Insulin Icodec

The primary activity of insulin, including Awiqli, 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.

• Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.ICD-10: E11.9

• Awiqli is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.2 )] . • In patients with hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli FlexTouch.contraindicated

• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goals. ( 2.1 ) • See Full Prescribing Information for important administration instructions ( 2.2 ) • Inject Awiqli subcutaneously into the thigh, upper arm, or abdomen. ( 2.2 ) • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) • See Full Prescribing Information for the recommended starting dosage in insulin naïve patients ( 2.3 ) and recommendations for switching patients from daily basal insulin. ( 2.4 ) • Closely monitor glucose when switching to Awiqli. ( 2.4 ) 2.1 General Dosing Instructions Awiqli FlexTouch is available as a single-patient-use FlexTouch pen. • Inject Awiqli subcutaneously once-weekly on any day of the week on the same day each week. • The Awiqli FlexTouch pen delivers doses in 10 unit increments and can deliver up to 700 units in a single injection. • Individualize and titrate the dose of Awiqli based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • The potency of insulin analogues, including insulin icodec-abae is expressed in units. One (1) unit of insulin icodec-abae corresponds to 1 international unit of human insulin. • Dose adjustments may be needed with changes in renal or hepatic function or during illness to minimize the risk of hypoglycemia or hyperglycemia.

• Hypoglycemia Due to Medication Errors and Accidental Overdose : Accidental mix-ups between insulin products can occur. Advise patients to always check the product label before each injection to confirm they are using Awiqli and not another insulin or injectable antidiabetic medicine. DO NOT transfer Awiqli from the Awiqli FlexTouch pen into a syringe for administration as overdosage and severe hypoglycemia can result. ( 5.1 ) • Hypoglycemia : May be life-threatening. Increase monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity, and in patients with renal impairment, hepatic impairment or hypoglycemia unawareness. ( 5.2 ) • 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. ( 5.3 ) • Hypersensitivity Reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Awiqli FlexTouch, monitor and treat if indicated. ( 5.4 ) • Hypokalemia : May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated. ( 5.5 ) • Never share an Awiqli FlexTouch pen between patients, even if the needle is changed.

The following adverse reactions are also discussed elsewhere: • Hypoglycemia Due to Medication Errors and Accidental Overdose [see Warnings and Precautions ( 5.1 )] • Hypoglycemia [see Warnings and Precautions ( 5.2 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] • Hypokalemia [see Warnings and Precautions ( 5.5 )] Adverse reactions commonly associated with Awiqli are: • hypoglycemia, hypersensitivity reactions (e.g., urticaria, swelling face and lips), injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-844-668-6463 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 Awiqli in patients with type 2 diabetes was evaluated in five clinical trials involving 1,880 adults with type 2 diabetes exposed to Awiqli, with a mean exposure duration of 26 to 52 weeks across the five trials [see Clinical Studies ( 14 )] . The type 2 diabetes population had the following characteristics: mean age was 59 years and 5% were older than 75 years, 59% were male, 71% were White, 3.6% were Black or African American, and 13% were Hispanic or Latino ethnicity. The mean BMI was 30.7 kg/m 2 . The mean duration of diabetes was 13 years and the mean HbA 1c at baseline was 8.6%.

8.1 Pregnancy Risk Summary There are no available data with Awiqli in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. 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 icodec-abae in animal reproduction studies during organogenesis. No adverse developmental effects were observed in rats or rabbits at exposures approximately equal to human exposure at a dose of 230 U/week [see Data] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20-25% in women with an HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.

Metabolism

Absorption Dose proportionality in total exposure is observed after subcutaneous administration of Awiqli within the therapeutic dose range. Insulin icodec-abae concentration reached steady state levels after 2 to 3 weeks of Awiqli administration with a one-time 50% additional dose for the first dose [see Dosage and Administration ( 2.4 )] and after 3 to 4 weeks when initiating Awiqli without a one-time additional dose [see Dosage and Administration ( 2.4 )] .

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 ( 5.2 , 5.5 )] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Lowering the dosage of Awiqli, adjustments in meal patterns, or physical activity may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with a glucagon product 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. Overdosing has been investigated in a clinical pharmacology trial [see Clinical Pharmacology ( 12.2 )] .

1. 1Glycosylated Haemoglobin Increased250%
2. 2Angiosarcoma125%
3. 3Atrial Fibrillation125%
4. 4Blood Albumin Increased125%
5. 5Cataract125%
6. 6Coronary Artery Disease125%
7. 7Diabetic Neuropathy125%
8. 8Diabetic Retinopathy125%
9. 9Erectile Dysfunction125%
10. 10Gastric Varices125%
11. 11Hepatic Cirrhosis125%
12. 12Hepatitis125%
13. 13Infusion Related Reaction125%
14. 14Left Ventricular Dysfunction125%
15. 15Macular Degeneration125%

The 10 most recently updated of 37 ClinicalTrials.gov registrations naming Insulin Icodec as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)
  Completed · Phase 3 · Interventional · 683 enrolled · Novo Nordisk A/S
  NCT05259033updated 2026-06-12
• 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 Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec
  Not yet recruiting · Observational · 214 enrolled · Novo Nordisk A/S
  NCT07632404updated 2026-06-08
• General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus
  Recruiting · Observational · 630 enrolled · Novo Nordisk A/S
  NCT06807190updated 2026-06-05
• A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes
  Recruiting · Phase 4 · Interventional · 586 enrolled · Novo Nordisk A/S
  NCT07112339updated 2026-06-05
• A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar
  Active not recruiting · Observational · 245 enrolled · Novo Nordisk A/S
  NCT07160816updated 2026-06-05
• A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)
  Completed · Phase 3 · Interventional · 485 enrolled · Novo Nordisk A/S
  NCT06269107updated 2026-06-05
• A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
  Recruiting · Phase 3 · Interventional · 877 enrolled · Novo Nordisk A/S
  NCT07076199updated 2026-06-05
• A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
  Completed · Phase 3 · Interventional · 148 enrolled · Novo Nordisk A/S
  NCT05813912updated 2026-06-03

Frequently asked questions

How does Insulin Icodec work?

The primary activity of insulin, including Awiqli, 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 Icodec used for?

According to FDA labeling, Insulin Icodec carries indications including: Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Insulin Icodec?

Insulin Icodec is classified as Insulins and analogues for injection, long-acting.

What are the brand names for Insulin Icodec?

Insulin Icodec is marketed under brand names including Awiqli.

What are the contraindications for Insulin Icodec?

Insulin Icodec labeling lists contraindications including: Awiqli is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.2 )] . • In patients with hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli FlexTouch.. Always consult the full prescribing information and a clinician.