Fiasp (Page 7 of 13)
14.5 Type 1 Diabetes Mellitus– Adult Continuous Subcutaneous Insulin Infusion (CSII)
Study D (NCT02825251): FIASP in Continuous Subcutaneous Insulin Infusion (CSII) in Adults with Type 1 Diabetes Mellitus
The efficacy and safety of FIASP vs. NovoLog in CSII in adult subjects with type 1 diabetes mellitus (N=472) was evaluated in a randomized, multicenter, multinational, active controlled, treat-to-target, parallel group trial with a 4-week run-in and a 16-week treatment period. Meal-time bolus insulin infusion was initiated 0-2 minutes before a meal.
The mean age of the randomized subjects was 43 years and the mean duration of diabetes was 24 years. 43% were male. 89% were White, 1% were Black or African American, and 1% were Asian; and 3% were Hispanic or Latino. The mean BMI was 26.3 kg/m2.
After 16 weeks of treatment, the treatment difference in HbA1c reduction from baseline between FIASP and NovoLog was 0.10 with 95%CI [0.02, 0.18] (Table 11).
Table 11. Results from Study D: 16-Week Trial FIASP in Adults with Type 1 Diabetes
| FIASP | NovoLog | |
| Number of subjects randomized (N) | 236 | 236 |
| HbA1c (%) | ||
| 7.5 | 7.5 |
| -0.04 | -0.14 |
| 0.10 [0.02; 0.18] | |
| Proportion of patients Achieving HbA1c < 7% at Trial End | 20.3% | 23.3% |
Baseline is based on the mean of the observed last available values prior to randomization.
* Tested for non-inferiority using a margin of 0.4%.
Estimated treatment difference was calculated using ANCOVA.
2.1% of subjects on the FIASP arm and 2.5% of subjects on the NovoLog arm were missing the final HbA1c assessment. Missing values were imputed using multiple imputation with a mean equal to the baseline value of the corresponding patient.
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 following presentations and packaging configurations:
- Carton of one 10 mL multiple-dose vials NDC 0169-3201-11
- Carton of five 3 mL single-patient-use FIASP FlexTouch pens NDC 0169-3204-15
- Carton of five 3 mL single-patient-use PenFill cartridges* NDC 0169-3205-15
- Carton of five 1.6 mL single-patient-use PumpCart cartridges** NDC 0169-3206-15
- The FIASP FlexTouch pen dials in 1 unit increments.
- * FIASP PenFill cartridges are designed for use with Novo Nordisk insulin delivery devices.
- ** FIASP PumpCart cartridges are designed for use in compatible pumps only.
16.2 Recommended Storage
Dispense in the original sealed carton with the enclosed Instructions for Use.
Unused FIASP vials should be stored between 2° to 8°C (36° to 46°F) in a refrigerator, but not in or near a freezing compartment. FIASP should not be exposed to excessive heat or light and must never be frozen. Do not use FIASP if it has been frozen. FIASP should not be drawn into a syringe and stored for later use.
Keep the cap on the pen in order to protect from light. Remove the needle from the FIASP FlexTouch pen after each injection and store without a needle attached. Use a new needle for each injection. Keep unused vials, FIASP FlexTouch, PenFill Cartridges and PumpCart cartridges in the carton so they will stay clean and protected from light.
The storage conditions for vials, FIASP FlexTouch pens, 3 mL PenFill cartridges and 1.6 mL PumpCart cartridges are summarized in Table 12:
Table 12. Storage Conditions for Vial, FIASP FlexTouch, PenFill Cartridges
and PumpCart Cartridges
| FIASP presentation | Not in-use (unopened) | In-use (opened) | ||
| Room Temperature (up to 30°C [86°F]) | Refrigerated (2°C to 8°C [36°F to 46°F]) | Room Temperature (up to 30°C [86°F]) | Refrigerated (2°C to 8°C [36°F to 46°F]) | |
| 10 mL multiple-dose vial | 28 days | Until expiration date | 28 days* (up to 30°C [86°F]) | 28 days* |
| 3 mL single-patient-use FIASP FlexTouch pen | 28 days | Until expiration date | 28 days (up to 30°C [86°F]) | 28 days |
| 3 mL single-patient-use PenFill cartridges | 28 days | Until expiration date | 28 days (up to 30°C [86°F]) | Do not refrigerate |
| 1.6 mL single-patient-use PumpCart cartridges | 18 days** | Until expiration date | 4 days** (up to 37°C [98.6°F]) | Do not refrigerate |
*Pump Reservoir: The total in use time is 28 days, including 6 days in the pump reservoir
**PumpCart Cartridges: The maximum time at room temperature is 18 days including 4 days in the pump
Storage of FIASP in Insulin Pump:
- •
- Change FIASP in the pump reservoir at least every 6 days or according to the pump user manual, whichever is shorter.
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- Replace the FIASP PumpCart cartridge at least every 4 days or according to the pump user manual, whichever is shorter.
- •
- Change FIASP to avoid insulin degradation or after exposure to temperatures that exceed 37°C (98.6°F).
- •
- The infusion set and infusion set insertion sites should be changed according to the manufacturers’ user manual.
Storage of FIASP in Intravenous Infusion Fluids:
Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature at 20°C to 25°C (68°F to 77°F) for 24 hours.
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