Fiasp® was effective in lowering A1C1

Safety Results Below

Fiasp® was effective in lowering A1C1

Safety Results Below
Type 1 Diabetes icon

Demonstrated A1C reductions when dosed at mealtime or postmeal1

onset 1 • 26 weeks, adults with type 1 diabetes

A1C reductions vs NovoLog® (insulin aspart injection) 100 U/mL (adjusted change from baseline)1,2,a

Fiasp® vs NovoLog® mealtime dosing A1C reductions
Fiasp® postmeal dosing A1C reductions

Baseline A1C for both Fiasp® arms was 7.6% with an end-of-trial A1C of 7.3% for mealtime Fiasp® + insulin detemir and 7.5% for postmeal Fiasp® + insulin detemir. The baseline A1C for NovoLog® + insulin detemir was 7.6% with an end-of-trial A1C of 7.4%.2

aPrimary outcome was tested for noninferiority. Superiority could not be confirmed, as this was not part of the hierarchical testing procedure.

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primary_msg

Results are from a 26-week randomized, active-controlled, treat-to-target, multicenter trial in 1143 adult patients with type 1 diabetes comparing Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog®.

Type 1 Diabetes icon
In adults with T1D

Proven A1C reductions when added to insulin degludec3

onset 8 • 26 weeks, adults with type 1 diabetes

A1C reductions when added to insulin degludec vs NovoLog® (insulin aspart injection) 100 U/mL (adjusted change from baseline)3

Fiasp® vs NovoLog® mealtime dosing A1C reductions when added to insulin degludec
Fiasp® + insulin degludec U-100 (mealtime) (0.2 U/kg dose)
Fiasp® + insulin degludec U-100 (postmeal) (0.2 U/kg dose)
NovoLog® + insulin degludec U-100 (insulin aspart injection) 100 U/mL (mealtime) (0.2 U/kg dose)

Baseline A1C for mealtime Fiasp® + insulin degludec was 7.5%, with an end-of-trial A1C of 7.3%. Baseline A1C for postmeal Fiasp® + insulin degludec was 7.4%, with an end-of-trial A1C of 7.4%. The baseline A1C for NovoLog® + insulin degludec was 7.4%, with an end-of-trial A1C of 7.3%.3 

Mealtime is defined as injection 0-2 minutes before the start of a meal.
Postmeal dosing was defined as injection at the end of the meal, no later than 20 minutes after the start of the meal.
T1D=type 1 diabetes; CI=confidence interval.

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primary_msg

Results are from a 26-week randomized, active-controlled, treat-to-target, multicenter trial in 1025 adult patients with type 1 diabetes comparing Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog®.

Type 2 Diabetes icon

Demonstrated superior A1C reductions vs basal insulin alone1,4

onset 3 • 18 weeks, adults with type 2 diabetes

A1C reductions when used in a basal/bolus regimen vs basal insulin (adjusted change from baseline)1,4

Mealtime dosing A1C reductions from Fiasp® plus basal insulin vs basal insulin alone

Baseline A1C for Fiasp® + basal insulin + MET was 7.9% with an end-of-trial A1C of 6.8%. The baseline A1C for basal insulin + MET was 7.9% with an end-of-trial A1C of 7.7%.4

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secondary_msg

Results are from an 18-week randomized, open-label, parallel group trial in 236 adult patients with type 2 diabetes comparing mealtime Fiasp® plus basal insulin vs basal insulin alone.

View the Fiasp® clinical trial safety results

Safety results1

onset 1 • 26 weeks, adults with type 1 diabetes

  • Proportion (%) of patients experiencing at least 1 episode of severe hypoglycemia2,b:
    Mealtime Fiasp® + insulin detemir: 6.7%; postmeal Fiasp® + insulin detemir: 8.0%

onset 8 • 26 weeks, adults with type 1 diabetes

  • Proportion (%) of patients experiencing at least 1 episode of severe hypoglycemia3,b:
    mealtime Fiasp® + insulin degludec, 9.4%;postmeal Fiasp® + insulin degludec, 5.6%

onset 3 • 18 weeks, adults with type 2 diabetes

  • Proportion (%) of patients experiencing at least 1 episode of severe hypoglycemia4,b: 2.6%

Adverse events occurring in ≥5% of adult patients1,c (mealtime; postmeal included):

  • Type 1 diabetes (mealtime; postmeal): nasopharyngitis (20.2%; 23.9%), upper respiratory tract infection (9.1%; 7.4%), nausea (4.9%; 5.0%), diarrhea (5.4%; 3.2%), and back pain (5.2%; 4.0%)
  • Type 2 diabetes: urinary tract infection (5.9%)

bSevere hypoglycemia (ADA classification): an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
cIncidence ≥5% and occurring at the same rate or greater with Fiasp® than comparator.

tertiary_msg

onset 1 (Study A) Study Design1,2:

Population: Adults with type 1 diabetes.

Study Design: 26-week, randomized, active-controlled, treat-to-target, multicenter trial in 1143 adult patients with type 1 diabetes inadequately controlled at baseline (A1C of 7.0%-9.5%) who were on basal/bolus insulin therapy for at least 12 months. Patients were randomized to either blinded mealtime Fiasp® (n=381), blinded mealtime NovoLog® (n=380), or open-label postmeal Fiasp® (n=382), all in combination with once- or twice-daily insulin detemir. At randomization, patients in Fiasp® arms were switched to Fiasp® on a unit-to-unit basis from their pretrial bolus insulin. Mealtime Fiasp® or NovoLog® was injected 0-2 minutes before the meal, and postmeal Fiasp® was injected 20 minutes after the start of the meal.

Primary endpoint: Change in A1C from baseline after 26 weeks of treatment. Noninferiority of Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog® was confirmed.

onset 8 Study Design1,3:

Population: Adults with type 1 diabetes.

Study Design: 26-week, randomized, active-controlled, treat-to-target, multicenter trial in 1025 adult patients with type 1 diabetes inadequately controlled at baseline (A1C of 7.0−9.5%) who were on basal-bolus insulin therapy for at least 12 months. Patients were randomized to either blinded mealtime Fiasp® (n=342), blinded mealtime NovoLog® 100 U/mL (n=342), or open-label postmeal Fiasp® (n=341), all in combination with once-daily insulin degludec. At randomization, patients in Fiasp® arms were switched to Fiasp® on a unit-to-unit basis from their pretrial bolus insulin. Mealtime Fiasp® or NovoLog® was injected 0–2 minutes before the meal, and postmeal Fiasp® was injected at the end of the meal, no later than 20 minutes after the start of the meal.

Primary Endpoint: Change in A1C from baseline after 26 weeks of treatment. Noninferiority of Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog® was confirmed.

onset 3 (Study C) Study Design1,4:

Population: Adults with type 2 diabetes.

Study Design: 18-week randomized, open-label, parallel group trial in 236 adult patients with type 2 diabetes who were inadequately controlled at baseline who were on basal insulin and metformin therapy, either with (A1C 7.5%-9.0%) or without (A1C 7.5%-9.5%) other oral antidiabetic therapy, for at least 3 months. Patients were randomized to either mealtime Fiasp® in addition to basal insulin (n=116) or to continuing basal insulin and metformin therapy without Fiasp® (n=120). The basal insulins used in both treatment arms were insulin glargine U-100, insulin detemir, or NPH. All patients were also required to be on ≥1000 mg metformin treatment at baseline. Mealtime Fiasp® was injected 0-2 minutes before the meal.

Primary endpoint: Change in A1C from baseline after 18 weeks of treatment. Superiority of Fiasp® when used in a basal/bolus regimen vs basal insulin was confirmed.

Choose between pen, vial, or cartridge for administration

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Selected Important Safety Information

Contraindications

  • Fiasp® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Fiasp® or one of its excipients.

Warnings and Precautions

  • Never share a Fiasp® FlexTouch® Pen, PenFill® cartridge or PenFill® cartridge device between patients, even if the needle is changed. Patients using Fiasp® vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.

Fiasp® (insulin aspart injection) 100 U/mL Indications and Usage

Fiasp® (insulin aspart injection) 100 U/mL is a rapid-acting insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Important Safety Information

Contraindications

  • Fiasp® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Fiasp® or one of its excipients.

Warnings and Precautions

  • Never share a Fiasp® FlexTouch® Pen, PenFill® cartridge or PenFill® cartridge device between patients, even if the needle is changed. Patients using Fiasp® vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia is the most common adverse reaction of insulin, including Fiasp®, and may be life-threatening. Increase glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.
  • To avoid medication errors and accidental mix-ups between Fiasp® and other insulin products, instruct patients to always check the insulin label before injection.
  • As with all insulins, Fiasp® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
  • Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including Fiasp®.
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Fiasp®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
  • Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous injection of Fiasp® may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Adverse Reactions

  • Adverse reactions observed with Fiasp® include hypoglycemia, allergic reactions, hypersensitivity, injection site reactions, lipodystrophy, and weight gain.

Use in Specific Populations

  • Pediatric patients with type 1 diabetes treated with mealtime and postmeal Fiasp® reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog® (insulin aspart injection); the imbalance was greater during the nocturnal period. Monitor blood glucose levels closely in pediatric patients.
  • Like all insulins, Fiasp® requirements may be reduced in patients with renal impairment or hepatic impairment. These patients may require more frequent blood glucose monitoring and dose adjustments.

Please click here for Prescribing Information.

 

NovoLog® (insulin aspart injection) 100 U/mL Indications and Usage

NovoLog® (insulin aspart injection) 100 U/mL is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Important Safety Information

Contraindications

  • NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients.

Warnings and Precautions

  • Never Share a NovoLog® FlexPen, NovoLog® FlexTouch®, PenFill® Cartridge, or PenFill® Cartridge Device Between Patients, even if the needle is changed. Patients using NovoLog® vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia is the most common adverse effect of insulin therapy. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy.
  • To avoid medication errors and accidental mix-ups between NovoLog® and other insulin products, instruct patients to always check the insulin label before injection.
  • Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog®.
  • As with all insulins, NovoLog® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including NovoLog®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
  • Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

NovoLog® continuous subcutaneous infusion route (insulin pump): Do not mix NovoLog® with any other insulin or diluent.

Adverse Reactions

  • Adverse reactions observed with NovoLog®include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.

Use in Specific Populations

  • NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age.
  • Like all insulins, NovoLog® requirements may be reduced in patients with renal impairment or hepatic impairment. These patients may require more frequent blood glucose monitoring and dose adjustments.

Please click here for Prescribing Information.

 

References:

  1. Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2019.
  2. Russell-Jones D, Bode BW, De Block C, et al. Fast-acting insulin aspart improves glycemic control in basal–bolus treatment for type 1 diabetes: results of a 26-week multicenter, active-controlled, treat-to-target, randomized, parallel-group trial (onset 1). Diabetes Care. 2017:40(7):943-950.
  3. Buse JB, Carlson AL, Komatsu M, et al. Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab. 2018;20(12):2885-2893.
  4. Rodbard HW, Tripathy D, Vidrio Velázquez M, Demissie M, Tamer SC, Piletič M. Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: a randomized, 18-week, open-label, phase 3 trial (onset 3). Diabetes Obes Metab. 2017;19(10):1389-1396.

 

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