Measures should be taken to lower the risk of hypoglycemia in older adults

"Hypoglycemia should be avoided in older adults with diabetes. It should be assessed and managed by adjusting glycemic targets and pharmacologic interventions."2  –American Diabetes Association. Standards of Medical Care in Diabetes—2018.

Common risk factors for hypoglycemia

- Diabetes treatment (both secretagogues and insulin)1
- Older age2
- Long duration of diabetes3
- Impaired awareness of hypoglycemia1
- Certain drugs that may mask the signs and symptoms of hypoglycemia, including beta blockers, clonidine, guanethidine, and reserpine1
- Impaired renal function1
- Hepatic dysfunction1
- Increased exercise (relative to usual)1
- Irregular meal habits1
- Alcohol consumption3
- Inaccurate blood glucose monitoring4

  • Diabetes treatment (both secretagogues and insulin)1
  • Older age2
  • Long duration of diabetes3
  • Impaired awareness of hypoglycemia1
  • Certain drugs that may mask the signs and symptoms of hypoglycemia, including beta blockers, clonidine, guanethidine, and reserpine1
  • Impaired renal function1
  • Hepatic dysfunction1
  • Increased exercise (relative to usual)1
  • Irregular meal habits1
  • Alcohol consumption3
  • Inaccurate blood glucose monitoring4
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Hypoglycemia may be happening more often than you think


Many patients with hypoglycemic events are asymptomatic5

Type 2 diabetes

Type 2 diabetes patients with unrecognized hypoglycemia statistic

In a study of patients with type 2 diabetes (n=30), 47% had unrecognized hypoglycemia as measured by CGMS5

Type 1 diabetes

Type 1 diabetes patients with unrecognized hypoglycemia statistic

In a study of patients with type 1 diabetes (n=40), 63% had unrecognized hypoglycemia as measured by CGMS5

After experiencing hypoglycemia, patients often:

  • Modify their insulin dose6
  • Avoid physical exercise7
  • Skip an insulin dose6
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Study design
Chico et al study5

Population: 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 MACEa and rate of severe hypoglycemiab

See DEVOTE data

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

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
  • 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.

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
  • 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, 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 2018.
  2. Cefalu WT. Diabetes Care. 2018;41(suppl 1):S119-S125. https://doi.org/10.2337/dc18-S011.
  3. Ahren B. Vasc Health Risk Manag. 2013;9:155-163.
  4. Cefalu WT. Diabetes Care. 2018;41(suppl 1):S55-S64. https://doi.org/10.2337/dc18-S006.
  5. Chico A, Vidal-Rios P, Subira M, Novials A. Diabetes Care. 2003;26(4):1153-1157.
  6. Leiter LA, Boras D, Woo VC. Can J Diabetes. 2014;38(1):38-44.
  7. Younk LM, Mikeladze M, Tate D, Davis SN. Expert Rev Endocrinol Metab. 2011;6(1):93-108.