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 (DrugBank DB01306) is a rapid-acting insulin analog used for glycemic control in diabetes mellitus. The TxGNN model predicts it may be effective for Type 1 Diabetes Mellitus, supported by 10+ clinical trials and 20 publications currently on record. Note: the evidence pack itself flags this as likely not a true “old drug, new use” case — type 1 diabetes is almost certainly already a standard approved indication for insulin aspart; the original_indications field is empty due to a data gap (DG002), so this should be confirmed against the actual product label rather than treated as a novel repurposing signal.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in evidence pack (data gap, DG002) — literature evidence indicates insulin aspart is a rapid-acting insulin analog already used for glycemic control in type 1 and type 2 diabetes mellitus |
| Predicted New Indication | Type 1 Diabetes Mellitus |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L1 |
| Taiwan (TFDA) Market Status | 未上市 (Not Marketed) |
| Number of TFDA Licenses | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available (DG002, High severity data gap). Based on known information, insulin aspart is a rapid-acting insulin analog; its efficacy in glycemic control for diabetes mellitus has been proven, and mechanistically it directly binds the insulin receptor to promote peripheral glucose utilization.
Type 1 diabetes mellitus is a disease of absolute insulin deficiency due to autoimmune β-cell destruction. Physiologic insulin replacement — including rapid-acting analogs like aspart used as prandial/bolus insulin in basal-bolus regimens — is the established standard of care for this condition. The mechanistic link is therefore direct and non-speculative, not an indirect or exploratory repurposing hypothesis.
However, this reframes the nature of the “prediction”: since original_indications is empty in this evidence pack, it is unclear whether type 1 diabetes is already an approved indication for this product elsewhere. Given that virtually all commercial insulin aspart products (e.g., NovoRapid/NovoLog) are already indicated for type 1 diabetes, this candidate likely represents a data-completeness gap rather than a genuine new-indication opportunity, and should be verified against the actual product label before being treated as a repurposing case.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01992588 | Phase 1 | Completed | 48 | PK/PD comparison of FIAsp (faster-acting insulin aspart) vs. insulin aspart as CSII bolus in T1DM |
| NCT01697657 | Phase 3 | Completed | 131 | Multinational crossover RCT: insulin detemir+aspart vs. NPH+aspart on hypoglycemia frequency in T1DM basal-bolus regimen |
| NCT03143816 | Phase 4 | Completed | 60 | Real-life pilot comparing prandial insulin aspart vs. Technosphere inhaled insulin in T1DM |
| NCT00542399 | Phase 4 | Completed | 50 | Once- vs. twice-daily insulin detemir with Novorapid (aspart) as mealtime insulin in pediatric T1DM |
| NCT01774565 | NA | Completed | 43 | Closed-loop glucose control comparing faster insulin aspart vs. standard insulin aspart |
| NCT07068295 | Phase 1 | Completed | 65 | PK/PD/safety of a novel fast-acting insulin vs. insulin aspart via insulin pump |
| NCT01194258 | Phase 2 | Completed | 132 | Double-blind crossover: Lispro-PH20/Aspart-PH20 vs. insulin lispro for prandial control |
| NCT05653050 | NA | Completed | 26 | Closed-loop glucose control with ultra-rapid insulin vs. standard pump therapy in adolescents with T1DM |
| NCT03959514 | Phase 1 | Completed | 18 | Glucose clamp PK/PD/safety comparison of AT247 vs. NovoRapid® vs. Fiasp® in T1DM |
| NCT00097071 | Phase 3 | Completed | 299 | Safety and efficacy of insulin aspart (NovoLog®) vs. insulin lispro via CSII in children/adolescents with T1DM |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37863084 | 2023 | RCT (Phase 3a) | Lancet | ONWARDS 6: once-weekly insulin icodec vs. once-daily degludec, both as part of a basal-bolus (aspart) regimen, in T1DM |
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | EXPECT trial: degludec vs. detemir, both combined with insulin aspart, in pregnant women with T1DM |
| 21333580 | 2011 | RCT/Systematic Review | Diabetes & Metabolism | Efficacy and safety of rapid-acting insulin aspart vs. regular human insulin in T1DM/T2DM |
| 18710361 | 2008 | RCT | Expert Opin Pharmacother | Biphasic insulin aspart 30 for treatment of type 1 diabetes mellitus |
| 40129237 | 2025 | RCT (crossover) | Diabetes Obes Metab | Faster-acting insulin aspart vs. insulin aspart in T1DM with non-automated pump + CGM |
| 37804858 | 2023 | RCT | Lancet Diabetes Endocrinol | CopenFast: faster aspart vs. insulin aspart in T1DM/T2DM during pregnancy and post-delivery |
| 37404205 | 2023 | RCT (double-blind crossover) | Diabetes Technol Ther | Faster vs. standard insulin aspart with hybrid automated insulin delivery in youth with T1DM |
| 41697686 | 2026 | Review | JAMA | Type 1 Diabetes: A Review — disease overview and insulin-based management |
| 15871555 | 2003 | Review | Treatments in Endocrinology | Spotlight on insulin aspart in type 1 and 2 diabetes mellitus |
| 12215068 | 2002 | Review | Drugs | Insulin aspart: a review of its use in the management of type 1 and 2 diabetes mellitus |
Safety Considerations
Please refer to the package insert for safety information. (No key warnings, contraindications, or DDI data are currently on record for this candidate — TFDA label data is a Blocking data gap, DG001.)
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Clinical and literature evidence for insulin aspart in type 1 diabetes is extensive and meets L1 evidence criteria (multiple completed Phase 3 RCTs, e.g., NCT01697657, NCT00097071). However, the product is not currently marketed in Taiwan (0 TFDA licenses), TFDA label safety data is a Blocking gap (DG001), and MOA/original-indication data are missing (DG002) — so this cannot be treated as a confirmed novel repurposing case without further verification.
To proceed, the following is needed:
- TFDA-approved package insert (warnings, contraindications, DDI) — Blocking gap, must resolve before any safety review (DG001)
- DrugBank-sourced MOA confirmation (DG002)
- Confirmation of the drug’s actual approved original indication(s), to determine whether “Type 1 Diabetes Mellitus” is a genuine new indication or already standard labeling elsewhere
- Regulatory pathway assessment for Taiwan market entry (currently 未上市, 0 licenses)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.