Insulin Glulisine

證據等級: L5

預測適應症: 10 個

Insulin Glulisine: From Diabetes Mellitus to Type 1 Diabetes Mellitus

One-Sentence Summary

Insulin glulisine is a rapid-acting insulin analogue used broadly for glycemic control in diabetes mellitus. The TxGNN model predicts it may be effective for Type 1 Diabetes Mellitus, with 50 clinical trials and 19 publications currently supporting this direction — however, this predicted "new" indication substantially overlaps with insulin glulisine's already-established clinical use, so it should be read as evidence-strength validation rather than a genuinely novel repurposing signal.

Quick Overview

Item	Content
Original Indication	Not documented in available regulatory data (Finland: not marketed, no license record); insulin glulisine is generally indicated for prandial glycemic control in diabetes mellitus
Predicted New Indication	Type 1 Diabetes Mellitus
TxGNN Prediction Score	99.55%
Evidence Level	L1
Finland 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. Based on known information, insulin glulisine is a rapid-acting human insulin analogue that binds the insulin receptor to directly restore insulin signaling and lower blood glucose — this is the core pharmacological action shared by all insulin products, not a novel mechanism being newly applied.

Because insulin replacement is the standard-of-care treatment for absolute insulin deficiency, and Type 1 Diabetes Mellitus is defined by autoimmune destruction of pancreatic beta cells leading to exactly that deficiency, the mechanistic link between the drug and the predicted indication is direct and expected rather than exploratory.

Important caveat: the evidence pack's own repurposing rationale flags this explicitly — insulin glulisine already carries labeled use in T1DM in most markets, so this candidate does not represent genuine "old drug, new use" repurposing. The very strong TxGNN score and large trial/literature base reflect the drug's well-established role in T1DM management, not a newly discovered therapeutic application. This candidate is best interpreted as a model-validation/positive-control case rather than a pipeline opportunity.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT00607087	Phase 4	Completed	289	Demonstrated superiority of insulin glulisine over aspart and lispro via CSII pump regarding unexplained hyperglycemia/infusion set occlusion in T1DM
NCT00046150	Phase 3	Completed	59	Multinational comparison of glulisine (HMR1964) vs aspart via CSII pump; safety endpoints (occlusions, HbA1c, hypoglycemia) in T1DM
NCT00115570	Phase 3	Completed	572	26-week trial: glulisine as safe and effective as lispro in children/adolescents with T1DM
NCT00545337	Phase 3	Completed	60	26-week international trial evaluating glulisine + glargine efficacy (HbA1c) and safety in T1DM
NCT00290979	Phase 3	Completed	250	28-week non-inferiority trial: HMR1964 (glulisine) vs lispro in T1DM
NCT00397553	Phase 3	Completed	104	Local efficacy/safety data for glulisine + glargine basal insulin therapy in T1DM
NCT01204593	Phase 4	Completed	206	Basal-bolus therapy (glargine + glulisine) in previously uncontrolled T1DM patients; HbA1c change at 24 weeks
NCT00539448	Phase 4	Completed	98	Open-label multicenter study of glargine + glulisine efficacy and dosing in T1DM
NCT00964574	Phase 4	Completed	68	Efficacy, safety, and patient satisfaction of glulisine + glargine in T1DM
NCT00925977	N/A	Terminated	44	Crossover comparison of treatment satisfaction: glargine + glulisine vs NPH + glulisine in newly diagnosed pediatric T1DM (study terminated)

Literature Evidence

PMID	Year	Type	Journal	Key Findings
16308840	2005	RCT	Horm Metab Res	Multinational randomized parallel-group trial (n=683) comparing efficacy/safety of glulisine vs lispro in adults with T1DM
21457066	2011	RCT	Diabetes Technol Ther	Randomized 3-way crossover trial: glulisine vs aspart vs lispro via CSII in T1DM
21291333	2011	RCT	Diabetes Technol Ther	26-week pediatric trial showing comparable efficacy/safety of glulisine and lispro in basal-bolus regimens
19614947	2009	RCT	Diabetes Obes Metab	Glulisine vs lispro efficacy/safety in Japanese T1DM patients using glargine as basal insulin
41366610	2026	RCT	Diabetes Obes Metab	Phase III randomized trial: biosimilar insulin glulisine (T-Glu) vs originator (R-Glu) — immunogenicity, efficacy, safety in T1DM
28544684	2017	Cohort	Pediatr Int	1-year CSII use of glulisine in 20 children with T1DM; significant improvement in post-meal glucose
19496630	2009	Review	Drugs	Comprehensive review of insulin glulisine's role in diabetes management, including T1DM
16123473	2005	PK/PD Study	Diabetes Care	Pharmacokinetics and prandial glucose control of glulisine vs regular human insulin in pediatric T1DM
18076215	2008	Review	Clin Pharmacokinet	Clinical pharmacokinetics/pharmacodynamics review of insulin glulisine
16706558	2006	Review	Drugs	Review of glulisine's glycemic control efficacy vs regular human insulin in T1DM/T2DM

Safety Considerations

Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Evidence strength is high (L1: multiple completed Phase 3 RCTs directly studying insulin glulisine in T1DM), but the predicted indication substantially overlaps with the drug's already-established clinical use rather than representing a novel repurposing opportunity — guardrails are needed to confirm this is treated as a formal-registration/validation case, not a new therapeutic hypothesis.

To proceed, the following is needed:

TFDA/Fimea package insert warnings, contraindications, and drug interaction data (currently blocking safety pre-screening — DG001)
Confirmed mechanism of action documentation from DrugBank (DG002)
Verification of whether "predicted new indication" reflects a true evidence gap in Finland (0 licenses, not marketed) or simply an unregistered existing-use product, to route this correctly as a market-entry case rather than a repurposing case
Disclaimer

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