Insulin Aspart
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Insulin Aspart: From Diabetes Mellitus to Type 1 Diabetes Mellitus
One-Sentence Summary
Insulin aspart is a rapid-acting insulin analogue, originally used to treat diabetes mellitus and diabetic ketoacidosis. The TxGNN model predicts it may be effective for type 1 diabetes mellitus, with 30 clinical trials and 20 publications currently supporting this direction. This is an established, labelled use of the drug rather than a true repurposing, so the high score mainly reflects existing clinical evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Diabetes mellitus; diabetic ketoacidosis |
| Predicted New Indication | Type 1 diabetes mellitus |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L1 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 8 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, insulin aspart is a rapid-acting human insulin analogue. It is absorbed faster than regular human insulin after subcutaneous injection, and its efficacy in diabetes mellitus is well established.
Type 1 diabetes is characterised by absolute insulin deficiency, so replacing insulin is mechanistically direct. Insulin aspart is widely used as the mealtime (bolus) insulin in basal-bolus regimens, in insulin pumps (CSII), and in closed-loop systems. The link between the original indication and the predicted indication is therefore very close. The high TxGNN score is consistent with the extensive clinical evidence, and this should be viewed as confirmation of an existing use, not a new therapeutic discovery.
Clinical Trial Evidence
The data compiled for this report include 30 trials. The table lists the 10 most relevant, prioritising Phase 3 trials with direct evidence for 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 type 1 diabetes |
| NCT02825251 | Phase 3 | Completed | 472 | Faster-acting insulin aspart vs NovoRapid® by CSII in adults with type 1 diabetes |
| NCT00595374 | Phase 3 | Completed | 114 | Insulin detemir + aspart vs NPH + aspart in adults with type 1 diabetes |
| NCT00322257 | Phase 3 | Terminated | 596 | Inhaled mealtime insulin vs subcutaneous insulin aspart (both with detemir), efficacy and pulmonary safety over 104 weeks |
| NCT00725036 | Phase 3 | Completed | 305 | Long-term safety of inhaled human insulin vs subcutaneous insulin aspart (both with NPH) |
| NCT01520818 | Phase 3 | Completed | 666 | Biphasic insulin aspart 50/70 vs biphasic human insulin 30 in type 1 or type 2 diabetes |
| NCT01467323 | Phase 3 | Completed | 303 | Biphasic insulin aspart 30 vs biphasic human insulin 30/70, twice daily, in type 1 and type 2 diabetes |
| NCT01999322 | Phase 3 | Completed | 37 | Compatibility and safety of faster aspart (FIAsp) and insulin aspart with an external insulin pump |
| NCT01486381 | Phase 3 | Completed | 22 | Long-term safety extension of biphasic insulin aspart 30 in young people with type 1 diabetes |
| NCT01848990 | Phase 4 | Completed | 456 | Hyaluronidase pre-administration with CSII: HbA1c and safety outcomes in type 1 diabetes |
Literature Evidence
The table lists the 10 most relevant publications, prioritising RCTs and systematic reviews.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | Degludec vs detemir, both with insulin aspart, in pregnant women with type 1 diabetes (non-inferiority trial) |
| 37863084 | 2023 | RCT | Lancet | Once-weekly icodec vs once-daily degludec in a basal-bolus regimen in type 1 diabetes (ONWARDS 6) |
| 40445776 | 2025 | RCT | Diabetes Technol Ther | Fully closed-loop delivery with faster insulin aspart improved glycaemic control in adolescents with type 1 diabetes |
| 27362975 | 2016 | Cochrane systematic review | Cochrane Database Syst Rev | Short-acting insulin analogues vs regular human insulin in adults with type 1 diabetes |
| 23243636 | 2012 | Systematic review | Drugs Today (Barc) | Insulin analogues, including rapid-acting aspart, for type 1 diabetes in children and adolescents |
| 25644227 | 2015 | Systematic review / meta-analysis | Pol Arch Med Wewn | Clinical efficacy and safety of insulin aspart vs regular human insulin in type 1 and type 2 diabetes |
| 21333580 | 2011 | Systematic review | Diabetes Metab | Efficacy and safety comparison of insulin aspart and regular human insulin |
| 12215068 | 2002 | Review | Drugs | Insulin aspart given before meals gave lower HbA1c than regular human insulin in type 1 diabetes |
| 15329046 | 2004 | Review | Drugs | Insulin aspart gave better HbA1c and postprandial control than regular human insulin in basal-bolus regimens |
| 29978361 | 2019 | Review | Clin Pharmacokinet | Faster insulin aspart as a new bolus option, with greater early glucose-lowering effect |
Singapore Market Information
The data compiled for this report list 8 valid single-ingredient registrations. The approved indication text is not available for any of them. The five main authorizations are shown below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN12189P | NovoRapid FlexPen Injection 100 u/ml | Injection | Not stated in registration data |
| SIN11394P | NovoRapid Penfill Injection 100 u/ml | Injection | Not stated in registration data |
| SIN15995P | Fiasp Solution for Injection in Vial 100U/ml | Injection, solution | Not stated in registration data |
| SIN15994P | Fiasp FlexTouch 100U/ml | Injection, solution | Not stated in registration data |
| SIN15480P | NovoMix® 30 Penfill® 100 U/ml | Injection, suspension | Not stated in registration data |
Other registrations: Kirsty™ (SIN16868P pre-filled pen, SIN16867P vial) and Ryzodeg® FlexTouch® (SIN15706P).
Safety Considerations
Please refer to the package insert for safety information. Interaction and contraindication data were not available for this report.
Other predicted indications also raise a safety point. The model's prediction of drug-induced localised lipodystrophy is more likely an adverse effect of insulin injections (lipohypertrophy/lipoatrophy) than a therapeutic use. It should be treated as a safety signal, such as injection-site rotation, not as a repurposing opportunity.
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 it is already marketed in Singapore under 8 registrations. Evidence is strong (L1), but this is an established use rather than a new one, and the safety information has gaps.
To proceed, the following is needed:
- Package insert warnings and contraindications from HSA (currently missing and blocking safety screening)
- Confirmation of the approved indication wording on each Singapore registration
- Detailed mechanism of action data
- A review of the other predicted indications. Several are computational predictions only (for example autoimmune oophoritis, opsismodysplasia, stiff person syndrome, centrifugal lipodystrophy) and should be held. Permanent neonatal diabetes and pancreatic agenesis are mechanistically plausible, but the evidence is indirect or limited to a single review.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.