Once-daily Tresiba® has a flat and stable profile1-3

After steady state was reached, serum concentrations remained stable from day to day2,3


Relative serum trough concentrations of once-daily dosing in adults with type 1 diabetes2,3


Graph showing that, after Tresiba®, steady state is achieved after 3 to 4 days

Graph showing that, after Tresiba®, steady state is achieved after 3 to 4 days

Values are estimated ratios relative to day 10; clinical steady state is defined as >90% of the final plateau level.

  • The recommended time between dose increases is 3 to 4 days (the same amount of time it takes to reach steady state)1
  • Total and maximum exposure at steady state are comparable between Tresiba® U-100 and Tresiba® U-200, when each is administered at the same units/kg dose1

Heise et al PK/PD study2,3

Population: Adults with type 1 diabetes.

Study design: Randomized, double-blind, parallel-group, single-center trial evaluating the day-to-day activity and glucose-lowering effect of Tresiba® 100 units/mL (n=27) vs insulin glargine U-100 (n=27) under steady-state conditions. Patients received Tresiba® or insulin glargine U-100 (0.4 units/kg) once daily for 12 days. The euglycemic clamp was performed on days 6, 9, and 12 of treatment and blood samples were taken throughout each clamp period.

Primary endpoint: To evaluate the within-subject variability of the pharmacodynamic response between Tresiba® and insulin glargine U-100 based on the area under the glucose infusion rate curve (AUCGIR) during one dosing interval (0-24 hours) at steady state.

PD=pharmacodynamic.
PK=pharmacokinetic.   



Find out what clinical studies have shown about the efficacy and safety of Tresiba®

The only basal insulin proven to last at least 42 hours1,a


Duration of action of Tresiba®1


After Tresiba® injection, patients will experience at least a 42-hour (0.4 U/kg) duration of action

After Tresiba® injection, patients will experience at least a 42-hour (0.4 U/kg) duration of action
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    
 

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

In another study, a PK analysis was conducted for Tresiba® using data from 199 pediatric patients (1 to <18 years of age) with type 1 diabetes. Body weight was a significant covariate affecting the clearance of Tresiba®. After adjusting for body weight, the total exposure of Tresiba® at steady state was independent of age.



Review the pharmacokinetics and pharmacodynamics of Tresiba® with Dr Christopher Sorli and Dr Todd Hobbs, Chief Medical Officer, North America, at Novo Nordisk.


Dive deeper into Tresiba®



Once-daily Tresiba®:
A proven A1C descent1
See the mechanism of protraction video to find out how this basal insulin works

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. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Diabetes Obes Metab. 2012;14(9):859-864.
  3. Heise T, Korsatko S, Nosek L, et al. J Diabetes. 2016;8(1):132-138.