Once-daily Tresiba®

Powerful A1C and fasting plasma glucose (FPG) reductions in a 52-week study in adults with type 1 diabetes1



A1C reductions observed in BEGIN: Basal-Bolus Type 11


Tresiba®: A1C reduction chart in Type 1 Diabetes patients

Tresiba®: A1C reduction chart in Type 1 Diabetes patients

  • In this treat-to-target trial, Tresiba® and insulin glargine U-100 produced similar A1C reductions (–0.36% vs –0.34%, respectively)
    • Baseline: Tresiba®, 7.7%; insulin glargine U-100, 7.7%
    • End of trial: Tresiba®, 7.3%; insulin glargine U-100, 7.3%
  • At week 52, the difference in A1C reduction from baseline between Tresiba® and insulin glargine U-100 was –0.01% (95% CI, -0.14% to 0.11%) and met the prespecified noninferiority margin (0.4%)


FPG reductions observed in BEGIN: Basal-Bolus Type 11


Tresiba®: FPG reduction chart in Type 1 Diabetes patients

Tresiba®: FPG reduction chart in Type 1 Diabetes patients

  • Tresiba® and insulin glargine U-100 produced similar FPG results in this trial: Tresiba®, –27.6 mg/dL; insulin glargine U-100, –21.6 mg/dL
    • Baseline: Tresiba®, 165 mg/dL; insulin glargine U-100, 174 mg/dL
    • End of trial: Tresiba®, 141 mg/dL; insulin glargine U-100, 149 mg/dL


Tresiba® safety results: type 1 diabetes1


  • In the BEGIN: Basal-Bolus Type 1 trial, the percent of patients who experienced at least 1 episode of hypoglycemia was 12.3% for severe hypoglycemiab and 95.6% for Novo Nordisk–defined hypoglycemiac
  • Incidence rates of hypoglycemia in all type 1 diabetes trials ranged from 10.4% to 12.7% for severe hypoglycemiab and 93.0% to 99.4% for Novo Nordisk–defined hypoglycemiac

bSevere hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

cNovo Nordisk–defined hypoglycemia: a severe hypoglycemia event or an event where laboratory or self-measured glucose calibrated to plasma was <56 mg/dL or where whole blood glucose was <50 mg/dL (ie, with or without the presence of hypoglycemic symptoms).


BEGIN: Basal-Bolus Type 11,2

Population: Adults with type 1 diabetes.

Study design: 52-week, randomized, open-label, multicenter trial comparing the efficacy and safety of once-daily Tresiba® U-100 (n=472) and once-daily insulin glargine U-100 (n=157). Insulin aspart was administered before each meal in both treatment arms. Basal insulin was titrated to an FPG target of 70 to 90 mg/dL according to mean prebreakfast self-measured plasma glucose (SMPG) values (mean of 3 consecutive days). Bolus insulin was titrated to preprandial (of next meal) and bedtime SMPG concentrations of 70 to 90 mg/dL.    

Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.

Mean end-of-trial basal insulin dose: Tresiba®, 29 units; insulin glargine U-100, 31 units.

End-of-trial daily bolus insulin dose: Tresiba® arm: Tresiba®, 29 units; insulin aspart, 32 units; insulin glargine U-100 arm: insulin glargine, 31 units; insulin aspart, 35 units.



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Eligible patients pay as little as $15 per prescriptiona

aFor up to 24 months. Maximum savings of $500 per prescription. Eligibility and other restrictions apply.



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Give patients a glucose-lowering effect of at least 42 hours1,d
Guides to help parents and their children manage diabetes

Adult patients who miss a dose of Tresiba® should inject their daily dose during waking hours upon discovering the missed dose, then continue with their regular dosing schedule. Ensure that at least 8 hours have elapsed between Tresiba® injections.1    

dAfter the last of 8 once-daily injections (0.4 units/kg).

Selected Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens
  • Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening

Indications and Usage

Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of Tresiba®.

Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens
  • Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection
  • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba®
  • As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of 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 Tresiba®. 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 commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain

Drug Interactions

  • Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine)

Please click here for Prescribing Information.

 

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2016.
  2. Heller S, Buse J, Fisher M, et al; on behalf of the BEGIN Basal-Bolus Type 1 Trial Investigators. Lancet. 2012;379(9825):1489-1497.