NovoLog® Clinical Studies

The links below will provide you access to the published clinical data on PubMed.gov, the website of the US National Library of Medicine, National Institutes of Health.

Type 2

<strong>Rodbard et al 2014</strong> (FullSTEP<sup>®</sup>)

Rodbard et al 2014 (FullSTEP®)

Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DHW. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol. 2014;2:30-37.
<strong>Holman et al 2009</strong> (3-year results from 4-T intensification study)

Holman et al 2009 (3-year results from 4-T intensification study)

Holman RR, Farmer AJ, Davies MJ, et al; 4-T Study Group. N Engl J Med. 2009;361(18):1736-1747.
<strong>Liebl et al 2009</strong> (PREFER: NovoLog<sup>®</sup> + insulin detemir as basal-bolus vs biphasic insulin aspart)

Liebl et al 2009 (PREFER: NovoLog® + insulin detemir as basal-bolus vs biphasic insulin aspart)

Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B, for the PREFER Study Group. Diabetes Obes Metab. 2009;11(1):45-52.
<strong>Holman et al 2007</strong> (First-year results from 4-T intensification study)

Holman et al 2007 (First-year results from 4-T intensification study)

Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group. N Engl J Med. 2007;357(17):1716-30.

Type 1

<strong>van Bon et al 2011</strong> (NovoLog<sup>®</sup> vs glulisine and lispro in CSII)

van Bon et al 2011 (NovoLog® vs glulisine and lispro in CSII)

van Bon AC, Bode BW, Sert-Langeron C, Devries JH, Charpentier G. Diabetes Technol Ther. 2011;13(6):607-614.
<strong>Weinzimer et al 2008</strong> (CSII, NovoLog<sup>®</sup> vs lispro in pediatric patients)

Weinzimer et al 2008 (CSII, NovoLog® vs lispro in pediatric patients)

Weinzimer SA, Temand C, Howard C, et al; Insulin Aspart Pediatric Pump Study Group. Diabetes Care. 2008;31(2):210-215.
<strong>Heller et al 2004</strong> (Basal-bolus with NPH)

Heller et al 2004 (Basal-bolus with NPH)

Heller SR, Colagiuri S, Vaaler S, et al. Diabet Med. 2004;21:769-775.
<strong>Bode et al 2002</strong> (NovoLog<sup>®</sup> vs lispro vs buffered RHI in CSII)

Bode et al 2002 (NovoLog® vs lispro vs buffered RHI in CSII)

Bode B, Weinstein R, Bell D, et al. Diabetes Care. 2002;24:439-444.
<strong>Raskin et al 2000</strong> (NovoLog<sup>®</sup> + NPH vs RHI + NPH)

Raskin et al 2000 (NovoLog® + NPH vs RHI + NPH)

Raskin P, Guthrie RA, Leiter L, Riis A, Jovanovic L. Diabetes Care. 2000;23(5):585-588.
<strong>Lindholm et al 1999</strong> (NovoLog<sup>®</sup> vs RHI)

Lindholm et al 1999 (NovoLog® vs RHI)

Lindholm A, McEwen J, Riis AP. Diabetes Care. 1999;22(5);801-805.

RHI= regular human insulin; CSII= continuous subcutaneous insulin infusion (insulin pump).
Buffered regular human insulin is no longer manufactured in the United States.

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.