Insulin Degludec

證據等級: L5

預測適應症: 6 個

Insulin Degludec: From Diabetes Mellitus to Type 1 Diabetes Mellitus (Confirmatory Signal)

One-Sentence Summary

Insulin degludec is an ultra-long-acting basal insulin analogue, internationally approved for Type 1 and Type 2 Diabetes Mellitus, but it is not currently marketed in Taiwan. The TxGNN model's top prediction — Type 1 Diabetes Mellitus — is essentially the drug's already-established, globally approved indication rather than a novel repurposing target, supported by 59 clinical trials and 20 publications, including large landmark Phase 3 RCTs.

Quick Overview

Item	Content
Original Indication	Not registered in Taiwan (未上市); internationally approved for Type 1/2 Diabetes Mellitus as basal insulin replacement therapy
Predicted New Indication	Type 1 Diabetes Mellitus
TxGNN Prediction Score	99.44%
Evidence Level	L1
Taiwan Market Status	✗ Not Marketed (未上市)
Number of Authorizations	0
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available (flagged as a High-severity data gap). Based on known pharmacology, insulin degludec is an ultra-long-acting basal insulin analogue that acts directly on the insulin receptor, providing exogenous insulin replacement — its efficacy in Type 1 Diabetes Mellitus has been extensively proven in clinical practice worldwide.

Important caveat: this top-ranked prediction is not a novel repurposing signal. Type 1 Diabetes Mellitus is insulin degludec's already-established, globally approved indication (marketed as Tresiba® in most markets). The TxGNN model here is confirming a known drug-disease relationship rather than uncovering a new therapeutic opportunity. The "not marketed" status recorded under Taiwan regulatory data reflects a market-access gap (the product has not been registered/launched in Taiwan), not a clinical efficacy or safety gap.

Given this, the practical value of this evidence pack is less about validating a new indication and more about supporting a potential Taiwan market-entry decision for a drug with an already mature global evidence base.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT02500706	Phase 3	Completed	1,108	Faster-acting insulin aspart vs NovoRapid®, both combined with insulin degludec, in adults with T1DM
NCT03214367	Phase 3	Completed	1,392	PRONTO-T1D: LY900014 vs insulin lispro, both with glargine or degludec, in T1DM
NCT05904743	Phase 4	Completed	141	INHALE-3: inhaled insulin + degludec vs usual care in T1DM (Grade B relevance)
NCT02030600	Phase 3	Completed	721	SWITCH 2: degludec vs glargine safety/efficacy comparison, ± OADs (Grade A relevance)
NCT01959529	Phase 3	Completed	7,637	DEVOTE: cardiovascular safety of degludec vs glargine in high-CV-risk diabetes — landmark outcomes trial
NCT01984372	N/A (PMS)	Completed	6,163	Long-term (3-year) post-marketing safety/effectiveness surveillance of Tresiba®
NCT02662114	N/A	Completed	2,302	EU-TREAT: real-world effectiveness of degludec after switching basal insulin, T1/T2DM
NCT04450394	Phase 2	Completed	278	LY3209590 vs degludec (active comparator) in insulin-naïve T2DM (Grade B relevance)
NCT03557892	N/A	Completed	28	CSII+CGM vs MDI using degludec as basal insulin, crossover trial in T1DM (Grade C relevance)
NCT01046110	Phase 3	Completed	458	BEGIN™ EARLY: degludec vs sitagliptin add-on in insulin-naïve T2DM (Grade B relevance)

Literature Evidence

PMID	Year	Type	Journal	Key Findings
36623517	2023	RCT	Lancet Diabetes Endocrinol	EXPECT trial: degludec vs detemir (both + aspart) in pregnant women with T1DM, non-inferiority
34643020	2022	RCT	Diabetes Obes Metab	HypoDeg: degludec vs glargine U100 in T1DM prone to nocturnal severe hypoglycaemia
36610544	2023	RCT	Diabetes Res Clin Pract	INEOX: degludec 100 IU/mL vs glargine 300 IU/mL efficacy/safety in T1DM
37863084	2023	Phase 3a RCT	Lancet	ONWARDS 6: once-weekly icodec vs once-daily degludec in T1DM basal-bolus regimen
39270686	2024	Phase 3 RCT	Lancet	QWINT-5: once-weekly efsitora alfa vs degludec in T1DM, non-inferiority
36763996	2022	Systematic Review/Meta-analysis	Clin Ther	Efficacy/tolerability of degludec vs other long-acting basal insulins in T1D/T2D
35476308	2022	Systematic Review	Int J Clin Pharm	Indirect comparison: degludec U100 vs glargine U300 in T1D — safety, efficacy, cost-effectiveness
29477399	2018	Network Meta-Analysis	Value Health	Basal insulin regimens for adults with T1DM: systematic review and network meta-analysis
31055056	2020	Review	Diabetes Metab	Current status of degludec in T1D and T2D based on randomized and observational trials
23890782	2014	Review	Endocrinol Nutr	Degludec, a new ultra-long-acting basal insulin: advances in clinical research

Taiwan Market Information

Insulin degludec currently holds no marketing authorization in Taiwan (0 licenses on record; market status: 未上市). No product entries are available to tabulate.

Safety Considerations

Please refer to the package insert for safety information. No structured warnings, contraindications, or drug interaction data are currently available in this evidence pack (TFDA label data flagged as a Blocking data gap, DG001).

Other Predicted Indications (Not Pursued)

Ranks 2–6 (autoimmune oophoritis, opsismodysplasia, thiamine-responsive dysfunction syndrome, classic stiff person syndrome, focal stiff limb syndrome) all carry L4–L5 evidence with zero supporting clinical trials or literature. These reflect knowledge-graph co-occurrence patterns (e.g., shared GAD65 autoimmunity or diabetes comorbidity) rather than direct pharmacological rationale. All are recommended Hold.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: The top prediction (T1DM) is backed by an extensive, mature L1-level global evidence base (multiple large Phase 3/4 RCTs and landmark outcome trials), but it confirms an already-approved indication rather than a novel repurposing opportunity. The practical decision here is a Taiwan market-access question, not a repurposing-validation question — and it is currently blocked by missing TFDA-specific regulatory data.

To proceed, the following is needed:

TFDA-approved package insert (warnings, contraindications, DDI) — currently a Blocking data gap (DG001)
Confirmed mechanism of action documentation from DrugBank (DG002)
Clarification of Taiwan registration/import status and any planned market-entry timeline for insulin degludec (Tresiba®)
If market entry is pursued, no additional indication-validation studies are needed given the existing global L1 evidence base
Disclaimer

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