Insulin Aspart
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Insulin Aspart: From Diabetes Mellitus to Type 1 Diabetes Mellitus
One-Sentence Summary
Insulin aspart is a rapid-acting insulin analogue originally developed for glycaemic control in diabetes mellitus. The TxGNN model predicts it may be effective for Type 1 Diabetes Mellitus specifically, with 60 clinical trials and 20 publications currently supporting this direction — though this is best read as a confirmatory signal rather than a novel repurposing, since insulin aspart is already an established mealtime insulin for type 1 diabetes in multiple jurisdictions. A blocking data gap on drug label safety information means this candidate cannot yet clear safety pre-screening.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Diabetes Mellitus (rapid-acting mealtime insulin) — precise approved indication text not available in this Evidence Pack |
| Predicted New Indication | Type 1 Diabetes Mellitus |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L1 |
| Germany Market Status | ✗ Not Marketed |
| Number of Authorizations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available (data gap). Based on known clinical information, insulin aspart is a rapid-acting recombinant human insulin analogue engineered for faster onset and shorter duration of action than regular human insulin, making it suitable for mealtime (bolus) glycaemic control.
The predicted indication — type 1 diabetes mellitus — sits within the same core pharmacological use case as insulin aspart's general diabetes indication: exogenous insulin replacement for glucose regulation. In type 1 diabetes specifically, patients are absolutely insulin-deficient due to autoimmune beta-cell destruction, and rapid-acting analogues like aspart are a standard component of basal-bolus and pump-based regimens.
Because this candidate largely reconfirms an already well-established clinical use rather than identifying a mechanistically distant new indication, the "prediction" should be interpreted as validation of TxGNN's ability to recover known drug-disease relationships, rather than a genuine repurposing opportunity. The very large trial and literature base (60 trials, spanning Phase 1–4, including multiple completed Phase 3 RCTs) is consistent with this being a mature, guideline-supported use rather than an exploratory one.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00542399 | Phase 4 | Completed | 50 | Once vs twice-daily detemir with aspart as mealtime insulin in children/adolescents with T1D |
| NCT01697657 | Phase 3 | Completed | 131 | Detemir+aspart vs NPH+aspart: hypoglycaemia frequency in basal-bolus T1D regimen |
| NCT01109316 | Phase 3 | Completed | 132 | CSII pump comparison: insulin lispro vs insulin aspart in T1D |
| NCT00097071 | Phase 3 | Completed | 299 | Safety/efficacy of aspart vs lispro in insulin pumps, children and adolescents with T1D |
| NCT00322257 | Phase 3 | Terminated | 596 | Inhaled mealtime insulin vs subcutaneous aspart (+detemir) in T1D, 104-week RCT |
| NCT03143816 | Phase 4 | Completed | 60 | Prandial insulin aspart vs Technosphere inhaled insulin in T1D on multiple daily injections |
| NCT00593255 | Phase 4 | Completed | 220 | Aspart vs human soluble insulin as mealtime insulin in Chinese T1D/T2D patients |
| NCT03565666 | Phase 2/3 | Completed | 36 | Insulin-only bionic pancreas (aspart-based) closed-loop bridging study |
| NCT02871089 | NA | Active, not recruiting | 96 | Closed-loop insulin delivery from T1D onset on residual beta-cell function |
| NCT05653050 | NA | Completed | 26 | Closed-loop glucose control vs standard pump+CGM in adolescents with T1D |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 41697686 | 2026 | Review | JAMA | Overview of T1D pathophysiology, epidemiology, and complications |
| 37863084 | 2023 | RCT (Phase 3a) | Lancet | ONWARDS 6: once-weekly icodec vs daily degludec, both with aspart bolus, in T1D |
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | EXPECT: degludec vs detemir, both + aspart, in pregnant women with T1D |
| 37804858 | 2023 | RCT | Lancet Diabetes Endocrinol | CopenFast: faster aspart vs aspart on fetal growth in T1D/T2D pregnancy |
| 40129237 | 2025 | RCT (crossover) | Diabetes Obes Metab | Faster aspart vs aspart with non-automated pump + CGM in adults with T1D |
| 37404205 | 2023 | RCT (crossover) | Diabetes Technol Ther | Faster vs standard aspart with hybrid closed-loop in active children/adolescents with T1D |
| 21333580 | 2011 | Systematic Review | Diabetes Metab | Efficacy/safety of aspart vs regular human insulin in T1D and T2D |
| 35746893 | 2023 | Meta-analysis | Diabetes Metab J | FIAsp vs aspart with insulin pump in T1D: pooled efficacy/safety |
| 35933650 | 2022 | Observational | Acta Diabetol | Glulisine vs lispro vs aspart during CSII in T1D: HbA1c, hypo/hyperglycaemia, DKA rates |
| 15871555 | 2003 | Review | Treat Endocrinol | Spotlight review on insulin aspart in T1D and T2D management |
Germany Market Information
Insulin aspart currently has no marketing authorization on record in this jurisdiction (market_status: 未上市, total_licenses: 0). No license entries are available to summarize.
Safety Considerations
Please refer to the package insert for safety information.
(Note: a Blocking data gap — DG001, missing TFDA/regulatory label warnings and contraindications — currently prevents completion of the initial safety screen (S1) for this candidate.)
Conclusion and Next Steps
Decision: Hold
Rationale: Efficacy evidence is strong and mature (L1, multiple completed Phase 3 RCTs plus 60 trials and a broad literature base), but this largely reflects insulin aspart's already-established role in type 1 diabetes rather than a novel repurposing opportunity. More importantly, a Blocking data gap on drug label safety information (warnings/contraindications) means the candidate cannot yet pass initial safety screening (S1), and there is currently no market authorization in this jurisdiction to anchor a regulatory pathway.
To proceed, the following is needed:
- Retrieve and parse official package insert (warnings, contraindications) to close DG001 (Blocking)
- Obtain DrugBank/mechanism-of-action detail to close DG002 (High) and support formal mechanistic rationale
- Confirm actual local regulatory/licensing status, given
market_status: 未上市conflicts with insulin aspart's approval status in most other markets - Clarify with stakeholders whether this candidate should be tracked as "confirmatory validation" rather than a new repurposing opportunity, given original and predicted indications largely overlap
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.