Start your patients on the road to treating diabetes with Tresiba® (insulin degludec)
Tresiba® is a long-acting basal insulin indicated to improve glycemic control in patients 1 year of age and older with diabetes.1
Discover what makes the Tresiba® molecule different
Tresiba® has proven efficacy and a demonstrated safety profile.
Coverage may have changed in your area, and more patients may be covered than you think. Check your local coverage.
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.
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
It’s time to have the conversation about insulin, risk factors of hypoglycemia, and safety outcomes data
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.
PRIMARY COMPOSITE 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
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 of Tresiba® when they sign up for the Tresiba® Savings Card.
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.
Get patients started on Tresiba®
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 adverse cardiovascular event (MACE)a: 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.
Indications and Usage for Tresiba® (insulin degludec) injection 100 U/mL, 200 U/mL
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 insulin degludec or any of the excipients in Tresiba®
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: Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, using drugs that block the sympathetic nervous system (e.g., beta-blockers) or who experience recurrent hypoglycemia. The long-acting effect of Tresiba® may delay recovery from hypoglycemia compared to shorter-acting insulins.
Risk Factors for Hypoglycemia: The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Tresiba® may vary among different patients or at different times in the same patients and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to concomitant drugs. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Patients and caregivers must be educated to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. - Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products have been reported. To avoid medication errors between Tresiba® and other insulins, always instruct patients to always check the insulin label before each injection. To avoid dosing errors and potential overdose, never use a syringe to remove Tresiba® from the Tresiba® FlexTouch® disposable insulin prefilled pen.
- Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Tresiba®. If hypersensitivity reactions occur, discontinue Tresiba®; treat per standard of care and monitor until symptoms and signs resolve.
- Hypokalemia: All insulins, including Tresiba®, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
- Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: 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 Tresiba® Prescribing Information.
References:
- Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.
- Heise T, Korsatko S, Nosek L, et al. J Diabetes. 2016;8(1):132-138.
- Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Diabetes Obes Metab. 2012;14(9):859-864.
- Marso SP, McGuire DK, Zinman B, et al. N Engl J Med. 2017;377(8):723-732.