-3201-11
Carton of five 3 mL single-patient use NDC 0169-3204-15
FIASP® FlexTouch® pen
Carton of five 3 mL single-patient-use NDC 0169-3205-15
PenFill® cartridges*
The FIASP® FlexTouch® pen dials in 1 unit increments.
*FIASP® PenFill® cartridges are designed for use withNovo Nordisk insulin delivery devices.
16.2 Recommended Storage
Unused FIASP® vials should be stored between 2° to 8°C (36° to46°F) in a refrigerator, but not in or near a freezing compartment.
FIASP® should not be exposed to excessive heat or light and mustnever be frozen. Do not freeze FIASP® and do not use FIASP®
if it has been frozen. FIASP® should not be drawn into a syringeand stored for later use. Only use the product if it has a clear andalmost colorless appearance.
Keep the cap on the pen in order to protect from light. Keep unusedvials and FIASP® FlexTouch® in the carton so they will stay cleanand protected from light.
Always remove the needle after each injection and st |
