Insulin Aspart

證據等級: L5

預測適應症: 10 個

Insulin Aspart: From Diabetes Mellitus (Original Indication Unconfirmed) to Type 1 Diabetes Mellitus

One-Sentence Summary

Insulin aspart is a rapid-acting recombinant insulin analogue; the evidence pack does not contain a confirmed original-indication text (Blocking Data Gap DG001), though insulin analogues of this class are used generally for diabetes mellitus glycemic control. The TxGNN model's top prediction is Type 1 Diabetes Mellitus, supported by 10+ clinical trials and 20 publications. Importantly, the model's own rationale flags this as not genuine repurposing — insulin aspart is already a standard-of-care therapy for Type 1 Diabetes; the "prediction" reconfirms an existing pharmacological use rather than proposing a novel indication.

Quick Overview

Item	Content
Original Indication	Not documented in this evidence pack (Blocking Data Gap DG001 — TFDA/NZ package insert not yet retrieved)
Predicted New Indication	Type 1 Diabetes Mellitus
TxGNN Prediction Score	99.95%
Evidence Level	L1
New Zealand 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 (Data Gap DG002). Based on known pharmacology, insulin aspart is a rapid-acting human insulin analogue (class: insulin analogues) that mimics endogenous prandial insulin secretion by binding the insulin receptor to promote peripheral glucose uptake and suppress hepatic glucose output.

Type 1 diabetes mellitus is characterized by absolute insulin deficiency from autoimmune beta-cell destruction, and exogenous insulin replacement — including rapid-acting analogues like insulin aspart — is the established standard of care. Mechanistically, this makes the model's prediction directly applicable.

However, this candidate should be interpreted differently from a typical repurposing case. Per the evidence pack's own repurposing rationale, insulin aspart's applicability to Type 1 Diabetes is not a "new" therapeutic hypothesis but reflects its existing, well-established clinical use; the empty original_indications field in this dataset is a data-collection gap, not a clinical fact indicating the drug lacks an approved diabetes indication. This candidate is best read as a validation signal for the TxGNN model rather than a novel repurposing opportunity.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT01682902	Phase 1	Completed	43	Continuous subcutaneous infusion comparison of NN1218 formulations vs. NovoLog® (insulin aspart) in Type 1 diabetes
NCT00322257	Phase 3	Terminated	596	Inhaled mealtime insulin vs. subcutaneous insulin aspart (both with insulin detemir) in Type 1 diabetes; efficacy and pulmonary safety comparison
NCT02546401	Phase 3	Completed	22	Pre-meal vs. post-meal insulin aspart bolus timing in Type 1 diabetic patients on insulin pumps
NCT01464099	Phase 1	Completed	24	Bioequivalence of NovoLog® 100 U/mL vs. 200 U/mL formulations via CSII + mealtime bolus in Type 1 diabetes
NCT00992537	Phase 1	Completed	27	PK/PD comparison of NN5401 (insulin degludec/aspart) vs. NN1250 (degludec) vs. insulin aspart in Type 1 diabetes
NCT05413369	Phase 3	Completed	582	iGlarLixi vs. IDegAsp (insulin degludec/aspart) in Chinese Type 2 diabetes inadequately controlled on oral agents
NCT02518945	Phase 3	Completed	26	Dapagliflozin added to liraglutide + insulin in Type 1 diabetes; insulin used as background therapy
NCT03660553	Phase 4	Terminated	7	Simplified basal-only insulin regimen vs. basal-bolus in elderly patients; small sample, terminated early
NCT03800875	Phase 2	Completed	24	Dual-hormone (insulin-pramlintide) closed-loop delivery without carbohydrate counting in Type 1 diabetes
NCT00748137	N/A	Unknown	150	Bolus insulin dose-calculator card vs. fixed carbohydrate exchange in pediatric Type 1 diabetes

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) in Type 1 diabetes
36623517	2023	RCT	Lancet Diabetes Endocrinol	EXPECT trial: insulin degludec vs. detemir, both combined with insulin aspart, in pregnant women with Type 1 diabetes
21333580	2011	RCT (systematic review)	Diabetes Metab	Systematic review comparing insulin aspart with regular human insulin in Type 1/Type 2 diabetes
41697686	2026	Review	JAMA	General review of Type 1 diabetes pathophysiology, epidemiology, and complications
37290466	2023	Review	Lancet Diabetes Endocrinol	Management of Type 1 diabetes in pregnancy, including insulin technology updates
15871555	2003	Review	Treatments in Endocrinology	Spotlight review on insulin aspart efficacy in Type 1 and Type 2 diabetes
12215068	2002	Review	Drugs	Insulin aspart review: rapid absorption and glycemic control vs. regular human insulin
31345519	2019	Review	Endocrinol Metab Clin North Am	Type 1 diabetes in pregnancy, insulin management strategies
25143741	2014	Review	Vasc Health Risk Manag	Insulin degludec/aspart combination for Type 1 and Type 2 diabetes treatment
18710361	2008	Review	Expert Opin Pharmacother	Biphasic insulin aspart 30 for treatment of Type 1 diabetes mellitus

New Zealand Market Information

No authorizations are on file for insulin aspart in this evidence pack — taiwan_regulatory.market_status is "Not Marketed" and total_licenses is 0. This is consistent with Blocking Data Gap DG001 (TFDA/NZ package insert not yet retrieved) and should be verified directly against the regulator's product register before any market-facing claims are made.

Safety Considerations

Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Ten clinical trials and ten publications, including multiple completed Phase 3 RCTs, support insulin aspart's role in Type 1 diabetes management, giving this candidate the strongest evidence level (L1) in the dataset. However, the evidence pack's own rationale indicates this is not a genuine repurposing signal but a reconfirmation of insulin aspart's existing, standard-of-care use in Type 1 diabetes — and a Blocking safety data gap (DG001) and zero New Zealand market authorizations mean the candidate cannot proceed past initial safety review as-is.

To proceed, the following is needed:

TFDA/NZ package insert (warnings, contraindications) — resolves Blocking Data Gap DG001
Detailed mechanism of action data from DrugBank — resolves High-severity Data Gap DG002
Drug-drug interaction data (current query status: not found)
Confirmation of New Zealand registration/market intent, given current status is "Not Marketed"
Clarification of whether this candidate should be tracked as a repurposing opportunity at all, given it reflects an already-approved use rather than a novel indication
Disclaimer

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