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This is an approved / prescription medicine. Do not use without a prescription and medical supervision.

EMA-approvedaka Tresiba

Insulin degludec β€” Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Insulin degludec (also known as Tresiba) is a peptide catalogued under Hormones & Metabolic (Ultra-long-acting insulin). It is described as: Insulin receptor agonist. Documented context: Diabetes mellitus. Neutral reference entry; EU status: EU-approved prescription medicine.

What is Insulin degludec?

Insulin degludec (brand name Tresiba) is an ultra-long-acting basal insulin analog approved by the FDA (2015) and EMA for type 1 and type 2 diabetes in adults and children.

It has a flat, stable action profile lasting more than 42 hours and is supported by large randomized controlled trials including a dedicated cardiovascular-safety outcome trial.

It is a prescription drug, not a research chemical.

How does Insulin degludec work?

After subcutaneous injection, degludec forms soluble multi-hexamer chains that dissolve slowly and release monomers gradually into the circulation.

This produces an ultra-long, flat and predictable basal insulin action exceeding 42 hours with low day-to-day variability.

What does the research say about Insulin degludec?

  • In the DEVOTE cardiovascular outcomes trial in type 2 diabetes, degludec was non-inferior to insulin glargine U100 for major cardiovascular events and produced significantly less severe hypoglycaemia. [1]
  • In the SWITCH 1 randomized trial in type 1 diabetes, degludec significantly reduced overall symptomatic and nocturnal hypoglycaemia versus glargine U100. [2]
  • In the SWITCH 2 randomized trial in type 2 diabetes, degludec significantly lowered rates of overall and nocturnal symptomatic hypoglycaemia compared with glargine U100. [3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

  • [1] Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes β€” Marso SP et al., The New England Journal of Medicine 2017. (Randomized cardiovascular outcomes trial (DEVOTE))
  • [2] Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial β€” Lane W et al., JAMA 2017. (Randomized crossover trial)
  • [3] Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial β€” Wysham C et al., JAMA 2017. (Randomized crossover trial)
  • [4] Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial β€” Heller S et al., Lancet 2012. (Phase 3 randomized controlled trial)
  • [5] Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial β€” Garber AJ et al., Lancet 2012. (Phase 3 randomized controlled trial)
  • [6] Reduced risk of hypoglycemia with insulin degludec versus insulin glargine in patients with type 2 diabetes requiring high doses of basal insulin: a meta-analysis of 5 randomized begin trials β€” Rodbard HW et al., Endocrine Practice 2014. (Meta-analysis of RCTs)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

In clinical use degludec is injected subcutaneously once daily as the basal insulin, and its long half-life allows some flexibility in injection timing.

This is context only and not dosing guidance; only a prescribing clinician can set an individual's regimen.

Side effects & safety profile

Hypoglycaemia remains the main risk even though degludec lowers nocturnal and severe hypoglycaemia versus glargine; it can still be serious.

Weight gain, injection-site reactions and rare hypersensitivity can also occur, and the U100 and U200 strengths must not be confused.

Dosing must be individualised by a clinician, and degludec should never be interchanged or mixed with other insulins without professional guidance.

Stacking & combinations

As a basal insulin it is commonly combined with a rapid-acting mealtime insulin (basal-bolus therapy) or with oral/non-insulin agents under medical supervision.

Finding Insulin degludec vendors

Finding Insulin degludec vendors

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Frequently asked questions

Yes. It is an FDA- (2015) and EMA-approved prescription basal insulin analog (Tresiba) for type 1 and type 2 diabetes in adults and children. It is not a research-only compound.

References

  1. [1] Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes β€” Marso SP et al., The New England Journal of Medicine 2017. PMID: 28605603. View sourceStudy: Randomized cardiovascular outcomes trial (DEVOTE)Degludec was cardiovascular non-inferior to glargine U100 and caused significantly fewer severe hypoglycaemic episodes.
  2. [2] Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial β€” Lane W et al., JAMA 2017. PMID: 28672316. View sourceStudy: Randomized crossover trialDegludec reduced overall symptomatic and nocturnal hypoglycaemia versus glargine U100 in type 1 diabetes.
  3. [3] Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial β€” Wysham C et al., JAMA 2017. PMID: 28672317. View sourceStudy: Randomized crossover trialDegludec lowered overall and nocturnal symptomatic hypoglycaemia versus glargine U100 in type 2 diabetes.
  4. [4] Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial β€” Heller S et al., Lancet 2012. PMID: 22521071. View sourceStudy: Phase 3 randomized controlled trialDegludec achieved non-inferior HbA1c with lower nocturnal hypoglycaemia versus glargine in type 1 diabetes.
  5. [5] Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial β€” Garber AJ et al., Lancet 2012. PMID: 22521072. View sourceStudy: Phase 3 randomized controlled trialDegludec matched glargine on HbA1c with less nocturnal hypoglycaemia in type 2 diabetes.
  6. [6] Reduced risk of hypoglycemia with insulin degludec versus insulin glargine in patients with type 2 diabetes requiring high doses of basal insulin: a meta-analysis of 5 randomized begin trials β€” Rodbard HW et al., Endocrine Practice 2014. PMID: 24246344. View sourceStudy: Meta-analysis of RCTsPooled BEGIN trials showed lower hypoglycaemia risk with degludec than glargine in high-dose type 2 diabetes.
This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.