Tresiba® had 4X less within-subject day-to-day variability vs insulin glargine U-1001,2,a

Calculated using the glucose infusion rate (GIR) profiles of adults with type 1 diabetes (P<0.0001)

One dosing interval (0-24 h) at steady state


Clinical Dosing Chart

Clinical Dosing Chart

AUCGIR,0-24h,SS=area under the GIR curve from 0 to 24 hours at steady state; CV=coefficient of variation.

aSteady state achieved after 3 to 4 days.



Flat and stable profile

Discover how once-daily Tresiba® has a flat and stable profile.1-3


Tresiba® had less within-subject day-to-day variability when evaluated every 2 hours vs insulin glargine U-1001

Post hoc analysis: Calculated using the GIR profiles of adults with type 1 diabetes


2-hour intervals at steady state


Duration of Action Chart

Duration of Action Chart

AUCGIR,0-24h,SS=area under the GIR curve from 0 to 24 hours at steady state; CV=coefficient of variation.

The clinical significance of these PK/PD differences has not been established.


PK/PD Study 11,2

Population: Adults with type 1 diabetes.

Study design: Randomized, double-blind, parallel-group, single-center trial evaluating the day-to-day within-subject activity and glucose-lowering effect of basal insulin Tresiba® U-100 (n=27) vs insulin glargine U-100 (n=27) under steady-state conditions. Patients received Tresiba® (insulin degludec injection 100 U/mL) U-100 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 PD response between basal insulin Tresiba® U-100 and insulin glargine U-100 based on the area under the glucose infusion rate curve (AUCGIR) during 1 dosing interval (0-24 hours) at steady state.

PD=pharmacodynamic.
PK=pharmacokinetic.   

“For patients who could benefit from a long duration of action, I would prescribe Tresiba®.”

-Dr James R. Gavin, III, former president, American Diabetes Association (ADA)



Dive deeper into Tresiba®


42+ hour duration of action that won’t taper off at the end of the day3,b

See what to do when patients miss their scheduled dose of Tresiba®

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.

bAfter 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. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Diabetes Obes Metab. 2012;14(9):859-864.
  2. Heise T, Korsatko S, Nosek L, et al. J Diabetes. 2016;8(1):132-138.
  3. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2016.