Insulin Aspart

證據等級: L5

預測適應症: 10 個

Insulin Aspart: Established Use in Type 1 Diabetes Mellitus (Data Gap Flagged, Not a Novel Repurposing Candidate)

One-Sentence Summary

Insulin Aspart (DrugBank DB01306) is a rapid-acting human insulin analogue. Because the drug record’s original indication field is empty in this Evidence Pack, the model has surfaced Type 1 Diabetes Mellitus — insulin aspart’s own well-established core indication — as the top “predicted” indication, supported by >50 clinical trials and 20 publications. This is not a genuine drug-repurposing signal; it reflects a data-gap artefact and should be read as a mechanism/evidence confirmation exercise rather than a novel indication proposal.

Quick Overview

Item	Content
Original Indication	Not available in this Evidence Pack (data gap — `original_indications` is empty and no Danish licence text exists to extract from)
Predicted New Indication	Type 1 Diabetes Mellitus (see caveat below — this is the drug’s known established indication, not a novel candidate)
TxGNN Prediction Score	99.95%
Evidence Level	L1 (≥2 completed Phase 3 RCTs identified)
Denmark Market Status	Not Marketed
Number of Marketing Authorisations	0
Recommended Decision	Proceed with Guardrails (for confirmatory/market-entry purposes — see Conclusion)

Why is This Prediction Reasonable?

Detailed mechanism-of-action text is not available in this Evidence Pack (original_moa: [Data Gap]). Based on the information that is available, however, insulin aspart is a rapid-acting human insulin analogue in which proline at position B28 is substituted with aspartic acid, accelerating subcutaneous absorption relative to regular human insulin. Like all insulin products, it acts by binding the insulin receptor and activating the PI3K/Akt and MAPK signalling cascades, promoting cellular glucose uptake, hepatic glycogen synthesis, and suppression of hepatic gluconeogenesis.

Type 1 diabetes mellitus is caused by autoimmune destruction of pancreatic β-cells, resulting in absolute insulin deficiency. Insulin aspart directly replaces this missing hormone — the mechanistic link is direct and well established, not inferential.

Important caveat: The evidence pack’s own repurposing rationale explicitly flags that this is not a repurposing candidate: “此項並非’老藥新用’候選，而是藥物已確立之核心適應症，資料庫因 original_indications 欄位缺失而將其列為預測項目” (this item is not a drug-repurposing candidate but the drug’s already-established core indication; it was listed as a “prediction” only because the original_indications field is empty). The large body of Phase 3 evidence below therefore confirms an already-known use rather than validating a new one. Given that insulin aspart is not currently marketed in Denmark, the practical value of this evidence is to support a potential market authorisation submission, not a repurposing pathway.

For completeness, the model also returned several lower-ranked candidates (autoimmune oophoritis, opsismodysplasia, thiamine-responsive dysfunction syndrome, permanent neonatal diabetes mellitus) with high raw scores but little-to-no direct clinical or mechanistic support in this pack; these are not elaborated further here per the reporting scope, but should not be mistaken for validated repurposing leads.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT01486940	Phase 3	Completed	598	Multinational RCT comparing insulin detemir + insulin aspart vs. NPH + human soluble insulin in basal-bolus regimen for T1DM
NCT01513473	Phase 3	Completed	350	26-week + 26-week extension RCT of degludec vs. detemir with insulin aspart as bolus in children/adolescents with T1DM (BEGIN Young 1)
NCT02670915	Phase 3	Completed	834	Global RCT of faster-acting insulin aspart vs. NovoRapid, both combined with degludec, in children/adolescents with T1DM
NCT01134107	Phase 3	Completed	133	Double-blind crossover RCT of insulin lispro vs. insulin aspart in CSII pump reservoirs for T1DM
NCT00046150	Phase 3	Completed	59	RCT comparing safety of HMR1964 vs. insulin aspart in continuous subcutaneous insulin infusion (CSII) for T1DM
NCT01513590	Phase 3	Completed	394	26-week RCT of insulin degludec/aspart (IDegAsp) vs. BIAsp 30, both with metformin, in insulin-naïve T2DM
NCT04196231	Phase 4	Completed	258	RCT (BEYOND) evaluating durability of glycaemic control with basal insulin/GLP-1RA or SGLT-2i vs. basal-bolus regimen in T2DM
NCT06199505	Phase 2	Completed	153	RCT comparing GZR101 vs. insulin degludec/aspart in T2DM inadequately controlled on oral agents
NCT00675493	N/A (observational)	Completed	942	24-week observational study of NovoMix 30 (biphasic insulin aspart 30) for T1DM/T2DM glycaemic control (Romania)
NCT00700648	N/A (observational)	Completed	3024	Multicentre observational study of IV insulin aspart (NovoRapid) safety/efficacy in hospitalised patients (Asia)

Literature Evidence

PMID	Year	Type	Journal	Key Findings
37863084	2023	RCT	Lancet	ONWARDS 6: once-weekly insulin icodec vs. once-daily degludec as part of basal-bolus regimen (with aspart as bolus) in T1DM
36623517	2023	RCT	Lancet Diabetes & Endocrinology	EXPECT trial: degludec vs. detemir, both combined with insulin aspart, in pregnant women with T1DM
21333580	2011	RCT/Systematic Review	Diabetes & Metabolism	Systematic review confirming efficacy/safety of rapid-acting insulin aspart vs. regular human insulin in T1DM and T2DM
41697686	2026	Review	JAMA	Overview of T1DM pathophysiology (autoimmune β-cell destruction) and epidemiology, underpinning insulin replacement rationale
37290466	2023	Review	Lancet Diabetes & Endocrinology	Management of T1DM in pregnancy, including insulin analogue use and glycaemic targets
15871555	2003	Review	Treatments in Endocrinology	Insulin aspart lowers HbA1c vs. regular human insulin in T1DM/T2DM RCTs
12215068	2002	Review	Drugs	Review of insulin aspart efficacy/safety in T1DM and T2DM management
25143741	2014	Review	Vascular Health and Risk Management	Insulin degludec/aspart combination for T1DM and T2DM treatment
30789066	2019	Review	Expert Opinion on Drug Metabolism & Toxicology	Review of degludec/aspart premix insulin use in T1DM
18710361	2008	Cohort	Expert Opinion on Pharmacotherapy	Evidence-based review of biphasic insulin aspart 30 for T1DM treatment

Denmark Market Information

Insulin Aspart currently has no Marketing Authorisations recorded in Denmark (market status: Not Marketed; 0 licences). No Laegemiddelstyrelsen or centralised EMA authorisation data is available in this Evidence Pack.

Safety Considerations

Please refer to the approved Summary of Product Characteristics (SmPC) for safety information. No key warnings, contraindications, or drug-drug interaction data were available for extraction from this Evidence Pack (DDI query status: not found).

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale:

The clinical trial and literature base for insulin aspart in Type 1 Diabetes Mellitus is extensive and mature (multiple completed Phase 3 RCTs, decades of published evidence), but this evidence confirms an already-established indication, not a novel repurposing opportunity — the “prediction” arose from a data gap in the original_indications field, not a genuine model-driven hypothesis.
Because the product is not currently marketed in Denmark, the practical decision this evidence pack supports is whether to pursue Danish market authorisation for an insulin product with a well-known international safety and efficacy record — not a repurposing evaluation.

To proceed, the following is needed:

TFDA/SmPC-equivalent Danish or EU labelling data (warnings, contraindications, precautions) — currently a Blocking data gap preventing any S1 safety pre-assessment
Confirmed mechanism-of-action documentation from DrugBank (currently a High-severity data gap)
Correction of the original_indications field so future TxGNN runs do not re-surface the drug’s own core indication as a “predicted new indication”
If Danish market entry is the actual goal, a formal review of EMA/centralised authorisation status for insulin aspart products (e.g., NovoRapid, Fiasp) and applicability to the Danish market
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.