When starting a patient with diabetes on basal insulin

The risk of hypoglycemia is an important safety consideration

"Hypoglycemia should be avoided in older adults with diabetes. It should be assessed and managed by adjusting glycemic targets and pharmacologic interventions."1  –American Diabetes Association. Standards of Medical Care in Diabetes—2019.

"Hypoglycemia should be avoided in older adults with diabetes. It should be assessed and managed by adjusting glycemic targets and pharmacologic interventions."1  
–American Diabetes Association. Standards of Medical Care in Diabetes—2019.


Hypoglycemia may be happening more often than you think

Many patients with hypoglycemic events are asymptomatic2

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Type 2 diabetes (T2D)

In a study of patients with T2D (n=30),

Type 2 diabetes patients with unrecognized hypoglycemia statistic

had unrecognized hypoglycemia as measured by CGMS

Type 1 diabetes (T1D)

In a study of patients with T1D (n=40),

Type 1 diabetes patients with unrecognized hypoglycemia statistic

had unrecognized hypoglycemia as measured by CGMS

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Talk to your patients about hypoglycemia, and let them know about the risk factors below

Common risk factorsa

  • Diabetes treatment (both secretagogues and insulin)3
  • Older age1
  • Long duration of diabetes4
  • Impaired renal function3


aDoes not include all factors that may increase a patient with diabetes’ risk for hypoglycemia.

Medications for cardiovascular conditions may impact hypoglycemia

May increase the risk of hypoglycemia3

  • ACE inhibitors
  • Angiotensin II receptor blocking agents

May mask the signs and symptoms of hypoglycemia3

  • Beta blockers
  • Clonidine
Study design
Chico et al study2

Population: Adult patients with type 1 and type 2 diabetes.

Study design: 105 patients with diabetes were included: 75 with type 1 diabetes and 30 with type 2 diabetes. Patients with inadequately controlled type 1 diabetes were randomly assigned to 1 of 2 glucose monitoring systems: 1) a group monitored with a CGMS, or 2) a group that used frequent capillary glucose measurements (the control group).

Study objective: To evaluate the incidence of unrecognized hypoglycemia (glucose value <60 mg/dL) in patients with type 1 and type 2 diabetes, using CGMS.  

Safety outcomes trial for adults with T2D and ASCVD

See how Tresiba® U-100 compares with insulin glargine U-100 in risk of MACEb and rate of severe hypoglycemiac

See DEVOTE data

bMACE=cardiovascular death, nonfatal MI, or nonfatal stroke. 
cSevere 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; CGMS=continuous glucose monitoring system; T2D=type 2 diabetes.

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. American Diabetes Association. Diabetes Care. 2019;42(Suppl 1):S90-S102.
  2. Chico A, Vidal-Rios P, Subira M, Novials A. Diabetes Care. 2003;26(4):1153-1157. 
  3. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.
  4. Ahren B. Vasc Health Risk Manag. 2013;9:155-163.