Insulin Degludec

The primary activity of insulin, including TRESIBA, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.

• TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis.

• TRESIBA is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients with hypersensitivity to insulin degludec or any of the excipients in TRESIBA [see Warnings and Precautions ( 5.5 )] .contraindicated

• See Full Prescribing Information for important administration instructions ( 2.1 ). • Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen ( 2.1 ). • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis ( 2.1 ). • For pediatric patients requiring less than 5 units of TRESIBA each day, use a TRESIBA U-100 vial ( 2.1 ). • In adults, inject subcutaneously once daily at any time of day ( 2.2 ). • In pediatric patients inject subcutaneously once daily at the same time every day ( 2.2 ). • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.2 ). • The recommended days between dose increases are 3 to 4 days ( 2.2 ). • See Full Prescribing Information for recommended starting dose in insulin naïve patients and patients already on insulin therapy ( 2.3 , 2.4 ). 2.1 Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ( 5.4 ) ] . • Inspect visually for particulate matter and discoloration. Only use TRESIBA if the solution appears clear and colorless. • Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen. • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 , 6.3 )].

• Never share a TRESIBA FlexTouch pen, insulin syringe, or needle between patients, even if the needle is changed ( 5.1 ). • Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring ( 5.2 ). • Hypoglycemia : May be life-threatening. Increase monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness ( 5.3 , 5.4 , 6.1 ). • Hypoglycemia due to medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. DO NOT transfer TRESIBA from the TRESIBA pen into a syringe for administration as overdosage and severe hypoglycemia can result ( 5.4 ). • Hypersensitivity reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TRESIBA, monitor and treat if indicated ( 5.5 ). • Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated ( 5.6 ). • Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs ( 5.7 ).

The following adverse reactions are also discussed elsewhere: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Hypoglycemia due to Medication errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions commonly associated with TRESIBA are: • hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TRESIBA in subjects with type 1 diabetes or type 2 diabetes was evaluated in nine trials of 6-12 month duration in adults and in one trial of 12-month duration in pediatric patients 1 year of age and older with type 1 diabetes. The cardiovascular safety of TRESIBA was evaluated in one double-blinded, event-driven trial of 2-year median duration in patients with type 2 diabetes at high risk of cardiovascular events [see Clinical Studies ( 14 )]. The data in Table 1 reflect the exposure of 1102 adults with type 1 diabetes to TRESIBA with a mean exposure duration to TRESIBA of 34 weeks in three open-label trials; Study A, B and C [see Clinical Studies (14.1)] .

8.1 Pregnancy Risk Summary Available data from one unpublished trial and the published literature with TRESIBA use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In a randomized, parallel-group, open-label actively controlled clinical trial that included 91 pregnant women with type 1 diabetes who were administered TRESIBA once daily and insulin aspart, beginning in gestational weeks 8 to 13 or prior to conception, no clear evidence of maternal or fetal risk associated with TRESIBA use was observed ( see Data ). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy ( see Clinical Considerations ). Rats and rabbits were exposed to insulin degludec in animal reproduction studies during organogenesis. Pre-and post-implantation losses and visceral/skeletal abnormalities were observed in rats at doses 5 times (rat) and at 10 times (rabbit) the human exposure at a dose of 0.75 U/kg/day. These effects were similar to those observed in rats administered human insulin (NPH) (see Data) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Metabolism

Absorption In patients with type 1 diabetes, after 8 days of once daily subcutaneous dosing with 0.4 units/kg of TRESIBA, maximum insulin degludec concentrations of 4472 pmol/L were attained at a median of 9 hours (t max ). After the first dose of TRESIBA, median onset of appearance was around one hour.

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 )] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Lowering the insulin dosage, and adjustment in meal patterns or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with a glucagon for emergency use or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia. Hypokalemia must be corrected appropriately.

• Sep 25, 2015BLABLA203314Novo
• Nov 21, 2016BLABLA208583Novo

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Insulin Degludec, Injection, 10 mL Insulin Degludec vial (NDC 73070-400-11)To be discontinued
  Sponsor: Novo Nordisk, Inc.
  Updated Jul 21, 2025
• Insulin Degludec, Injection, 3 mL Insulin Degludec 100 units/mL (U-100) FlexTouch® (NDC 73070-403-15)To be discontinued
  Sponsor: Novo Nordisk, Inc.
  Updated Jul 21, 2025
• Insulin Degludec, Injection, 3 mL Insulin Degludec 200 units/mL (U-200) FlexTouch® (NDC 73070-503-15)To be discontinued
  Sponsor: Novo Nordisk, Inc.
  Updated Jul 21, 2025

1. 1Blood Glucose Increased3,84816%
2. 2Nausea1,5386.4%
3. 3Blood Glucose Decreased1,3165.5%
4. 4Vomiting1,0224.2%
5. 5Drug Ineffective1,0154.2%
6. 6Diarrhoea1,0054.2%
7. 7Hypoglycaemia9824.1%
8. 8Off Label Use9824.1%
9. 9Fatigue9043.7%
10. 10Dyspnoea8123.4%
11. 11Fall7183.0%
12. 12Dizziness7123.0%
13. 13Constipation6882.9%
14. 14Headache6792.8%
15. 15Glycosylated Haemoglobin Increased6092.5%

The 10 most recently updated of 249 ClinicalTrials.gov registrations naming Insulin Degludec as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)
  Completed · Phase 3 · Interventional · 588 enrolled · Novo Nordisk A/S
  NCT04795531updated 2026-06-12
• A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting
  Completed · Phase 1 · Interventional · 30 enrolled · Novo Nordisk A/S
  NCT06288412updated 2026-06-08
• A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males
  Not yet recruiting · Phase 1 · Interventional · 43 enrolled · The United Bio-Technology (Hengqin) Co., Ltd.
  NCT07630233updated 2026-06-05
• A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
  Recruiting · Phase 2 · Interventional · 100 enrolled · Eli Lilly and Company
  NCT07215312updated 2026-05-22
• Comparing the Safety and Efficacy of Insulin GLARGINE and DEGLUDEC in Glucocorticoid Induced HYPERGLYCEMIA in Hospitalized Patients".
  Completed · Phase 4 · Interventional · 79 enrolled · Max Healthcare Insititute Limited
  NCT07599891updated 2026-05-20
• Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
  Active not recruiting · Observational · 781,430 enrolled · Brigham and Women's Hospital
  NCT05220917updated 2026-05-15
• A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China
  Completed · Phase 3 · Interventional · 414 enrolled · Sunshine Lake Pharma Co., Ltd.
  NCT05802862updated 2026-05-01
• Single-ascending Dose Study of HEC-151 Injection
  Recruiting · Phase 1 · Interventional · 81 enrolled · Sunshine Lake Pharma Co., Ltd.
  NCT07376200updated 2026-04-29
• A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes
  Recruiting · Phase 1 · Interventional · 55 enrolled · Jiangsu HengRui Medicine Co., Ltd.
  NCT07032688updated 2026-04-17
• Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes
  Not yet recruiting · Phase 2 · Interventional · 345 enrolled · Gan & Lee Pharmaceuticals.
  NCT07387003updated 2026-04-15

Frequently asked questions

How does Insulin Degludec work?

The primary activity of insulin, including TRESIBA, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.

What is Insulin Degludec used for?

According to FDA labeling, Insulin Degludec carries indications including: TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Insulin Degludec?

Insulin Degludec is classified as Insulins and analogues for injection, long-acting, Insulin Analog, Insulin Receptor Agonists, Decreased Glycogenolysis, Decreased Lipolysis, Increased Glucose Transport into Cells, Increased Glycogenesis, Increased Lipogenesis, Increased Protein Synthesis.

What are the brand names for Insulin Degludec?

Insulin Degludec is marketed under brand names including Tresiba, Xultophy.

What are the contraindications for Insulin Degludec?

Insulin Degludec labeling lists contraindications including: TRESIBA is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients with hypersensitivity to insulin degludec or any of the excipients in TRESIBA [see Warnings and Precautions ( 5.5 )] .. Always consult the full prescribing information and a clinician.