Insulin Glulisine
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Insulin Glulisine: From Diabetes Mellitus (General) to Type 1 Diabetes Mellitus
One-Sentence Summary
Insulin glulisine (Apidra) is a rapid-acting human insulin analogue whose established clinical role is glycemic control in diabetes mellitus. The TxGNN model predicts it is effective for Type 1 Diabetes Mellitus, supported by ~70 clinical trials and 20 publications. Important caveat: this is not a novel repurposing signal — T1DM is already the drug's core, licensed use; the model has essentially re-identified its known indication rather than surfaced a new one.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not extractable from license data (data gap — no Norway licenses on file); by known pharmacology, insulin glulisine is used for glycemic control in diabetes mellitus |
| Predicted New Indication | Type 1 Diabetes Mellitus |
| TxGNN Prediction Score | 99.55% |
| Evidence Level | L1 (≥2 completed Phase 3 RCTs) |
| Norway Market Status | Not Marketed |
| Number of Authorizations | 0 |
| Recommended Decision | Proceed with Guardrails — but see caveat: this confirms established use, it is not a repurposing opportunity |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available (data gap). Based on known pharmacology, insulin glulisine is a recombinant rapid-acting human insulin analogue (modified at B3/B29) that binds the insulin receptor to promote peripheral glucose uptake and suppress hepatic glucose output, mimicking physiological mealtime (bolus) insulin secretion.
Type 1 diabetes mellitus is characterized by absolute insulin deficiency due to autoimmune β-cell destruction; exogenous insulin replacement — including rapid-acting analogues like glulisine — is the foundational, guideline-standard treatment, not an emerging or repurposed use. The evidence pack's own repurposing rationale explicitly flags this: "Insulin glulisine directly replaces the deficient insulin secretion in Type 1 diabetes patients; this is a core pharmacological action, not a drug repurposing scenario."
Practically, this means the very large body of clinical trial and literature evidence below should be read as validation of an already-established indication, not discovery of a new one. The high TxGNN score and L1 evidence level reflect the strength of the drug-disease association in the underlying knowledge graph, which is expected and appropriate for a drug's primary indication.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00607087 | Phase 4 | Completed | 289 | Glulisine superior to aspart/lispro via CSII pump in reducing unexplained hyperglycemia and infusion-set occlusion in T1DM |
| NCT00965549 | Phase 4 | Completed | 463 | Basal-plus-one glulisine regimen non-inferior to biphasic insulin for HbA1c control |
| NCT00115570 | Phase 3 | Completed | 572 | Glulisine as safe/effective as lispro in children and adolescents with T1DM over 26 weeks |
| NCT00290979 | Phase 3 | Completed | 250 | Glulisine non-inferior to lispro on HbA1c change in T1DM, 28-week study |
| NCT00135096 | Phase 3 | Completed | 345 | Pre-meal vs post-meal glulisine dosing with glargine basal insulin, weight change outcomes |
| NCT01204593 | Phase 4 | Completed | 206 | Glargine + glulisine basal-bolus therapy in previously uncontrolled T1DM patients |
| NCT00545337 | Phase 3 | Completed | 60 | Efficacy/safety of glulisine with glargine basal insulin in T1DM (HbA1c, AE, labs) |
| NCT00397553 | Phase 3 | Completed | 104 | Local efficacy/safety data for glulisine + glargine in T1DM |
| NCT00539448 | Phase 4 | Completed | 98 | Open-label evaluation of glargine + glulisine dosing and safety in T1DM |
| NCT02518945 | Phase 3 | Completed | 26 | Glulisine used as background insulin therapy while testing dapagliflozin add-on in T1DM |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 16308840 | 2005 | RCT | Horm Metab Res | Multicenter RCT comparing glulisine to lispro in adults with T1DM (n=672); comparable efficacy and safety |
| 41366610 | 2026 | Phase III RCT | Diabetes Obes Metab | Biosimilar glulisine shows comparable immunogenicity, efficacy, and safety to originator in T1DM |
| 21457066 | 2011 | RCT | Diabetes Technol Ther | Randomized crossover: glulisine vs aspart vs lispro via CSII in T1DM |
| 21291333 | 2011 | RCT | Diabetes Technol Ther | 26-week trial: glulisine comparable efficacy/safety to lispro in pediatric basal-bolus regimen |
| 19614947 | 2009 | RCT | Diabetes Obes Metab | Glulisine vs lispro with glargine basal insulin in Japanese T1DM patients |
| 19496630 | 2009 | Review | Drugs | Comprehensive review of glulisine's role in diabetes management |
| 18076215 | 2008 | PK/PD Study | Clin Pharmacokinet | Clinical PK/PD profile of glulisine vs regular human insulin |
| 16123473 | 2005 | PK/PD Study | Diabetes Care | PK, postprandial glucose control, and safety of glulisine in pediatric T1DM |
| 28544684 | 2017 | Cohort | Pediatr Int | 1-year CSII use of glulisine improves post-meal glucose in pediatric T1DM |
| 35933650 | 2022 | Comparative Study | Acta Diabetol | Real-world comparison of glulisine, lispro, aspart via CSII pump in T1DM |
Norway Market Information
No marketed authorizations are currently on file — 0 licenses, market status Not Marketed. No product name, dosage form, or approved indication text is available in the evidence pack for Norway.
Safety Considerations
Please refer to the package insert for safety information. (No key warnings, contraindications, or drug interaction data are currently available for this evidence pack; TFDA/Norway label data is flagged as a blocking data gap.)
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: The evidence base is strong (L1 — multiple completed Phase 3 RCTs plus extensive Phase 4 and observational data) and unambiguously supports insulin glulisine's efficacy in Type 1 Diabetes Mellitus. However, this is not a repurposing candidate in the traditional sense — T1DM is the drug's established primary indication, and the TxGNN prediction essentially reconfirms known pharmacology rather than identifying a new therapeutic opportunity. The relevant "guardrail" here is regulatory, not clinical: the drug is not currently marketed in Norway.
To proceed, the following is needed:
- Obtain TFDA/Norway product label (warnings, contraindications, DDI) — currently a blocking data gap (DG001)
- Obtain formal MOA documentation from DrugBank (DG002)
- If commercial launch in Norway is the actual goal, this should be pursued as a standard marketing authorization application using the existing global T1DM evidence base, not as a repurposing workflow
- Lower-confidence signals (ranks 2–10: e.g. thiamine-responsive dysfunction syndrome, pancreatic agenesis) remain at L5/Research-Question or Hold status and would require dedicated literature/trial searches before any further evaluation
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.