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. Sharing poses a risk for transmission of blood-borne pathogens.
  • Administration: NovoLog® should generally be given immediately (within 5-10 minutes) prior to the start of a meal. Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. As with all insulin preparations, the time course of action of NovoLog® may vary in different individuals or at different times in the same individual and is dependent on many conditions, including injection site, local blood supply, temperature, and level of physical activity. NovoLog® should be used with a longer-acting insulin.

NovoLog® (insulin aspart [rDNA origin] injection) Indications and Usage

  • NovoLog® (insulin aspart [rDNA origin] injection) 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. Sharing poses a risk for transmission of blood-borne pathogens.
  • Administration: NovoLog® should generally be given immediately (within 5-10 minutes) prior to the start of a meal. Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. As with all insulin preparations, the time course of action of NovoLog® may vary in different individuals or at different times in the same individual and is dependent on many conditions, including injection site, local blood supply, temperature, and level of physical activity. NovoLog® should be used with a longer-acting insulin.
  • Hypoglycemia: 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. Any change of insulin dose should be made cautiously and only under medical supervision.
  • Hypokalemia: Insulin, particularly when given intravenously or in settings of poor glycemic control, can cause hypokalemia. Use caution in patients predisposed to hypokalemia.
  • Renal and Hepatic Impairment: Like all insulins, NovoLog® requirements may be reduced in patients with renal impairment or hepatic impairment.
  • Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog®
  • Continuous Subcutaneous Insulin Infusion by External Pump: When used in an external subcutaneous insulin infusion pump, NovoLog® should not be mixed with any other insulin or diluent.
  • Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: 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.

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.
  • The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia.

Please click here for Prescribing Information.