Insulin Aspart
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
- Insulin Aspart
- Insulin Aspart: Type 1 Diabetes Mellitus as a Predicted Indication (Original Indication Not Recorded)
Insulin Aspart: Type 1 Diabetes Mellitus as a Predicted Indication (Original Indication Not Recorded)
One-Sentence Summary
Insulin aspart is a rapid-acting insulin analogue given by injection. The TxGNN model predicts it for type 1 diabetes mellitus (T1DM), supported by 50 clinical trials and 20 publications. T1DM is very likely already an approved (on-label) use, so this is probably not true repurposing. The original indication is blank in the supplied data.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Type 1 diabetes mellitus |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L1 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 2 |
| Recommended Decision | Proceed with Guardrails |
The original indication is omitted because neither the SAHPRA records nor DrugBank in the Evidence Pack provide one.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Insulin aspart is a rapid-acting human insulin analogue. It replaces the endogenous insulin that is absent in T1DM and is given around meals.
The prediction is biologically straightforward, since T1DM is defined by insulin deficiency. The trials and reviews below show aspart used as the mealtime insulin in T1DM. The blank original-indication field most likely reflects a data-completeness problem, not a new use.
Before this is presented as a repurposing candidate, confirm the approved label against the SAHPRA Professional Information (PI) or DrugBank.
Clinical Trial Evidence
Of the 50 trials retrieved, the 10 most relevant are listed. Most are Phase 3 or 4 T1DM studies in which aspart is the mealtime or comparator insulin, so they support use in T1DM but do not test aspart against a placebo.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03760068 | Phase 3 | Completed | 478 | MYL-1601D (an insulin aspart product) vs NovoLog in T1DM: safety and efficacy equivalence |
| NCT01835431 | Phase 3 | Completed | 362 | Degludec/aspart plus mealtime aspart vs detemir plus aspart in children and adolescents with T1DM |
| NCT01445951 | Phase 3 | Completed | 518 | Inhaled Technosphere insulin vs insulin aspart, each with basal insulin, over 24 weeks |
| NCT00978627 | Phase 3 | Completed | 548 | Degludec/aspart plus aspart vs detemir plus aspart in T1DM, with a long-term safety extension |
| NCT04079413 | Phase 3 | Completed | 264 | GP40071 (an insulin aspart product) vs NovoRapid Penfill in adults with T1DM |
| NCT04974528 | Phase 3 | Completed | 319 | Inhaled Afrezza vs rapid-acting analogue injections, including aspart, in paediatric T1DM/T2DM |
| NCT01848990 | Phase 4 | Completed | 456 | Hyaluronidase pre-treatment of the infusion site in T1DM using insulin pumps (CSII) with aspart |
| NCT00365170 | Phase 4 | Completed | 419 | Aspart (NovoRapid) vs human insulin in pregnant women with T1DM: maternal hypoglycaemia and pregnancy outcomes |
| NCT01697657 | Phase 3 | Completed | 131 | Detemir vs NPH, both with mealtime aspart, in T1DM; hypoglycaemia frequency (sites included Africa) |
| NCT00888732 | Phase 3 | Completed | 24 | Pharmacokinetic and pharmacodynamic comparison of aspart, biphasic aspart and human insulin in T1DM |
No SANCTR or PACTR identifiers were found in the supplied data.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | Degludec vs detemir, both with aspart, in pregnant women with T1DM (EXPECT) |
| 37804858 | 2023 | RCT | Lancet Diabetes Endocrinol | Faster-acting aspart vs aspart in T1DM/T2DM during pregnancy and post-delivery (CopenFast) |
| 37863084 | 2023 | RCT | Lancet | Icodec vs degludec as part of a basal-bolus regimen in T1DM (ONWARDS 6) |
| 40129237 | 2025 | RCT | Diabetes Obes Metab | Faster aspart vs aspart in adults with T1DM using a non-automated pump and CGM |
| 21333580 | 2011 | Systematic review | Diabetes Metab | Aspart vs regular human insulin in T1DM and T2DM |
| 12215068 | 2002 | Review | Drugs | Aspart lowered HbA1c more than regular human insulin in most T1DM trials |
| 15871555 | 2003 | Review | Treat Endocrinol | Summary of aspart in T1DM and T2DM |
| 39115159 | 2024 | Cohort (post hoc) | Diabet Med | Aspart vs other bolus insulins in pregnant women with T1DM |
| 31902063 | 2020 | Review | Diabetes Ther | Insulin management strategies for adults with T1DM |
| 25143741 | 2014 | Review | Vasc Health Risk Manag | Degludec/aspart combination in T1DM and T2DM |
South Africa Market Information
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| Reg. No. 34/21.1/0160 | NovoRapid Penfill 3 ml | Injection |
| Reg. No. 47/21.1/0165 | Ryzodeg FlexTouch pre-filled pen 3 ml | Injection |
The supplied records give no approved-indication text or manufacturer for either registration. Essential Medicines List (EML) status is not stated in the data. Ryzodeg is a degludec/aspart combination, so its indications may differ from those of NovoRapid.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA. No warnings, contraindications or interaction data were available in the Evidence Pack.
Two points from the evidence review are worth noting:
- Injection-site lipodystrophy (lipoatrophy or lipohypertrophy) is a recognised effect of repeated insulin injections at the same site.
- Hypoglycaemia is the main clinical risk of insulin therapy. It needs particular attention in neonates, infants and pregnancy.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Several completed Phase 3 trials and RCT, systematic-review and review literature support insulin aspart in T1DM (L1). T1DM is probably an existing approved use, so this should not be presented as new repurposing until the label is confirmed.
To proceed, the following is needed:
- Confirm the approved indications in the SAHPRA PI for both registrations. This is a blocking gap.
- Obtain warnings, contraindications and interaction data from the PI.
- Add mechanism of action data from DrugBank.
- Record the original indication and check whether the two products differ in label.
Other predictions (ranks 2–10):
- Permanent neonatal diabetes and pancreatic agenesis are biologically plausible but have only indirect evidence, and are flagged as research questions.
- The remaining predictions are Hold. Autoimmune oophoritis and the stiff-person disorders appear to reflect T1DM comorbidity, not benefit from insulin.
- Drug-induced localized lipodystrophy is an adverse effect of injected insulin, not a treatment target, and should be excluded.
This report is for research reference only and does not constitute medical advice. Predicted indications require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.