Insulin Degludec
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
Insulin Degludec: Autoimmune oophoritis
One-Sentence Summary
Insulin degludec is an ultra-long-acting basal insulin analogue, originally used to treat diabetes mellitus and diabetic ketoacidosis. The TxGNN model predicts it may be effective for autoimmune oophoritis, with 40 clinical trials and 19 publications currently supporting this direction. Note that type 1 diabetes falls within the drug’s existing diabetes indication, so this prediction mainly confirms known use rather than opening a truly new therapeutic area.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Autoimmune oophoritis |
| TxGNN Prediction Score | 0.9923 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 3 of 4; cancelled: 1) |
| Number of DINs | 4 (marketed: 3) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, insulin degludec is a basal insulin analogue that binds the insulin receptor and replaces the insulin that people with type 1 diabetes can no longer produce. Published reviews describe it as having a long half-life (about 25 hours) and a duration of action beyond 42 hours, giving a flat and stable glucose-lowering profile.
Type 1 diabetes is a form of diabetes mellitus, so the prediction lines up with the drug’s established use. The high TxGNN score is consistent with this. It should be read as confirmation of an existing indication, not as true repurposing.
Five other predicted conditions (autoimmune oophoritis, opsismodysplasia, thiamine-responsive dysfunction syndrome, focal stiff limb syndrome, classic stiff person syndrome) have no clinical trials or literature. They rest on computational prediction alone, and several are likely driven by comorbid diabetes rather than a true treatment effect. They are not recommended for further evaluation at this point (Hold).
Clinical Trial Evidence
Forty trials are linked to this prediction. The table lists the most relevant ones, prioritising direct degludec studies and completed Phase 3 trials.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02034513 | Phase 3 | Completed | 501 | SWITCH 1: double-blind crossover comparing the safety and efficacy of degludec vs glargine, both with insulin aspart, in type 1 diabetes |
| NCT02500706 | Phase 3 | Completed | 1108 | Faster-acting insulin aspart vs NovoRapid, both with degludec, in adults with type 1 diabetes |
| NCT02670915 | Phase 3 | Completed | 834 | Faster-acting insulin aspart vs NovoRapid, both with degludec, in children and adolescents with type 1 diabetes |
| NCT05463744 | Phase 3 | Completed | 692 | Weekly basal insulin efsitora alfa compared with degludec in type 1 diabetes on multiple daily injections |
| NCT00978627 | Phase 3 | Completed | 548 | BOOST T1: degludec/aspart (IDegAsp) once daily plus aspart vs detemir plus aspart in type 1 diabetes |
| NCT01835431 | Phase 3 | Completed | 362 | IDegAsp once daily plus aspart vs detemir plus aspart in children and adolescents with type 1 diabetes |
| NCT01569841 | Phase 3 | Completed | 24 | Degludec vs glargine on glycaemic control using continuous glucose monitoring in type 1 diabetes |
| NCT04075513 | Phase 4 | Completed | 343 | 12-week comparison of Toujeo and Tresiba (degludec) on time in range and variability by continuous glucose monitoring |
| NCT03838783 | Phase 4 | Unknown | 30 | Degludec with insulin pump therapy in avidly exercising people with type 1 diabetes |
| NCT00612040 | Phase 2 | Completed | 178 | Two degludec formulations vs glargine, all with insulin aspart, in a 16-week basal/bolus regimen in type 1 diabetes |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | EXPECT: degludec vs detemir, both with aspart, in pregnant women with type 1 diabetes (non-inferiority) |
| 39270686 | 2024 | RCT | Lancet | QWINT-5: once-weekly efsitora vs once-daily degludec in adults with type 1 diabetes |
| 37863084 | 2023 | RCT | Lancet | ONWARDS 6: once-weekly icodec vs once-daily degludec in type 1 diabetes |
| 36763996 | 2022 | Meta-analysis | Clin Ther | Efficacy and tolerability of degludec vs other long-acting basal analogues in type 1 and type 2 diabetes |
| 33662147 | 2021 | Systematic review | Cochrane Database Syst Rev | (Ultra-)long-acting insulin analogues for people with type 1 diabetes |
| 29477399 | 2018 | Network meta-analysis | Value Health | Relative efficacy and safety of basal insulin regimens in adults with type 1 diabetes |
| 40903851 | 2025 | Randomised trial (classified as cohort) | Diabetes Obes Metab | Early degludec added to intravenous insulin infusion vs infusion alone in diabetic ketoacidosis |
| 35147781 | 2022 | Real-world study | Acta Diabetol | Pregnancy outcomes in women with type 1 diabetes using degludec vs other long-acting analogues |
| 25963320 | 2015 | Review | Diabetes Res Clin Pract | Clinical use of degludec: long half-life, flat profile, lower hypoglycaemia concerns |
| 23620200 | 2013 | Review | Drugs | Review of degludec and degludec/aspart in diabetes management |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02467887 | TRESIBA | Not listed | Not listed |
| 02467879 | TRESIBA | Not listed | Not listed |
| 02467860 | TRESIBA | Not listed | Not listed |
| 02474875 | XULTOPHY | Not listed | Not listed |
Safety Considerations
- Drug Interactions: The interaction screen returned 100 interacting drugs, mostly of Moderate or Minor severity. Examples of moderate interactions:
- Glucose-lowering agents (metformin, pioglitazone, alogliptin, albiglutide), which may add to the glucose-lowering effect
- Sympathomimetics and bronchodilators (epinephrine, phenylephrine, pseudoephedrine, salbutamol, formoterol)
- Beta-blockers (acebutolol)
- Hormones and corticosteroids (hydrocortisone, estradiol, levonorgestrel, norethisterone)
- Others (hydrochlorothiazide, doxycycline, ethanol, alpelisib)
- Topical corticosteroids (hydrocortisone topical, alclometasone topical) were rated Minor.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Several completed Phase 3 trials, plus randomised trials, meta-analyses and a Cochrane review, support degludec in type 1 diabetes. This is an extension of an existing indication and not a new use. Package insert safety data and mechanism data are still missing.
To proceed, the following is needed:
- Health Canada package insert warnings and contraindications (a blocking gap for safety screening)
- Approved indication text, dosage forms and manufacturers for the four Canadian DINs
- Mechanism of action data from DrugBank
- A safety monitoring plan, especially for hypoglycaemia, and attention to the interacting drugs listed above
- For the five other predicted conditions: no action unless supporting clinical or mechanistic evidence emerges
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.