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The DEVOTE trial examined the risk of MACEa and the rate of severe hypoglycemia1-3

DEVOTE is the first safety outcomes trial evaluating the noninferiority in risk of major adverse cardiovascular events (MACE) with Tresiba® U-100 vs insulin glargine U-100 in adults with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD).1-3 DEVOTE also evaluated, as secondary endpoints, the rate and incidence of severe hypoglycemia vs. insulin glargine U-100.1,3

Tresiba® is a long-acting basal insulin indicated to improve glycemic control in patients with diabetes.1


Are your patients at a higher risk for hypoglycemia? See risk factors »


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DEVOTE studied adult patients with type 2 diabetes and ASCVD:

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.1

The DEVOTE trial examined the risk of MACEa and the rate of severe hypoglycemia1-3

DEVOTE is the first safety outcomes trial evaluating the noninferiority in risk of major adverse cardiovascular events (MACE) with Tresiba® U-100 vs insulin glargine U-100 in adults with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD).1-3 DEVOTE also evaluated, as secondary endpoints, the rate and incidence of severe hypoglycemia vs. insulin glargine U-100.1,3

Tresiba® is a long-acting basal insulin indicated to improve glycemic control in patients with diabetes.1


Are your patients at a higher risk for hypoglycemia? 
See risk factors »






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 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 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, pramlinitide, 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; March 2018.
  2. Novo Nordisk (press release). June 12, 2017. http://press.novonordisk-us.com/2017-06-12-Tresiba-R-demonstrated-no-increased-risk-of-major-cardiovascular-events-and-significant-reduction-in-rates-of-severe-hypoglycaemia-compared-to-insulin-glargine-U100-in-the-DEVOTE-trial. Accessed March 26, 2018.
  3. Marso SP, McGuire DK, Zinman B, et al. N Engl J Med. 2017;377(8):723-732.