NovoLog® helps lower A1C levels1,2

NovoLog® has been studied in multiple approaches demonstrating insulin intensification. Results of the two studies, described below, show that NovoLog® helps lower A1C levels.1,2

The FullSTEP® Study

A manageable, patient-titrated approach for glycemic control.

NovoLog® dosed in a stepwise approach was just as efficacious as full basal-bolus at study end.1

In the FullSTEP® study, patients uncontrolled on basal insulin with or without OADs were randomized to either a stepwise approach or a full basal-bolus dosing arm. In the stepwise arm, patients added NovoLog® to their basal insulin at the patient-perceived largest meal of the day. After 11 weeks and 22 weeks, additional doses of NovoLog® were added, if A1C was ≥ 7%, to the next largest patient-perceived largest meals. In the full basal-bolus arm, NovoLog® was added at all 3 main meals from the start. The study found that similar A1C and FPG results were demonstrated by study end when NovoLog® was initiated with 1 dose (stepwise arm) or 3 doses (full basal-bolus arm) (A1C. P=0.088; FPG. P=0.64)1

 

A1C reductions over 32 weeks with basal insulin plus NovoLog® in the stepwise approach versus the full basal-bolus approach

Chart showing a1c reduction with basal insulin plus NovoLog® vs full basal bolus approach


Rodbard et al (FullSTEP®)
, a randomized, open-label, multinational, non-inferiority, 32-week treat-to-target trial. Patients with type 2 diabetes inadequately controlled on basal insulin with or without OADs were randomized to either a stepwise arm or full basal-bolus arm. In the stepwise arm (n=201), NovoLog® (insulin aspart [rDNA origin] injection) was added to basal insulin at the patient-perceived largest meal initially. Additional doses were added to the next largest patient-perceived largest meal at weeks 11 and 22 if A1C ≥7%. In the full basal-bolus arm (n=200), NovoLog® was added at all 3 main meals from the start. Patients in both arms self-titrated NovoLog® daily based on the previous day's premeal or bedtime self-measured plasma glucose levels.

Adapted from Rodbard et al 20131


 

Mean total daily doses at the end of study in the stepwise arm

Chart showing daily doses in the stepwise arm of NovoLog® and Levemir®

Even in patients with long-standing diabetes (>12 years), starting with only 1 dose of NovoLog® led to glycemic goal


 

A practical, patient-led approach to achieving glycemic control - 1 meal at a time1

The FullSTEP® study afforded patients a manageable approach to gain better control of type 2 diabetes. Starting with just 1 dose at their largest meal of the day to fit their daily routine, the FullSTEP® study enabled patients to take mealtime insulin initation 1 step at a time.a

Compared with full basal-bolus, the stepwise arm offered patients the potential of:1

  • Fewer injections every day
  • Fewer daily SMPG readings

Glucose monitoring is recommended for all patients with diabetes and management care plans should be individualized.

Infographic showing percentage of patients continuing on therapy

a Patients determined their largest meal of the day based on highest estimated carbohydrate intake.

b This was a 32-week study. In the stepwise arm (n=201), NovoLog® was added to basal insulin at the patient-perceived largest meal initially. In the full basal-bolus arm (n=200), NovoLog® was added at all 3 main meals from the start. Significantly more patients in the full basal-bolus arm (n=52) withdrew vs the stepwise arm (n=28) (P=0.002). There were no serious adverse events that led to withdrawal. Withdrawal criteria included: pregnancy or intention of becoming pregnant, hypoglycemia that posed a safety problem, major protocol deviation having influence on efficacy or safety data, and initiation or change in systemic treatment.

SMPG = self-measured plasma glucose


 

Safety and FullSTEP®

The FullSTEP® study also showed significantly fewer hypoglycemic events with the stepwise approach vs full basal-bolus


 



 

Dosing and FullSTEP®

The FullSTEP® patient-titrated dosing approach fostered patients' active involvement5


 



 

The FullSTEP® Study

Watch Dr. Helena Rodbard, MD, discuss the results of the FullSTEP® study


 


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. 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.

 

References

  1. 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.
  2. Holman RR, Farmer AJ, Davies MJ, et al; for the 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361(18):1736-1747.
  3. Holman RR, Thorne KI, Farmer AJ, et al; for the 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007;357(17):1716-1730.