Fiasp® was effective in lowering A1C1

Type 1 Diabetes icon

Demonstrated superior A1C reductions vs NovoLog® when dosed at mealtime1,2,a

onset 1 • 26 weeks, type 1 diabetes1

Adjusted change from baseline

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

Estimated treatment differences

Mealtime Fiasp® vs NovoLog®a:
–0.15% [95% CI, –0.23, –0.07]

Postmeal Fiasp® vs NovoLog®:
0.04% [95% CI, –0.04, 0.12]

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.


Type 2 Diabetes icon

Demonstrated superior A1C reductions when used in a basal/bolus regimen vs basal insulin1,3

onset 3 • 18 weeks, type 2 diabetes1

Adjusted change from baseline

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

Estimated treatment differences

Fiasp® + basal insulin vs basal insulin:
–0.94% [95% CI, –1.17, –0.72]

SUPERIOR REDUCTION

for Fiasp®
+ basal insulin
vs basal insulin
(P<0.0001)

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%.3

View the Fiasp® clinical trial safety results

Safety results1


onset 1 • 26 weeks, type 1 diabetes

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

onset 3 • 18 weeks, type 2 diabetes

  • Proportion (%) of patients experiencing at least 1 episode of severe hypoglycemia3,b: 2.6%

Adverse events occurring in 5% of patients includedc:

  • 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.

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 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 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 3 (Study C) Study Design1,3:

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 or without other oral antidiabetic therapy, for at least 3 months. Patients were randomized to either mealtime Fiasp® in addition to basal insulin (n=116) and metformin or to continuing basal insulin and metformin therapy without Fiasp® (n=120). The basal insulins used in both treatment arms were insulin glargine, 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 a pen or a vial for administration

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 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 insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased.

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 adults 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 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 insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased.
  • 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.

Adverse Reactions

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

Use in Specific Populations

  • The safety and effectiveness of Fiasp® in pediatric patients have not been established.
  • 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. 
  • Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased. 
  • 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; September 2017.
  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. 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.