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. This is in practice an established, on-label use rather than true repurposing.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (12 of 12) – CDSCO approval status is not included in this data |
| Number of Listed Products | 12 (valid: 12) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Insulin aspart is a rapid-acting insulin analogue. It binds the insulin receptor and replaces deficient endogenous insulin, lowering blood glucose. Currently, detailed mechanism of action data is not available in the data compiled for this report, so this description rests on the known pharmacology of the drug class.
Type 1 diabetes is caused by autoimmune loss of beta cells, which leads to absolute insulin deficiency. Insulin replacement is therefore the core treatment, and insulin aspart is widely used in basal-bolus regimens, pumps and closed-loop systems. The high TxGNN score is consistent with the extensive clinical evidence below.
Clinical Trial Evidence
The data include 30 registered trials. The most relevant ones are listed below.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00097071 | Phase 3 | Completed | 299 | Insulin aspart vs insulin lispro in 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 | Detemir + aspart vs NPH + aspart in adults with T1D |
| NCT01848990 | Phase 4 | Completed | 456 | CSII study in T1D; supports real-world effectiveness |
| NCT01486381 | Phase 3 | Completed | 22 | Long-term safety extension of biphasic insulin aspart 30 in young people with 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 |
| NCT00322257 | Phase 3 | Terminated | 596 | Inhaled mealtime insulin vs subcutaneous aspart, both with detemir, in T1D |
| NCT00725036 | Phase 3 | Completed | 305 | Long-term safety of inhaled human insulin vs subcutaneous aspart in T1D |
| NCT04055480 | N/A | Completed | 25 | Home closed-loop with faster aspart vs standard aspart |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | Degludec vs detemir, both with aspart, in pregnant women with T1D |
| 37863084 | 2023 | RCT | Lancet | Once-weekly icodec vs once-daily degludec in a basal-bolus regimen in T1D |
| 40445776 | 2025 | RCT | Diabetes Technol Ther | Fully closed-loop with faster aspart improved glycaemic control in adolescents with T1D |
| 27362975 | 2016 | Cochrane systematic review | Cochrane Database Syst Rev | Short-acting insulin analogues vs regular human insulin in adults with T1D |
| 25644227 | 2015 | Systematic review / meta-analysis | Pol Arch Med Wewn | Aspart vs regular human insulin in T1D and T2D |
| 21333580 | 2011 | Systematic review | Diabetes Metab | Efficacy and safety of aspart vs regular human insulin |
| 23243636 | 2012 | Systematic review | Drugs Today | Insulin analogues for T1D in children and adolescents |
| 15329046 | 2004 | Review | Drugs | Aspart gave better HbA1c and postprandial control than regular human insulin |
| 12215068 | 2002 | Review | Drugs | Aspart lowered HbA1c more than regular human insulin in T1D |
| 29978361 | 2019 | Review | Clin Pharmacokinet | Faster aspart as a new bolus option, with greater early glucose lowering |
India Market Information
Approved indication text is not available for these licences.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 150300 | Novorapid Penfill | Penfill 3 ml solution for injection | Not available |
| 150335 | Novomix 30 Flexpen 100IU/ml | Flexpen 3 ml suspension for injection | Not available |
| 150445 | Novorapid 100IU Injection | Vial 10 ml injection | Not available |
| 150685 | Novorapid FlexPen | Pre-filled pen 3 ml solution for injection | Not available |
| 84212 | Fiasp FlexTouch | Pre-filled pen 3 ml solution for injection | Not available |
All 12 licences are valid products from Novo Nordisk India Pvt Ltd.
Review correction (2026-11-06): Originally stated: “All 12 licences are valid, single-ingredient products from Novo Nordisk India Pvt Ltd.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.
Safety Considerations
Please refer to the package insert for safety information.
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 India under 12 licences. The indication is established, but the package-insert safety data have not been reviewed.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India licences, plus the approved indication text
- Detailed mechanism of action data
- Confirmation of the approved indication wording for each India product
Other predicted indications: The remaining predictions have little or no supporting evidence.
- Permanent neonatal diabetes mellitus and pancreatic agenesis are mechanistically plausible (insulin deficiency) but supported only by indirect literature, so they remain research questions.
- The other predictions (e.g. autoimmune oophoritis, stiff person syndrome, lipodystrophies) have no clinical evidence and likely reflect network associations. Drug-induced localized lipodystrophy is a known adverse effect of insulin injection. These should be held.
Review Log
Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.
| Review date | Item | Action | Source |
|---|---|---|---|
| 2026-11-06 | Removed: “single-ingredient” | Corrected | Indian Medicine Dataset |
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.