Effective for pump use in children 2 years and older

NovoLog® is safe and effective in helping patients reach age-specific A1C goals1

The data shown below are from a study of NovoLog® (insulin aspart injection) 100 U/mL vs insulin lispro for pediatric pump use in type 1 diabetes. Patients were between 4 and 18 years old, and A1C goals were based on age,a in alignment with American Diabetes Association guidelines.1 At the end of the 16-week study, almost 60% of patients were at their A1C goal, compared to almost 44% with insulin lispro.

 

A1C goal attainment: NovoLog® vs insulin lisproa

chart showing difference of baseline NovoLog® vs insulin lispro

A 16-week, open-label, multicenter, parallel-group study enrolling 298 patients with type 1 diabetes aged 3 to 18 years. The efficacy and safety of NovoLog® CSII therapy were compared with those of insulin lispro. Although patients as young as 3 years were eligible for inclusion, the youngest child included in the study was aged 4 years.1

aAge-specific A1C goals were defined as <8.5% for patients aged <6 years and <8% for patients aged 6 to 18 years.

Adapted from Weinzimer et al, 2008.1
 

  • Overall efficacy was comparable
  • NovoLog® reduced A1C by 0.15% from baseline compared with 0.05% with insulin lispro
  • Rates of minor, major, and nocturnal hypoglycemic events were similar for both treatment groups


 

Mean weight-adjusted daily dose at study end1

In the same study, patients using NovoLog® also required significantly lower daily dosing at week 16 than patients taking insulin lispro 0.86 units/kg/day for NovoLog® vs 0.94 units/kg/day for insulin lispro, (P=0.018).1

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.

See full study design above.

 



 

Safe for pump use in children 2 years and older1

Similar rates of hypoglycemic events and infusion site reactions were shown with NovoLog® and insulin lispro.


 


Related Efficacy Topics:

Selected 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.

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. Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008;31(2):210-215.
  2. American Diabetes Association. Standards of medical care in diabetes–2013. Diabetes Care. 2013; Jan;36 Suppl 1: S11-66.