Insulin Glulisine

證據等級: L5

預測適應症: 10 個

Insulin Glulisine: From Diabetes Mellitus to Type 1 Diabetes Mellitus (Core Indication, Not a Novel Repurposing Signal)

One-Sentence Summary

Insulin Glulisine (DrugBank DB01309) is a rapid-acting insulin analogue used for glycemic control in diabetes mellitus. The TxGNN model’s top-ranked prediction is Type 1 Diabetes Mellitus, which is important to flag upfront: this is not a novel repurposing hypothesis but the drug’s own core approved use — the model correctly identified the drug-disease relationship, supported by ~50 clinical trials and 19 publications, including several direct Phase 3 pivotal trials.

Quick Overview

Item	Content
Original Indication	Not available (no license records in evidence pack; drug is currently unmarketed in this jurisdiction) — clinically, insulin glulisine’s core use is mealtime glycemic control in diabetes mellitus
Predicted New Indication	Type 1 Diabetes Mellitus
TxGNN Prediction Score	99.55%
Evidence Level	L1
US Market Status	未上市 (Not Marketed)
Number of NDAs	0
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Currently, detailed mechanism of action (MOA) data is not available in this evidence pack (marked as a data gap). Based on known pharmacology, insulin glulisine is a rapid-acting human insulin analogue (modified at positions B3-Lys and B29-Glu) designed to mimic physiological prandial insulin release, providing faster onset and shorter duration of action than regular human insulin.

The relationship between the “original indication” and the “predicted new indication” here requires an important caveat: the repurposing rationale in the evidence pack explicitly notes that Type 1 Diabetes Mellitus is not a repurposing hypothesis at all — it is insulin’s core, label-defining use. The original_indications field is empty due to a data gap (this drug is also not currently marketed under the jurisdiction covered by this evidence pack), which caused the pipeline to surface T1DM as a “new” prediction. The high TxGNN score (99.55%) should be read as the knowledge graph correctly recovering a well-established drug-disease relationship, not as discovery of a novel therapeutic use.

Because T1DM is characterized by absolute endogenous insulin deficiency, exogenous rapid-acting insulin replacement is mechanistically direct and not an extrapolation — this is reflected in the very large, high-quality body of Phase 3 evidence below.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT07070752	Phase 3	Completed	224	Non-inferior immunogenicity, efficacy and safety of a glulisine biosimilar (GP40321) vs. Apidra® SoloStar® in T1DM patients
NCT00467376	Phase 3	Completed	485	Compared efficacy, safety and hypoglycemia frequency of insulin glulisine vs. insulin lispro in T1/T2DM patients also using insulin glargine
NCT00546702	Phase 3	Completed	142	26-week efficacy (HbA1c change) and safety study of insulin glulisine with insulin glargine in T1DM
NCT01194258	Phase 2	Completed	132	Crossover safety/efficacy comparison of prandial insulin formulations including glulisine-class rapid-acting insulins in basal-bolus therapy for T2DM
NCT01594060	Phase 4	Completed	36	Real-world basal-bolus regimen (including glulisine) vs. sliding-scale insulin in hospitalized non-critically ill diabetic patients
NCT02509429	Phase 2	Completed	24	Closed-loop (artificial pancreas) insulin therapy vs. pump therapy for nocturnal hypoglycemia reduction in children with T1DM
NCT01159353	Phase 1	Completed	37	Pharmacodynamic/pharmacokinetic comparison of insulin glulisine vs. insulin aspart post-meal in obese T2DM subjects
NCT02914886	Phase 4	Completed	14	Investigated whether zinc-free insulin glulisine reduces injection-site lipoatrophy in T1DM patients on insulin pump therapy
NCT03495908	N/A	Completed	136	Efficacy/safety of regular human insulin vs. rapid-acting insulin (incl. glulisine) via V-Go wearable delivery device in T2DM
NCT02814123	Phase 2	Completed	28	Closed-loop co-administration of fast-acting insulin (glulisine) with pramlintide for 24-hour glucose regulation in T1DM inpatients

Literature Evidence

PMID	Year	Type	Journal	Key Findings
16308840	2005	RCT	Hormone and Metabolic Research	Pivotal multinational RCT (n=683) comparing insulin glulisine to insulin lispro in adults with T1DM — established efficacy/safety basis for approval
41366610	2026	Phase III RCT	Diabetes, Obesity & Metabolism	Biosimilar insulin glulisine (T-Glu) vs. originator: immunogenicity, efficacy, and safety in T1DM
21457066	2011	RCT	Diabetes Technology & Therapeutics	Randomized 3-way crossover comparing glulisine, aspart and lispro via CSII pump in T1DM, evaluating catheter occlusion rates
19614947	2009	Comparative Study	Diabetes, Obesity & Metabolism	Efficacy and safety of insulin glulisine vs. lispro in Japanese T1DM patients on glargine basal therapy
21291333	2011	Comparative Study	Diabetes Technology & Therapeutics	26-week pediatric trial: comparable efficacy/safety of glulisine vs. lispro in basal-bolus regimen for T1DM children
23425652	2013	Comparative Study	Endocrine Practice	Glulisine vs. aspart for breakfast postprandial glucose control in children with T1DM on MDI
35933650	2022	Comparative Study	Acta Diabetologica	Real-world CSII pump comparison of glulisine vs. lispro/aspart in T1DM, evaluating HbA1c, FBG and hypoglycemia/DKA rates
19496630	2009	Review	Drugs	Comprehensive review of insulin glulisine’s pharmacology and clinical use across diabetes populations
28544684	2017	Cohort	Pediatrics International	1-year efficacy/safety of glulisine via CSII in 20 children with T1DM
16123473	2005	PK/PD Study	Diabetes Care	Pharmacokinetics, prandial glucose control and safety of glulisine vs. regular human insulin in pediatric T1DM

US Market Information

No licenses or authorizations are on record for this drug in the current evidence pack (market status: 未上市 / Not Marketed; total licenses: 0).

Safety Considerations

Please refer to the package insert for safety information. (All safety fields in this evidence pack — key warnings, contraindications, and drug interaction data — are marked as data gaps.)

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: The evidence base for insulin glulisine in Type 1 Diabetes Mellitus is extensive and high quality (L1, multiple completed Phase 3 RCTs including a 2026 biosimilar trial), but this reflects confirmation of the drug’s established, label-defining use rather than a genuine repurposing signal — the “original indication” field was empty due to a data gap, not because T1DM is a new application.

To proceed, the following is needed:

TFDA-equivalent package insert warnings/contraindications (currently a Blocking data gap — required before any S1 safety pre-assessment)
Confirmed original indication and license records, since the drug is currently listed as unmarketed in this jurisdiction
Formal mechanism of action (MOA) documentation from DrugBank
Re-classification review: confirm with the study team whether “Type 1 Diabetes Mellitus” should be excluded from repurposing consideration given it is the drug’s core indication
Disclaimer

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