Insulin Glulisine

證據等級: L5

預測適應症: 10 個

Insulin Glulisine: From Diabetes Mellitus (Established Use) to Type 1 Diabetes Mellitus

One-Sentence Summary

Insulin glulisine is a rapid-acting insulin analogue whose established clinical role is mealtime (bolus) glycemic control in diabetes mellitus. The TxGNN model predicts efficacy for Type 1 Diabetes Mellitus, and this is backed by an unusually large body of evidence — 83 clinical trials and 19 publications in the evidence pack — because this "prediction" largely overlaps with the drug's already-approved therapeutic use rather than representing a novel repurposing hypothesis.

Quick Overview

Item	Content
Original Indication	Not specified in the regulatory dataset (0 licenses on file). As a rapid-acting insulin analogue, its established clinical use is mealtime/bolus glycemic control in diabetes mellitus (Type 1 and Type 2).
Predicted New Indication	Type 1 Diabetes Mellitus
TxGNN Prediction Score	99.55%
Evidence Level	L1
New Zealand Market Status	✗ Not Marketed
Number of Authorizations	0
Recommended Decision	Proceed with Guardrails

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 that acts as an exogenous replacement for endogenous prandial insulin, lowering postprandial blood glucose by promoting peripheral glucose uptake and suppressing hepatic glucose output through the insulin receptor pathway.

Type 1 diabetes mellitus is a disease of absolute insulin deficiency caused by autoimmune β-cell destruction. Exogenous rapid-acting insulin, including glulisine, is the standard-of-care bolus component of basal-bolus therapy in this population — this is not a novel indication discovered through drug repositioning, but the drug's core, already-established pharmacological use.

This has an important implication for interpretation: the evidence pack's own rationale notes that the TxGNN score here reflects real, well-established biology rather than a new repurposing hypothesis. Practically, this means the "prediction" should be read as a validation signal for the model (it correctly recovers a known indication) rather than as a genuine new-market opportunity — the actionable gap is regulatory (the drug is not currently marketed in New Zealand), not scientific.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT00607087	Phase 4	Completed	289	Insulin glulisine vs. aspart and lispro via CSII pump in T1D; assessed unexplained hyperglycemia, infusion set occlusion, and hypoglycemia.
NCT00115570	Phase 3	Completed	572	Glulisine vs. lispro in children/adolescents with T1D over 26 weeks; safety and efficacy comparison.
NCT00290979	Phase 3	Completed	250	Non-inferiority of HMR1964 (glulisine) vs. insulin lispro on HbA1c change in T1D over 28 weeks.
NCT01204593	Phase 4	Completed	206	Basal-bolus therapy (glargine + glulisine) in T1D patients previously uncontrolled on any insulin regimen.
NCT00397553	Phase 3	Completed	104	Efficacy and safety of subcutaneous glulisine with glargine as basal insulin in T1D.
NCT00526513	Phase 4	Completed	188	Apidra (glulisine) combined with basal insulin in T1D and T2D; glycemic control and hypoglycemia incidence.
NCT00539448	Phase 4	Completed	98	Effects of glargine and glulisine in T1D over 26 weeks; HbA1c change and dosing.
NCT00545337	Phase 3	Completed	60	Efficacy and safety of glulisine (HMR1964) with glargine in T1D over 26 weeks.
NCT00964574	Phase 4	Completed	68	Efficacy and safety of subcutaneous glulisine with glargine in T1D, including patient satisfaction.
NCT02518945	Phase 3	Completed	26	Dapagliflozin as add-on to liraglutide and insulin in T1D (insulin as background therapy).

Literature Evidence

PMID	Year	Type	Journal	Key Findings
16308840	2005	RCT	Hormone and Metabolic Research	Multinational RCT (n=672) comparing glulisine to lispro in adults with T1D for efficacy and safety.
41366610	2026	RCT (Phase III)	Diabetes, Obesity & Metabolism	Immunogenicity, efficacy, and safety of a biosimilar glulisine vs. originator product in T1D.
21457066	2011	RCT	Diabetes Technology & Therapeutics	Randomized 3-way crossover comparing glulisine to aspart and lispro via CSII in T1D.
28544684	2017	Cohort	Pediatrics International	1-year evaluation of glulisine via CSII in 20 children with T1D; improved postprandial glucose.
16123473	2005	Cohort	Diabetes Care	Pharmacokinetics, prandial glucose control, and safety of glulisine vs. regular human insulin in pediatric T1D.
19496630	2009	Review	Drugs	Comprehensive review of glulisine's role in diabetes management.
18076215	2008	Review	Clinical Pharmacokinetics	Review of clinical pharmacokinetics and pharmacodynamics of glulisine.
19614947	2009	Comparative Study	Diabetes, Obesity & Metabolism	Efficacy and safety of glulisine vs. lispro in Japanese patients with T1D.
35933650	2022	Observational	Acta Diabetologica	Real-world comparison of glulisine, lispro, and aspart for CSII pump treatment in T1D.
29159123	2016	PK/PD Study	Journal of Clinical & Translational Endocrinology	Pharmacokinetics/pharmacodynamics of glargine-glulisine basal-bolus therapy in T1D across standardized meals.

New Zealand Market Information

Insulin glulisine currently holds no product licenses in New Zealand (0 authorizations, market status: not marketed).

Safety Considerations

Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: The clinical trial and literature base for glulisine in T1D is extensive and mature (L1 evidence, multiple completed Phase 3/4 trials), but this reflects confirmation of an already-established core indication rather than a genuine repurposing discovery — the drug is not currently marketed in New Zealand, so the practical barrier is regulatory, not scientific.

To proceed, the following is needed:

Medsafe/NZ package insert data (warnings, contraindications, DDI) — currently a Blocking data gap (DG001)
Detailed mechanism of action documentation from DrugBank (DG002)
A formal NZ market-entry/registration assessment, since this is not a novel indication but an unmarketed product gap
Clarification that lower-ranked predicted indications (ranks 2–10, all L4–L5) are not being pursued: several (e.g., lipodystrophy-related diagnoses) likely reflect insulin as a causative factor rather than a treatment, and should be flagged as safety signals rather than repurposing candidates
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.