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Start your patients on the road to treating diabetes with Tresiba®

Get prescribing info

Discover what makes the Tresiba® molecule different

Tresiba® is a long-acting insulin with proven efficacy and a demonstrated safety profile.

Coverage may have changed in your area, and more patients may be covered than you think.

Clinical features ▾

DEVOTE study data ▾

Savings and co-pay ▾

Start your patients on the road to treating diabetes with Tresiba®

Get prescribing info

Discover what makes the Tresiba® molecule different

Tresiba® is a long-acting insulin with proven efficacy and a demonstrated safety profile.

Coverage may have changed in your area, and more patients may be covered than you think.

Clinical features ▾

DEVOTE study data ▾

Savings and co-pay ▾

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The Tresiba® molecule is different by design

The molecular design of Tresiba® provides a steady rate of absorption into the bloodstream, giving it a flat and stable profile.1-3 This slow and steady release allows for around-the-clock glycemic control.

See clinical features

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The recommended time between dose increases is 3 to 4 days (the same amount of time it takes to reach steady state).1

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

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It’s time to have the conversation about insulin and the risks of hypoglycemia

Patients starting on basal insulin may experience hypoglycemia without even understanding what is happening. View some of the risk factors of hypoglycemia, and share this information with your patients as you discuss the signs and symptoms.

For your insulin-naïve patients, consider the results of the DEVOTE study, a landmark safety outcomes trial for adults with type 2 diabetes (T2D) and ASCVD.

Patients starting on basal insulin may experience hypoglycemia without even understanding what is happening. View some of the risk factors of hypoglycemia, and share this information with your patients as you discuss the signs and symptoms.

For your insulin-naïve patients, consider the results of the DEVOTE study, a landmark safety outcomes trial for adults with type 2 diabetes (T2D) and ASCVD.

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PRIMARY ENDPOINT

MACE: Noninferiority

Tresiba® U-100 demonstrated no increased risk of major adverse cardiovascular events (MACE) vs insulin glargine U-100 for adults with T2D and ASCVD.4,a

PRIMARY ENDPOINT

MACE: Noninferiority

Tresiba® U-100 demonstrated no increased risk of major adverse cardiovascular events (MACE) vs insulin glargine U-100 for adults with T2D and ASCVD.4,a

SECONDARY ENDPOINT

Significantly lower rates of severe hypoglycemia

The secondary confirmatory endpoint showed Tresiba® U-100 also demonstrated significantly lower rates of severe hypoglycemic events vs insulin glargine U-100.4,b

Explore DEVOTE data


See study design below.

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“The safety outcomes data and other differentiating factors solidified Tresiba® as my go-to basal insulin for patients with type 2 diabetes. I also discuss Tresiba® with my colleagues and encourage them to prescribe Tresiba® for their appropriate patients.”

PHILIP WOODHAM, MD

Endocrinologist
Hackensack, NJ

Help patients navigate savings and coverage options

Your eligiblec patients pay as little as $25 or no more than $99 per prescription when they sign up for the Tresiba® Savings Card.

Get savings details

NovoCare® is a resource destination for HCPs and patients to find information on all Novo Nordisk patient access and support programs, including a tool to check estimated cost and coverage for individual patients.

Check patient costs

cEligibility and other restrictions apply.

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Study design
DEVOTE4

Population: Adult patients with T2D and ASCVD.

Study design: Treat-to-target, randomized, double-blind, active comparator-controlled, event-driven cardiovascular outcomes trial assessing the noninferiority of once-daily Tresiba® U-100 (n=3818) and once-daily insulin glargine U-100 (n=3819) in terms of the incidence of cardiovascular events.

Primary composite endpoint: Time from randomization to first occurrence of an adjudicated major cardiovascular event (MACE): cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Secondary confirmatory endpoints: The number and incidence of adjudicated events of severeb hypoglycemia, as defined in 2013 by the American Diabetes Association.

aMACE=cardiovascular death, nonfatal MI, or nonfatal stroke. 

bSevere hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions and during which plasma glucose concentration may not have been available, but where neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration.

ASCVD=atherosclerotic cardiovascular disease.

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, Needle, or Syringe Between Patients, even if the needle is changed. Patients using Tresiba® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant 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.

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, Needle, or Syringe Between Patients, even if the needle is changed. Patients using Tresiba® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant 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

  • There are certain drugs that may cause clinically significant drug interactions with Tresiba®.
    • Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors
    • Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
    • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
    • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine

Please click here for Prescribing Information

 

 

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.
  2. Heise T, Korsatko S, Nosek L, et al. J Diabetes. 2016;8(1):132-138. 
  3. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Diabetes Obes Metab. 2012;14(9):859-864.
  4. Marso SP, McGuire DK, Zinman B, et al. N Engl J Med. 2017;377(8):723-732.