Insulin Aspart
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
- Insulin Aspart
- Insulin Aspart: Type 1 Diabetes Mellitus — Existing Indication, Not a New Repurposing Signal
Insulin Aspart: Type 1 Diabetes Mellitus — Existing Indication, Not a New Repurposing Signal
One-Sentence Summary
Insulin aspart (DrugBank ID DB01306) is a rapid-acting insulin analog; this evidence pack has no record of its original indication or MOA (data gap). TxGNN's top-ranked prediction, Type 1 Diabetes Mellitus, is supported by 50 clinical trials and 20 publications — but this volume of evidence reflects insulin aspart's already-established standard-of-care role in T1DM, not a genuine new-use discovery.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not provided in evidence pack (original_indications is empty) |
| Predicted New Indication | Type 1 Diabetes Mellitus |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L1 |
| Finland Market Status | Not Marketed |
| Number of Authorizations | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in this evidence pack. Based on known pharmacological classification, insulin aspart is a rapid-acting recombinant human insulin analog, engineered for faster subcutaneous absorption than regular human insulin; its role is direct replacement of endogenous insulin to control blood glucose.
Critically, the evidence pack's own analysis flags an important caveat: Type 1 Diabetes Mellitus is not really a novel predicted indication for insulin aspart — it is the drug's actual, long-standing, guideline-standard indication. The fact that original_indications is empty and market_status shows "Not Marketed" in Finland appears to reflect gaps in the underlying regulatory database rather than clinical reality, since insulin aspart products (e.g., NovoRapid/NovoLog, Fiasp) are widely used for T1DM glycemic control internationally.
Mechanistically, T1DM is caused by autoimmune destruction of pancreatic beta cells and absolute insulin deficiency — exogenous rapid-acting insulin is the definitive replacement therapy. This is why the model surfaces such a high score and a large body of directly relevant trials and literature: TxGNN has essentially rediscovered an existing, proven treatment relationship rather than identifying a new therapeutic hypothesis.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00322257 | Phase 3 | Terminated | 596 | Direct comparison of inhaled mealtime insulin vs. subcutaneous insulin aspart (+ insulin detemir) in T1DM over 104 weeks |
| NCT02546401 | Phase 3 | Completed | 22 | Tested pre- vs. post-meal bolus timing of insulin aspart via insulin pump in T1DM patients |
| NCT05413369 | Phase 3 | Completed | 582 | Large multicenter trial comparing iGlarLixi to IDegAsp (insulin degludec/aspart) in diabetes inadequately controlled on oral agents |
| NCT02518945 | Phase 3 | Completed | 26 | Dapagliflozin add-on to liraglutide and insulin in T1DM; insulin (incl. aspart) as background therapy |
| NCT03800875 | Phase 2 | Completed | 24 | Dual-hormone (insulin-pramlintide) closed-loop delivery without carbohydrate counting in T1DM adults |
| NCT00046150 | Phase 3 | Completed | 59 | Safety comparison of HMR1964 vs. insulin aspart via continuous subcutaneous insulin infusion in T1DM |
| NCT01513590 | Phase 3 | Completed | 394 | 26-week trial comparing insulin degludec/aspart (IDegAsp) vs. biphasic insulin aspart 30, both with metformin |
| NCT00312156 | Phase 3 | Completed | 347 | Insulin detemir vs. NPH insulin, both combined with mealtime insulin aspart, in children/adolescents with T1DM |
| NCT00474045 | Phase 3 | Completed | 470 | Insulin detemir vs. NPH insulin combined with insulin aspart bolus in pregnant women with T1DM |
| NCT00082407 | Phase 3 | Completed | 505 | Exenatide vs. twice-daily biphasic insulin aspart in diabetes on sulfonylurea/metformin |
40 additional trials were returned but are not shown; most involve insulin aspart as background/comparator therapy in device or combination studies.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21333580 | 2011 | RCT (systematic review-based) | Diabetes & Metabolism | Efficacy/safety comparison of rapid-acting insulin aspart vs. regular human insulin in T1DM/T2DM |
| 37863084 | 2023 | RCT (Phase 3a) | Lancet | ONWARDS 6: once-weekly insulin icodec vs. once-daily degludec in basal-bolus regimen for T1DM |
| 36623517 | 2023 | RCT | Lancet Diabetes & Endocrinology | EXPECT trial: insulin degludec vs. detemir, both with insulin aspart, in pregnant women with T1DM |
| 37290466 | 2023 | Review | Lancet Diabetes & Endocrinology | Management of T1DM in pregnancy — lifestyle, pharmacological treatment, glycaemic targets |
| 41697686 | 2026 | Review | JAMA | Type 1 Diabetes overview — autoimmune beta-cell destruction, epidemiology, complications |
| 15871555 | 2003 | Review | Treatments in Endocrinology | Spotlight on insulin aspart in T1DM/T2DM — lower HbA1c and improved postprandial control vs. regular insulin |
| 12215068 | 2002 | Review | Drugs | Insulin aspart review of use in T1DM/T2DM management |
| 18710361 | 2008 | Review | Expert Opinion on Pharmacotherapy | Biphasic insulin aspart 30 for treatment of T1DM |
| 35746893 | 2023 | Meta-analysis | Diabetes & Metabolism Journal | Fast-acting aspart vs. aspart via insulin pump in T1DM |
| 31345519 | 2019 | Review | Endocrinology and Metabolism Clinics of North America | Type 1 diabetes in pregnancy — glycemic control challenges and technology advances |
10 additional publications were returned but are not shown.
Finland Market Information
Insulin aspart currently shows no marketing authorization records in this evidence pack (market_status: Not Marketed, total_licenses: 0). Given insulin aspart's broad clinical use and trial base shown above, this likely reflects a gap in the underlying regulatory database rather than actual market absence, and should be re-verified against Fimea's official registry.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale:
- The scale of Phase 3 trial and literature evidence (L1) confirms insulin aspart's efficacy for T1DM, but this is because T1DM is already its standard indication — not a genuine repurposing discovery. This candidate should be handled as a data-quality correction, not a novel opportunity, before any downstream action is taken.
- Separately, two other TxGNN signals for this drug (drug-induced localized lipodystrophy, centrifugal lipodystrophy) appear to have reversed causality — insulin injection is a known cause of localized lipodystrophy, not a treatment for it — and should be flagged as safety review items rather than repurposing candidates.
To proceed, the following is needed:
- TFDA/Fimea package insert (warnings and contraindications) — currently a blocking data gap (DG001)
- DrugBank-sourced mechanism of action confirmation (DG002)
- Correction of
original_indicationsandmarket_statusfields in the source database to reflect insulin aspart's actual approved indication and Finland marketing status - Re-classification of this candidate in the pipeline from "predicted new indication" to "existing indication — database gap"
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.