Insulin Aspart
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
Insulin Aspart: Autoimmune oophoritis
One-Sentence Summary
Insulin aspart is a rapid-acting insulin analogue, originally used to treat diabetes mellitus and diabetic ketoacidosis. The TxGNN model (deep learning) predicts it is effective for autoimmune oophoritis, with 30 clinical trials and 20 publications currently supporting this direction. Type 1 diabetes is a core, already-established use of insulin, so this prediction largely confirms existing practice rather than opening a new therapeutic area.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Autoimmune oophoritis |
| TxGNN Prediction Score | 0.9992 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 9 of 10; dormant: 1) |
| Number of DINs | 10 (marketed: 9) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, insulin aspart is a rapid-acting human insulin analogue. It acts on the insulin receptor to replace deficient endogenous insulin, and it is absorbed faster than regular human insulin after subcutaneous injection.
Type 1 diabetes is defined by absolute insulin deficiency, which is the situation insulin replacement is designed to correct. The original indication (diabetes mellitus) already includes type 1 diabetes. The prediction is therefore an on-label use, not true repurposing, and the high TxGNN score is consistent with the known pharmacology.
Clinical Trial Evidence
The data compiled for this report list 30 trials. The 10 most relevant are shown below, prioritising completed Phase 3 trials directly involving insulin aspart.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00097071 | Phase 3 | Completed | 299 | Insulin aspart vs insulin lispro in insulin pumps in children and adolescents with T1DM |
| NCT02825251 | Phase 3 | Completed | 472 | Faster-acting insulin aspart vs NovoRapid by continuous subcutaneous infusion in adults with T1DM |
| NCT00595374 | Phase 3 | Completed | 114 | Insulin detemir + aspart vs NPH + aspart in adults with T1DM |
| NCT01520818 | Phase 3 | Completed | 666 | Biphasic insulin aspart 50/70 vs biphasic human insulin 30 in T1DM or T2DM |
| NCT01467323 | Phase 3 | Completed | 303 | Biphasic insulin aspart 30 vs biphasic human insulin 30/70, twice daily, in T1DM and T2DM |
| NCT00725036 | Phase 3 | Completed | 305 | Long-term safety of inhaled human insulin vs subcutaneous aspart (both with NPH) in T1DM |
| NCT00322257 | Phase 3 | Terminated | 596 | Inhaled mealtime insulin vs subcutaneous aspart (with detemir) in T1DM, efficacy and pulmonary safety |
| NCT01999322 | Phase 3 | Completed | 37 | Compatibility and safety of faster aspart and aspart with an external insulin pump in adults with T1DM |
| NCT01848990 | Phase 4 | Completed | 456 | Hyaluronidase pre-administration in continuous subcutaneous insulin infusion in T1DM; HbA1c at 6 months |
| NCT00593255 | Phase 4 | Completed | 220 | Insulin aspart vs human soluble insulin for postprandial glucose in Chinese patients with T1DM and T2DM |
Literature Evidence
The data compiled for this report list 20 publications. The 10 most relevant are shown below.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27362975 | 2016 | Systematic Review | Cochrane Database Syst Rev | Short-acting insulin analogues vs regular human insulin in adults with T1DM |
| 25644227 | 2015 | Systematic Review/Meta-analysis | Pol Arch Med Wewn | Efficacy and safety of insulin aspart vs regular human insulin in T1DM and T2DM |
| 21333580 | 2011 | Systematic Review | Diabetes Metab | Insulin aspart vs regular human insulin in T1DM and T2DM |
| 23243636 | 2012 | Systematic Review | Drugs Today | Insulin analogues, including aspart, for T1DM in children and adolescents |
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | Degludec vs detemir, both with aspart, in pregnant women with T1DM (EXPECT) |
| 37863084 | 2023 | RCT | Lancet | Once-weekly icodec vs once-daily degludec in a basal-bolus regimen in T1DM (ONWARDS 6) |
| 40445776 | 2025 | RCT | Diabetes Technol Ther | Fully closed-loop delivery with faster aspart in adolescents with T1DM above HbA1c target |
| 12215068 | 2002 | Review | Drugs | Review of insulin aspart in T1DM and T2DM; mealtime dosing lowered HbA1c more than regular human insulin |
| 15871555 | 2003 | Review | Treat Endocrinol | Spotlight on insulin aspart in T1DM and T2DM |
| 29978361 | 2019 | Review | Clin Pharmacokinet | Faster insulin aspart as a new bolus option, with greater glucose lowering at 20 minutes |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02506564 | TRURAPI | Not listed | Not listed |
| 02529254 | TRURAPI | Not listed | Not listed |
| 02460424 | FIASP | Not listed | Not listed |
| 02460408 | FIASP | Not listed | Not listed |
| 02245397 | NOVORAPID | Not listed | Not listed |
Ten valid DINs are authorised in total (TRURAPI, FIASP, NOVORAPID, KIRSTY, NOVOMIX 30). Only the first five are shown.
Safety Considerations
Please refer to the package insert for safety information.
Among the lower-ranked TxGNN predictions, injection-site localized lipodystrophy is a known adverse effect of injected insulin, and should be considered a safety signal.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Multiple completed Phase 3 trials and several systematic reviews support insulin aspart in type 1 diabetes, and the product is already marketed in Canada. Because this is an on-label use, the main gap is the missing label-based safety information, not efficacy.
To proceed, the following is needed:
- Health Canada package insert warnings and contraindications (currently missing and blocking the safety screening)
- Detailed mechanism of action data from DrugBank
- Approved indication text and dosage forms for each DIN
- A review of the other predicted indications (e.g., autoimmune oophoritis, stiff person syndrome), which lack any clinical evidence and should stay on Hold
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.