Insulin Aspart
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
- Insulin Aspart
- Pharmacist Assessment Report
- Insulin Aspart: Autoimmune oophoritis
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Other Predicted Indications (Lower Priority)
- Disclaimer
Insulin Aspart: Autoimmune oophoritis
One-Sentence Summary
Insulin aspart is a rapid-acting human insulin analogue, originally used to treat diabetes mellitus and diabetic ketoacidosis. with 32 clinical trials and 20 publications currently supporting this direction.
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 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
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 insulin analogue. It replaces deficient endogenous insulin by binding the insulin receptor, promoting peripheral glucose uptake and suppressing hepatic glucose output.
Type 1 diabetes is characterised by autoimmune destruction of pancreatic beta cells and absolute insulin deficiency. Insulin replacement is therefore a direct mechanistic match. Because the original indication is diabetes mellitus, this prediction is effectively an on-label use rather than a genuine repurposing opportunity.
Clinical Trial Evidence
The data include 32 registered trials. The table lists the most relevant ones, prioritising those graded as directly relevant and large Phase 3 studies.
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT00097071 | Phase 3 | Completed | 299 | Insulin aspart vs insulin lispro in insulin pumps in children and adolescents with T1D |
| NCT02825251 | Phase 3 | Completed | 472 | Faster-acting insulin aspart vs NovoRapid in CSII in adults with T1D |
| NCT00595374 | Phase 3 | Completed | 114 | Insulin detemir + aspart vs NPH + aspart in adults with T1D |
| NCT00322257 | Phase 3 | Terminated | 596 | Inhaled mealtime insulin vs subcutaneous insulin aspart (with detemir) in T1D over 104 weeks |
| NCT00725036 | Phase 3 | Completed | 305 | Long-term safety of inhaled human insulin vs subcutaneous aspart (both with NPH) in T1D |
| NCT00447382 | Phase 3 | Completed | 330 | Two detemir manufacturing processes, with aspart as bolus insulin, in T1D |
| NCT01520818 | Phase 3 | Completed | 666 | Biphasic insulin aspart 50/70 vs biphasic human insulin 30 in T1D or T2D |
| NCT01467323 | Phase 3 | Completed | 303 | Biphasic insulin aspart 30 vs biphasic human insulin 30/70 in T1D or T2D |
| NCT01848990 | Phase 4 | Completed | 456 | Hyaluronidase pre-administration in CSII in T1D (HbA1c and safety); supportive post-marketing evidence |
| NCT04055480 | N/A | Completed | 25 | Home closed-loop with faster aspart vs standard aspart (crossover) |
No ANZCTR identifiers were included in the data compiled for this report. Note that one Phase 3 trial (NCT00725036) was conducted in Oceania.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27362975 | 2016 | Systematic review (Cochrane) | Cochrane Database Syst Rev | Short-acting insulin analogues vs regular human insulin in adults with T1D |
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | Degludec vs detemir, both with aspart, in pregnant women with T1D (EXPECT) |
| 37863084 | 2023 | RCT | Lancet | Once-weekly icodec vs once-daily degludec in a basal-bolus regimen in T1D (ONWARDS 6) |
| 40445776 | 2025 | RCT | Diabetes Technol Ther | Fully closed-loop with faster aspart in adolescents with T1D above HbA1c target |
| 25644227 | 2015 | Systematic review and meta-analysis | Pol Arch Med Wewn | Insulin aspart vs regular human insulin in T1D and T2D |
| 21333580 | 2011 | Systematic review | Diabetes Metab | Efficacy and safety of insulin aspart vs regular human insulin |
| 12215068 | 2002 | Review | Drugs | Insulin aspart gave lower HbA1c than regular human insulin in most T1D trials |
| 15871555 | 2003 | Review | Treatments in Endocrinology | Spotlight on insulin aspart in T1D and T2D |
| 29978361 | 2019 | Review | Clin Pharmacokinet | Faster insulin aspart pharmacokinetics and pharmacodynamics as a bolus option |
| 31902063 | 2020 | Narrative review | Diabetes Ther | Insulin management strategies in adults with T1D |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 12254Y | NovoRapid FlexPen | Injection (human analogue), cartridges, 100 units per mL, 3 mL | Not available in the data compiled for this report |
Safety Considerations
No safety data were available in the data compiled for this report, and no drug interactions were found. Please refer to the TGA-approved Product Information (PI) for safety information.
Standard clinical vigilance is expected for insulin therapy, including hypoglycaemia monitoring and dose titration. Injection-site lipodystrophy is a known effect of repeated insulin injection at the same site, so site rotation is advisable.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Multiple completed Phase 3 trials in type 1 diabetes, supported by Cochrane and other systematic reviews, show that insulin aspart is effective in this population. As this is effectively an on-label use, the main requirements are standard insulin safety practices.
To proceed, the following is needed:
- Confirmation of the approved indication text and safety information from the TGA-approved PI
- Mechanism of action data
- A hypoglycaemia monitoring and dose titration plan appropriate to the regimen (basal-bolus, pump or closed-loop)
Other Predicted Indications (Lower Priority)
The remaining predictions have little or no supporting evidence and are not recommended for progression.
| Predicted Indication | Evidence Level | Decision | Comment |
|---|---|---|---|
| Permanent neonatal diabetes mellitus | L4 | Research question | Insulin replacement is mechanistically coherent and standard care, though sulfonylureas are preferred in some genetic subtypes. Evidence is one review (PMID 28527303) |
| Pancreatic agenesis | L5 | Research question | Insulin replacement is logical, but the supplied literature is indirect only |
| Autoimmune oophoritis | L5 | Hold | No mechanistic link, no trials or publications |
| Opsismodysplasia | L5 | Hold | Pathway link is theoretical only |
| Thiamine-responsive dysfunction syndrome | L5 | Hold | Thiamine is the primary treatment |
| Classic stiff person syndrome, focal stiff limb syndrome | L5 | Hold | Reflects autoimmune comorbidity with T1D, not a treatment rationale |
| Drug-induced localised lipodystrophy, centrifugal lipodystrophy | L5 | Hold | Localised lipodystrophy is an adverse effect of injected insulin, so this is a safety concern rather than an opportunity |
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.